[Federal Register Volume 70, Number 188 (Thursday, September 29, 2005)]
[Notices]
[Pages 56911-56925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19510]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0161] (formerly Docket No. 03N-0161)
Medical Devices; Reprocessed Single-Use Devices; Termination of
Exemptions From Premarket Notification; Requirement for Submission of
Validation Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is adding
noncompression heart stabilizers to the list of critical reprocessed
single-use devices (SUDs) whose exemption from premarket notification
requirements has been terminated and for which validation data, as
specified under the Medical Device User Fee and Modernization Act of
2002 (MDUFMA), are necessary in a premarket notification (510(k)). The
agency is also adding laparoscopic and endoscopic electrosurgical
accessories to the list of reprocessed SUDs currently subject to
premarket notification requirements that will now require submission of
supplemental validation data. FDA is requiring submission of these data
to ensure that reprocessed single-use noncompression heart stabilizers
and laparoscopic and endoscopic electrosurgical accessories are
substantially equivalent to predicate devices, in accordance with
MDUFMA.
DATES: These actions are effective September 29, 2005. Manufacturers of
reprocessed single-use noncompression heart stabilizers must submit
510(k)s for these devices by December 29, 2006, or their devices may no
longer be legally marketed. Manufacturers of reprocessed single-use
laparoscopic and endoscopic electrosurgical accessories who already
have 510(k) clearance for these devices must submit supplemental
validation data for the devices by June 29, 2006, or their devices may
no longer be legally marketed.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments should be identified with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Barbara A. Zimmerman, Center for
Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, ext. 158.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250), amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o)
(21 U.S.C. 360(o)), which provided new regulatory requirements for
reprocessed SUDs. According to this new provision, in order to ensure
that reprocessed SUDs are substantially equivalent to predicate
devices, 510(k)s for certain reprocessed SUDs identified by FDA must
include validation data. These required validation data include
cleaning and sterilization data, and functional performance data
demonstrating that each SUD will remain substantially equivalent to its
predicate device after the maximum number of times the device is
reprocessed as intended by the person submitting the premarket
notification.
Before enactment of the new law, a manufacturer of a reprocessed
SUD was required to obtain premarket approval or premarket clearance
for the device, unless the device was exempt from premarket submission
requirements. Under MDUFMA, some previously exempt reprocessed SUDs are
no longer exempt from premarket notification requirements.
Manufacturers of these identified devices were required to submit
510(k)s that included validation data specified by FDA. Reprocessors of
certain SUDs already subject to cleared 510(k)s were also required to
submit the validation data specified by the agency.
The reprocessed SUDs subject to these new requirements were listed
in the Federal Register as required by MDUFMA. In accordance with
section 510(o) of the act, FDA shall revise the lists as appropriate.
This notice adds two types of reprocessed SUDs to the lists of devices
subject to MDUFMA's data submission requirements. Noncompression heart
stabilizers are being added to the list of previously exempt
reprocessed SUDs that now require the submission of 510(k)s containing
validation data. Laparoscopic and endoscopic electrosurgical
accessories are being added to the list of reprocessed SUDs, already
subject to premarket notification requirements, for which supplemental
validation data are required.
A. Definitions
Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an
``original device that has previously been used on a patient and has
been subjected to additional processing and manufacturing for the
purpose of an additional single use on a patient. The subsequent
processing and manufacture of a reprocessed single-use device shall
result in a device that is reprocessed within the meaning of this
definition.''
Reprocessed SUDs are divided into three groups: (1) critical, (2)
semicritical, and (3) noncritical. The first two categories reflect
definitions set forth in MDUFMA, and all three reflect a classification
scheme recognized in the industry.\1\ These categories of devices are
defined as follows:
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\1\Spaulding, E.H., ``The Role of Chemical Disinfection in the
Prevention of Nonsocomial Infections,'' P.S. Brachman and T.C.
Eickof (ed), Proceedings of International Conference on Nonsocomial
Infections, 1970, American Hospital Association, Chicago, 254-274,
1971.
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(1) A critical reprocessed SUD is intended to contact normally
sterile tissue or body spaces during use.
(2) A semicritical reprocessed SUD is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the body.
(3) A noncritical reprocessed SUD is intended to make topical
contact and not penetrate intact skin.
B. Critical and Semicritical Reprocessed SUDs Previously Exempt From
Premarket Notification
MDUFMA required FDA to review the critical and semicritical
reprocessed SUDs that were previously exempt from premarket
notification requirements and determine which of these devices required
premarket notification to ensure their substantial equivalence to
predicate devices. By April 26, 2003, FDA was required to identify in a
Federal Register notice those critical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). According to the law, manufacturers of the
devices whose exemptions from premarket notification were terminated
were required to submit 510(k)s that included validation data regarding
cleaning, sterilization, and functional performance, in addition to all
the other required elements of a 510(k) identified in Sec. 807.87 (21
CFR 807.87), within 15 months of
[[Page 56912]]
publication of the notice or no longer market their devices.
In accordance with section 510(o) of the act, FDA must revise the
list of devices subject to this requirement as appropriate. On June 26,
2003 (68 FR 38071), FDA recategorized nine device types from
semicritical to critical, and added nonelectric gastroenterology-
urology biopsy forceps to the list of critical devices whose exemption
from premarket notification requirements was being terminated.
By April 26, 2004, FDA was required to identify in a Federal
Register notice those semicritical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). As discussed above, manufacturers of the devices
whose exemptions from premarket notification were terminated were
required to submit 510(k)s that included validation data regarding
cleaning, sterilization, and functional performance, in addition to all
the other required elements of a 510(k) identified in Sec. 807.87,
within 15 months of publication of the notice or no longer market their
devices. In accordance with section 510(o) of the act, FDA must revise
the list of devices subject to this requirement as appropriate.
C. Reprocessed SUDs Already Subject to Premarket Notification
Requirements
MDUFMA also required FDA to review the types of reprocessed SUDs
already subject to premarket notification requirements and to identify
which of these devices required the submission of validation data to
ensure their substantial equivalence to predicate devices. FDA
published a list of these devices in the Federal Register on April 30,
2003 (68 FR 23139). As described above, FDA must revise the list of
devices subject to this requirement as appropriate.
For devices identified on this list that had already been cleared
through the 510(k) process, manufacturers were required to submit
validation data regarding cleaning, sterilization, and functional
performance within 9 months of publication of the list or no longer
market their devices.
For devices on this list that were not yet cleared through the
510(k) process, manufacturers were required to submit 510(k)s including
validation data regarding cleaning, sterilization, and functional
performance, in addition to all the other required elements identified
in 21 CFR 807.87, in order to market these devices.
II. FDA's Implementation of New Section 510(o) of the Act
In the Federal Register of April 30, 2003 (68 FR 23139), FDA
described the methodology and criteria used to identify the reprocessed
SUDs that were included in the lists required by MDUFMA. First, FDA
described how it identified the types of SUDs currently being
reprocessed and how the Spaulding definitions (see footnote 1) were
used to categorize these devices as critical, semicritical, or
noncritical. (See Attachment 1.) Next, the agency described its use of
the Risk Prioritization Scheme (RPS)\2\ that was used to evaluate the
potential risk (high, moderate, or low) associated with an SUD based on
the following factors: (1) Risk of infection and (2) risk of inadequate
performance following reprocessing. FDA identified its final criterion
as those reprocessed SUDs intended to come in contact with tissue at
high risk of being infected with the causative agents of Creutzfeldt-
Jakob Disease (CJD). (These are generally devices intended for use in
neurosurgery and ophthalmology.)
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\2\This scheme is described in the February 2000 draft guidance
document entitled, ``Reprocessing and Reuse of Single-Use Devices:
Review Prioritization Scheme.'' http://www.fda.gov/cdrh/reuse/1156.html.
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Using this methodology and these criteria, the devices included on
List I (Critical and Semicritical Reprocessed SUDs Previously Exempt
from Premarket Notification Requirements that Now Require 510(k)s with
Validation Data) of the April 30, 2003, June 26, 2003, and April 13,
2004, Federal Register notices are those critical and semicritical
reprocessed SUDs that were either high risk according to the RPS or
intended to come in contact with tissue at high risk of being infected
with CJD. The devices included on List II (Reprocessed SUDs Subject to
Premarket Notification Requirements that Now Require the Submission of
Validation Data) of the April 30, 2003, Federal Register notice are
those reprocessed SUDs already subject to premarket notification
requirements that were either high risk according to the RPS or
intended to come in contact with tissue at high risk of being infected
with CJD.
III. Revisions to Attachment 1, List I, and List II
A. Revisions to Attachment 1 (List of SUDs Known To Be Reprocessed or
Considered for Reprocessing)
FDA has evaluated the comments received regarding section 510(o) of
the act. In doing so, the agency has determined that all noncompression
heart stabilizers and endoscopic and laparoscopic electrosurgical
accessories should be considered high risk devices when reprocessed.
Noncompression heart stabilizers are intended to move, lift, and
position the heart while maintaining hemodynamic stability during
cardiovascular surgery. The agency has determined that noncompression
heart stabilizers are high risk devices when reprocessed because they
include features, such as narrow tubing, interlocking parts, and small
crevices that could impede cleaning and sterilization and because these
devices contain materials, coatings, or components that may be damaged
or altered by reprocessing. Therefore, these devices have the potential
for a high risk of infection and/or inadequate performance when
reprocessed. This includes noncompression heart stabilizers (device 21
in Attachment 1) classified under Sec. 870.4500 (21 CFR 870.4500). In
determining that noncompression heart stabilizers are high risk devices
when reprocessed, a new product code has been created to identify these
devices within regulation Sec. 870.4500. The new product code is NQG.
This new product code has been added to device 21 in Attachment 1 of
this document.
Endoscopic and laparoscopic electrosurgical accessories are
surgical instruments used during minimally invasive surgery, including
vein harvesting. The agency has determined that these devices should be
considered high risk devices when reprocessed because they include
features, such as narrow lumens, that could impede thorough cleaning
and sterilization and because these devices contain materials,
coatings, or components that may be damaged or altered by reprocessing.
Therefore, these devices have the potential for a high risk of
infection or inadequate performance when reprocessed. This includes
endoscopic and laparoscopic electrosurgical accessories (device 162 in
Attachment 1) classified under Sec. 878.4400 (21 CFR 878.4400). In
determining that endoscopic and laparoscopic electrosurgical
accessories are potentially high risk devices when reprocessed, a new
product code has been created to identify these devices within
regulation Sec. 878.4400. The new product code is NUJ. This new
product code has been added to device 162 in Attachment 1.
These changes are reflected in a revised version of Attachment 1
included in this Federal Register notice.
[[Page 56913]]
B. Revisions to List I (Critical and Semicritical Reprocessed Single-
Use Devices Previously Exempt from Premarket Notification Requirements
that Now Require 510(k)s with Validation Data)
Using the RPS, FDA has recategorized noncompression heart
stabilizers from moderate risk to high risk when reprocessed, and the
agency has therefore added noncompression heart stabilizers to List I.
Manufacturers of noncompression heart stabilizers will be required to
submit 510(k)s with validation data by December 29, 2006, which is 15
months following this revision of the list.
To help reprocessors be able to easily identify those critical and
semicritical reprocessed SUDs that have been categorized into List I in
this notice and previous Federal Register notices, FDA is re-issuing a
complete listing of these devices. Therefore, List 1 now identifies all
critical and semicritical reprocessed SUDs previously exempt from
premarket notification requirements that now require 510(k)s with
validation data.
C. Revisions to List II (Reprocessed Single-Use Devices Subject to
Premarket Notification Requirements that Now Require the Submission of
Validation Data)
Using the RPS, FDA has recategorized endoscopic and laparoscopic
electrosurgical accessories under regulation Sec. 878.4400 from
moderate risk to high risk when reprocessed. Therefore, endoscopic and
laparoscopic electrosurgical accessories have been added to List II.
Under MDUFMA, manufacturers of these devices who have already obtained
clearance through the 510(k) process must submit validation data
regarding cleaning, sterilization, and functional performance by June
29, 2006, which is 9 months following this revision of the list. Upon
publication of this notice, manufacturers who have not yet obtained
clearance through the 510(k) process must submit 510(k)s including
validation data regarding cleaning, sterilization, and functional
performance, in addition to all the other required elements of a 510(k)
identified in 21 CFR 807.87, in order to market these devices.
List I.--Critical and Semicritical Reprocessed Single-Use Devices
Previously Exempt From Premarket Notification Requirements that Now
Require 510(k)s With Validation Data [Manufacturers of noncompression
heart stabilizers will need to submit 510(k)s with validation data by 15
months following the publication of this revised list.]
------------------------------------------------------------------------
Product code Product code
21 CFR Classification Product code for for name for
No. name nonreprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
868.681 Tracheobronchial BSY NQV Tracheobronc
0 suction hial
catheter suction
catheter
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870.450 Cardiovascular MWS NQG Noncompressi
0 surgical on heart
instruments stabilizer
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872.324 Dental bur Diamond coated NME Dental
0 diamond
coated bur
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872.453 Dental diamond DZP NLD Dental
5 instrument diamond
instrument
------------------------------------------------------------------------
872.473 Dental injection DZM NMW Dental
0 needle needle
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872.541 Orthodontic EJF NQS Orthodontic
0 appliance and metal
accessories bracket
------------------------------------------------------------------------
874.414 Ear, nose, and Microdebrider NLY ENT high
0 throat bur speed
microdebrid
er
------------------------------------------------------------------------
874.414 Ear, nose, and Diamond coated NLZ ENT diamond
0 throat bur coated bur
------------------------------------------------------------------------
874.442 Ear, nose, KAB, KBG, KCI NLB Laryngeal,
0 throat manual sinus,
surgical .. tracheal
trocar
------------------------------------------------------------------------
876.107 Gastroenterology- FCL NON Nonelectric
5 urology biopsy biopsy
instrument forceps
------------------------------------------------------------------------
876.468 Ureteral stone FGO, FFL NQT, NQU Flexible and
0 dislodger basket
stone
dislodger
------------------------------------------------------------------------
878.420 Introduction/ GCB NMT Catheter
0 drainage needle
catheter and
accessories
------------------------------------------------------------------------
878.480 Manual surgical MJG NNA Percutaneous
0 instrument biopsy
device
------------------------------------------------------------------------
878.480 Manual surgical FHR NMU Gastro-
0 instrument Urology
needle
------------------------------------------------------------------------
878.480 Manual surgical DWO NLK Cardiovascul
0 instrument for ar biopsy
... .... needle
------------------------------------------------------------------------
878.480 Manual surgical GAA NNC Aspiration
0 instrument and
for... injection
needle
------------------------------------------------------------------------
882.419 Forming/cutting HBS NMN Forming/
0 clip instrument cutting
clip
instrument
------------------------------------------------------------------------
884.173 Laparoscopic HIF NMI Laparoscopic
0 insufflator, .. insufflator
and
accessories
------------------------------------------------------------------------
884.453 OB/GYN HFB NMG Gynecologica
0 specialized l biopsy
manual forceps
instrument
------------------------------------------------------------------------
886.435 Manual HNN NLA Ophthalmic
0 ophthalmic knife
surgical
instrument
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[[Page 56914]]
List II.--Reprocessed Single-Use Devices Subject to Premarket
Notification Requirements That Now Require the Submission of Validation
Data\1\ [Manufacturers of endoscopic and laparoscopic electrosurgical
accessories who already have 510(k) clearance for these devices must
submit validation data by June 29, 2006. Any new 510(k) for this device
type will require validation data upon publication of this document.]
------------------------------------------------------------------------
Product code Product code
21 CFR Classification Product code for for name for
No. name nonreprocessed reprocessed reprocessed
device device device
------------------------------------------------------------------------
Unclass Oocyte MHK NMO Oocyte
ified aspiration aspiration
needles needles
------------------------------------------------------------------------
Unclass Percutaneous LIT NMM Transluminal
ified transluminal peripheral
angioplasty angioplasty
catheter catheter
------------------------------------------------------------------------
Unclass Ultrasonic LFL NLQ Ultrasonic
ified surgical scalpel
instrument
------------------------------------------------------------------------
868.515 Anesthesia BSP NNH Anesthetic
0 conduction conduction
needle needle
(with/
without
introducer)
------------------------------------------------------------------------
868.515 Anesthesia MIA NMR Short term
0 conduction spinal
needle needle
------------------------------------------------------------------------
868.573 Tracheal tube BTR NMA Tracheal
0 tube (with/
without
connector)
------------------------------------------------------------------------
868.590 Noncontinuous BZD NMC Noncontinuou
5 ventilator s
(IPPB) ventilator
(respirator
) mask
------------------------------------------------------------------------
870.120 Diagnostic DQO NLI Angiography
0 intravascular catheter
catheter
------------------------------------------------------------------------
870.122 Electrode DRF NLH Electrode
0 Recording recording
Catheter catheter
------------------------------------------------------------------------
870.122 Electrode MTD NLG Intracardiac
0 Recording mapping
Catheter catheter
------------------------------------------------------------------------
870.123 Fiberoptic DQE NMB Fiberoptic
0 oximeter oximeter
catheter catheter
------------------------------------------------------------------------
870.128 Steerable DRA NKS Steerable
0 Catheter Catheter
------------------------------------------------------------------------
870.129 Steerable DXX NKR Steerable
0 catheter catheter
control system control
system
------------------------------------------------------------------------
870.133 Catheter guide DQX NKQ Catheter
0 wire guide wire
------------------------------------------------------------------------
870.139 Trocar DRC NMK Cardiovascul
0 ar trocar
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870.165 Angiographic DXT NKT Angiographic
0 injector and injector
syringe and syringe
------------------------------------------------------------------------
870.167 Syringe actuator DQF NKW Injector for
0 for injector actuator
syringe
------------------------------------------------------------------------
870.270 Oximeter MUD NMD Tissue
0 saturation
oximeter
------------------------------------------------------------------------
870.270 Oximeter DQA NLF Oximeter
0
------------------------------------------------------------------------
870.353 Intra-aortic DSP NKO Intra-aortic
5 balloon and balloon and
control system control
system
------------------------------------------------------------------------
870.445 Vascular clamp DXC NMF Vascular
0 clamp
------------------------------------------------------------------------
870.488 External vein DWQ NLJ External
5 stripper vein
stripper
------------------------------------------------------------------------
872.547 Orthodontic DYW NLC Orthodontic
0 Plastic Bracket Plastic
Bracket
------------------------------------------------------------------------
874.468 Bronchoscope BWH NLE Bronchoscope
0 (flexible or (nonrigid)
rigid) and biopsy
accessories forceps
------------------------------------------------------------------------
876.107 Gastro-Urology FCG NMX G-U biopsy
5 biopsy needle and
instrument needle set
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876.107 Gastroenterology- KNW NLS Biopsy
5 urology biopsy instrument
instrument
------------------------------------------------------------------------
876.150 Endoscope and FBK, FHP NMY Endoscopic
0 accessories needle
------------------------------------------------------------------------
876.150 Endoscope and MPA NKZ Endoillumina
0 accessories tor
------------------------------------------------------------------------
876.150 Endoscope and GCJ NLM General and
0 accessories plastic
surgery
laparoscope
------------------------------------------------------------------------
[[Page 56915]]
876.150 Endoscope and FHO NLX Spring-
0 accessories loaded
pneumoperit
oneum
needle
------------------------------------------------------------------------
876.430 Endoscopic FAS NLW Active
0 electrosurgical Urological
unit and electrosurg
accessories ical
electrode
------------------------------------------------------------------------
876.430 Endoscopic FEH NLV Flexible
0 electrosurgical suction
unit and coagulator
accessories electrode
------------------------------------------------------------------------
876.430 Endoscopic KGE NLU Electric
0 electrosurgical biopsy
unit and forceps
accessories
------------------------------------------------------------------------
876.430 Endoscopic FDI NLT Flexible
0 electrosurgical snare
unit and
accessories
------------------------------------------------------------------------
876.430 Endoscopic KNS NLR Endoscopic
0 electrosurgical (with or
unit and without
accessories accessories
)
Electrosurg
ical unit
------------------------------------------------------------------------
876.501 Biliary catheter FGE NML Biliary
0 and accessories catheter
------------------------------------------------------------------------
876.554 Blood access LBW NNF Single
0 device and needle
accessories dialysis
set (co-
axial flow)
------------------------------------------------------------------------
876.554 Blood access FIE NNE Fistula
0 device and needle
accessories
------------------------------------------------------------------------
876.582 Hemodialysis FIF NNG Single
0 systems and needle
accessories dialysis
set with
uni-
directional
pump
------------------------------------------------------------------------
878.430 Implantable clip FZP NMJ Implantable
0 clip
------------------------------------------------------------------------
878.440 Electrosurgical GEI NUJ Endoscopic
0 Cutting and and
Coagulation laparoscopi
Device and c
Accessories electrosurg
ical
accessories
------------------------------------------------------------------------
878.475 Implantable GDW NLL Implantable
0 staple staple
------------------------------------------------------------------------
880.557 Hypodermic FMI NKK Hypodermic
0 single lumen single
needle lumen
needle
------------------------------------------------------------------------
880.586 Piston Syringe FMF NKN Piston
0 Syringe
------------------------------------------------------------------------
882.430 Manual cranial HBG NLO (Manual)
0 drills, burrs, drills,
trephines and burrs,
accessories trephines
and
accessories
------------------------------------------------------------------------
882.430 Powered compound HBF NLP (Powered,
5 cranial drills, compound)
burrs, drills,
trephines . burrs,
trephines
and
accessories
------------------------------------------------------------------------
882.431 Powered simple HBE NLN (Simple,
0 cranial drills, powered)
burrs, drills,
trephines . burrs,
trephines
and
accessories
------------------------------------------------------------------------
884.172 Gynecologic HET NMH Gynecologic
0 laparoscope and laparoscope
accessories (and
accessories
)
------------------------------------------------------------------------
884.610 Assisted MQE NNB Assisted
0 reproduction reproductio
needle n needle
------------------------------------------------------------------------
886.437 Keratome HMY, HNO NKY Keratome
0 blade
------------------------------------------------------------------------
886.467 Phacofragmentati HQC NKX Phacoemulsif
0 on system ication
needle
------------------------------------------------------------------------
892.573 Radionuclide IWF NMP Isotope
0 brachytherapy needle
source
------------------------------------------------------------------------
\1\Hemodialyzers have been excluded from this list because the reuse of
hemodialyzers is addressed in ``Draft Guidance for Hemodialyzer Reuse
Labeling'' October 6, 1995. An archived copy may be obtained from
CDRH's Division of Small Manufacturers, International, and Consumer
Assistance, please contact [email protected].
[[Page 56916]]
IV. Stakeholder Input
In the Federal Register of February 4, 2003 (68 FR 5643), FDA
invited interested persons to provide information and share views on
the implementation of MDUFMA. Since that time, the agency has received
comments on various MDUFMA provisions, including several on its
implementation of section 510(o) of the act. As discussed above, one
comment recommended that heart stabilizers should be considered high
risk because of the risk of cross contamination and deterioration of
the mechanical properties of the device. FDA agrees that noncompression
heart stabilizers, a subset of all heart stabilizers, should be added
to the list of critical reprocessed SUDs previously exempt from
premarket notification requirements that will now require 510(k)s with
validation data. Therefore, FDA has added noncompression heart
stabilizers to List I.
Another comment recommended that FDA recategorize endoscopic vessel
harvesting devices as high risk to be consistent with the
categorization of other endoscopic accessories under 21 CFR 876.1500
(Endoscope and accessories). FDA agrees that endoscopic vessel
harvesting devices should be considered high risk and subject to the
submission of validation data. As discussed previously, in reviewing
this comment, the agency also determined that laparoscopic
electrosurgical accessories should be similarly categorized. Therefore,
FDA has added laparoscopic and endoscopic electrosurgical accessories
to List II.
Other additional comments requested that specific reprocessed SUDs
be added to either List I or II. Each of these comments was carefully
considered. However, FDA does not believe, based on the risk-based
approach described in the April 30, 2003, Federal Register notice, that
SUDs other than those identified in this notice should be added to the
Lists at this time.
Another comment requested the FDA to call for the immediate
submission and review of validation data regarding cleaning,
sterilization, and functional performance for all reprocessed SUDs. The
comment further stated that this request was based on the significant
number of reprocessed devices which were withdrawn or were deemed to be
insufficiently supported by validation data as of February 8, 2005.
Section 510(o) of the act required FDA to identify those
reprocessed SUDs for which validation data must be submitted in order
to ensure that those SUDs remain substantially equivalent to predicate
devices after reprocessing. Because the agency has found that some
reprocessed SUDs do not require the submission and review of validation
data in order to demonstrate substantial equivalence, the agency
identified the types of devices requiring the submission of validation
data by implementing a risk-based approach. This risk-based approach,
described in the April 30, 2003, Federal Register notice, identified a
significant number of reprocessed SUDs that can no longer be legally
marketed without agency review and clearance of validation data. The
failure of some manufacturers to submit this validation data and the
agency's review of submitted data resulted in a determination that a
significant number of reprocessed SUDs could no longer be legally
marketed. However, the process also identified a significant number of
reprocessed SUDs that could continue to be marketed because: (1) they
were found not to require the submission of additional validation data
in order to ensure substantial equivalence to legally marketed
predicate devices; or (2) after a review of submitted validation data,
they were found to be substantially equivalent to legally marketed
predicate devices. Therefore, FDA does not intend to expand the list of
reprocessed SUDs subject to the submission and review of validation
data to all reprocessed SUDs as requested in the comment. The agency
believes it has implemented section 510(o) of the act by identifying
the types of devices that require the submission of validation data and
determining which of those devices can no longer be legally marketed.
V. Comments
You may submit written or electronic comments on the designation of
reprocessed noncompression heart stabilizers and laparoscopic and
endoscopic electrosurgical devices requiring the submission of
premarket notifications with validation data to the Division of Dockets
Management (see ADDRESSES). Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit two copies of mailed comments,
but individuals may submit one copy. You should identify your comments
with the docket number found in brackets in the heading of this
document. You may see any comments FDA receives in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing
----------------------------------------------------------------------------------------------------------------
Critical/
Medical Device Type Regulation Class Product Risk\A\ Semicritical/ Premarket
Specialty Number Code Noncritical Exempt
----------------------------------------------------------------------------------------------------------------
1 Cardio Cardiopulmo Unclassified ........ MAB 1 C N
nary
Bypass
Marker
----------------------------------------------------------------------------------------------------------------
2 Cardio Percutaneou Post- III LOX 3 C N
s & amendment
Operative
Translumin
al
Coronary
Angioplast
y Catheter
(PTCA)
----------------------------------------------------------------------------------------------------------------
3 Cardio Percutaneou Post- III LPB 3 C N
s Ablation amendment
Electrode
----------------------------------------------------------------------------------------------------------------
4 Cardio Peripheral 870.1250 II LIT 3 C N
Translumin
al
Angioplast
y (PTA)
Catheter
----------------------------------------------------------------------------------------------------------------
5 Cardio Blood- 870.1120 II DXQ 1 N N
Pressure
Cuff
----------------------------------------------------------------------------------------------------------------
6 Cardio Angiography 870.1200 II DQO 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
[[Page 56917]]
7 Cardio Electrode 870.1220 II DRF 3 C N
Recording
Catheter
----------------------------------------------------------------------------------------------------------------
8 Cardio High- 870.1220 II MTD 3 C N
Density
Array
Catheter
----------------------------------------------------------------------------------------------------------------
9 Cardio Fiberoptic 870.1230 II DQE 3 C N
Oximeter
Catheter
----------------------------------------------------------------------------------------------------------------
10 Cardio Steerable 870.1280 II DRA 3 C N
Catheter
----------------------------------------------------------------------------------------------------------------
11 Cardio Steerable 870.1290 II DXX 3 C N
Catheter
Control
System
----------------------------------------------------------------------------------------------------------------
12 Cardio Guide Wire 870.1330 II DQX 3 C N
----------------------------------------------------------------------------------------------------------------
13 Cardio Angiographi 870.1390 II DRC 3 C N
c Needle
----------------------------------------------------------------------------------------------------------------
14 Cardio Trocar 870.1390 II DRC 3 C N
----------------------------------------------------------------------------------------------------------------
15 Cardio Syringes 870.1650 II DXT 3 C N
----------------------------------------------------------------------------------------------------------------
16 Cardio Injector 870.1670 II DQF 3 C N
Type
Syringe
Actuator
----------------------------------------------------------------------------------------------------------------
17 Cardio Oximeter 870.2700 II DQA 3 N N
----------------------------------------------------------------------------------------------------------------
18 Cardio Tissue 870.2700 II MUD 3 C N
Saturation
Oximeter
----------------------------------------------------------------------------------------------------------------
19 Cardio Intra- 870.3535 III DSP 3 C N
Aortic
Balloon
System
----------------------------------------------------------------------------------------------------------------
20 Cardio Vascular 870.4450 II DXC 3 C N
Clamp
----------------------------------------------------------------------------------------------------------------
21 Cardio Heart 870.4500 I MWS 2 C Y
Stabilizer
----------------------------------------------------------------------------------------------------------------
22 Cardio Noncompress 870.4500 I MWS 3 C Y
ion Heart
Stabilizer
----------------------------------------------------------------------------------------------------------------
23 Cardio External 870.4885 II DWQ 3 C N
Vein
Stripper
----------------------------------------------------------------------------------------------------------------
24 Cardio Compressibl 870.5800 II JOW 1 N N
e Limb
Sleeve
----------------------------------------------------------------------------------------------------------------
25 Dental Bur 872.3240 I EJL 1 C Y
----------------------------------------------------------------------------------------------------------------
26 Dental Diamond 872.3240 I EJL 3 C Y
Coated Bur
----------------------------------------------------------------------------------------------------------------
27 Dental Diamond 872.4535 I DZP 3 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
28 Dental AC-Powered 872.4120 II DZH 2 C N
Bone Saw
----------------------------------------------------------------------------------------------------------------
29 Dental Manual Bone 872.4120 II DZJ 2 C N
Drill and
Wire
Driver
----------------------------------------------------------------------------------------------------------------
30 Dental Powered 872.4120 II DZI 2 C N
Bone Drill
----------------------------------------------------------------------------------------------------------------
31 Dental Intraoral 872.4130 I DZA 1 C Y
Drill
----------------------------------------------------------------------------------------------------------------
32 Dental Injection 872.4730 I DZM 3 C Y
needle
----------------------------------------------------------------------------------------------------------------
33 Dental Metal 872.5410 I EJF 3 S Y
Orthodonti
c Bracket
----------------------------------------------------------------------------------------------------------------
34 Dental Plastic 872.5470 II DYW 3 S N
Orthodonti
c Bracket
----------------------------------------------------------------------------------------------------------------
35 ENT Bur 874.4140 I EQJ 1 C Y
----------------------------------------------------------------------------------------------------------------
36 ENT Diamond 874.4140 I EQJ 3 C Y
Coated Bur
----------------------------------------------------------------------------------------------------------------
37 ENT Microdebrid 874.4140 I EQJ 3 C Y
er
----------------------------------------------------------------------------------------------------------------
[[Page 56918]]
38 ENT Microsurgic 874.4490 II LMS 1 S N
al Argon
Fiber
Optic
Laser
Cable, For
Uses Other
Than
Otology,
Including
Laryngolog
y &
General
Use In
Otolaryngo
logy
----------------------------------------------------------------------------------------------------------------
39 ENT Microsurgic 874.4490 II LXR 1 S N
al Argon
Fiber
Optic
Laser
Cable, For
Use In
Otology
----------------------------------------------------------------------------------------------------------------
40 ENT Microsurgic 874.4500 II EWG 1 S N
al Carbon-
Dioxide
Fiber
Optic
Laser
Cable
----------------------------------------------------------------------------------------------------------------
41 ENT Bronchoscop 874.4680 II BWH 3 C N
e Biopsy
Forceps
(Nonrigid)
----------------------------------------------------------------------------------------------------------------
42 ENT Bronchoscop 874.4680 II JEK 1 C N
e Biopsy
Forceps
(Rigid)
----------------------------------------------------------------------------------------------------------------
43 Gastro/ Biopsy 876.1075 I FFF 1 C Y
Urology Forceps
Cover
----------------------------------------------------------------------------------------------------------------
44 Gastro/ Biopsy 876.1075 II KNW 3 C N
Urology Instrument
----------------------------------------------------------------------------------------------------------------
45 Gastro/ Biopsy 876.1075 II FCG 3 C N
Urology Needle Set
----------------------------------------------------------------------------------------------------------------
46 Gastro/ Biopsy 876.1075 II FCI 2 C N
Urology Punch
----------------------------------------------------------------------------------------------------------------
47 Gastro/ Mechanical 876.1075 II FCF 2 C N
Urology Biopsy
Instrument
----------------------------------------------------------------------------------------------------------------
48 Gastro/ Nonelectric 876.1075 I FCL 3 C Y
Urology Biopsy
Forceps
----------------------------------------------------------------------------------------------------------------
49 Gastro/ Cytology 876.1500 II FDX 2 S N
Urology Brush For
Endoscope
----------------------------------------------------------------------------------------------------------------
50 Gastro/ Endoscope 876.1500 II KOG 2 S N
Urology accessorie
s
----------------------------------------------------------------------------------------------------------------
51 Gastro/ Extraction 876.1500 II KOG 2 S N
Urology Balloons/
Baskets
----------------------------------------------------------------------------------------------------------------
52 Gastro/ Endoscopic 876.1500 II FBK 3 C N
Urology needle
----------------------------------------------------------------------------------------------------------------
53 Gastro/ Simple 876.1500 II FHP 3 C N
Urology Pneumoperi
toneum
Needle
----------------------------------------------------------------------------------------------------------------
54 Gastro/ Spring 876.1500 II FHO 3 C N
Urology Loaded
Pneumoperi
toneum
Needle
----------------------------------------------------------------------------------------------------------------
55 Gastro/ Active 876.4300 II FAS 3 S N
Urology Electrosur
gical
Electrode
----------------------------------------------------------------------------------------------------------------
56 Gastro/ Biliary 876.5010, II FGE 3 C N
Urology Sphinctero 876.1500
tomes
----------------------------------------------------------------------------------------------------------------
57 Gastro/ Electric 876.4300 II KGE 3 C N
Urology Biopsy
Forceps
----------------------------------------------------------------------------------------------------------------
58 Gastro/ Electrosurg 876.4300 II KNS 3 S N
Urology ical
Endoscopic
Unit (With
Or Without
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
[[Page 56919]]
59 Gastro/ Flexible 876.4300 II FDI 3 S N
Urology Snare
----------------------------------------------------------------------------------------------------------------
60 Gastro/ Flexible 876.4300 II FEH 3 S N
Urology Suction
Coagulator
Electrode
----------------------------------------------------------------------------------------------------------------
61 Gastro/ Flexible 876.4680 II FGO 3 S Y
Urology Stone
Dislodger
----------------------------------------------------------------------------------------------------------------
62 Gastro/ Metal Stone 876.4680 II FFL 3 S Y
Urology Dislodger
----------------------------------------------------------------------------------------------------------------
63 Gastro/ Needle 876.4730 I FHQ 1 C Y
Urology Holder
----------------------------------------------------------------------------------------------------------------
64 Gastro/ Nonelectric 876.4730 I FGX 1 S Y
Urology al Snare
----------------------------------------------------------------------------------------------------------------
65 Gastro/ Urological 876.5130 II KOD 2 S N
Urology Catheter
----------------------------------------------------------------------------------------------------------------
66 Gastro/ Single 876.5540 II LBW, FIE 3 C N
Urology needle
dialysis
set
----------------------------------------------------------------------------------------------------------------
67 Gastro/ Hemodialysi 876.5820 II KOC 2 S N
Urology s Blood
Circuit
Accessorie
s
----------------------------------------------------------------------------------------------------------------
68 Gastro/ Single 876.5820 II FIF 3 C N
Urology needle
dialysis
set
----------------------------------------------------------------------------------------------------------------
69 Gastro/ Hemorrhoida 876.4400 II FHN 2 C N
Urology l Ligator
----------------------------------------------------------------------------------------------------------------
70 General Implanted, Post- III LKK 3 C N
Hospital Programmab amendment
le
Infusion
Pump
----------------------------------------------------------------------------------------------------------------
71 General Needle Post- III MTV 1 N N
Hospital Destructio amendment
n Device
----------------------------------------------------------------------------------------------------------------
72 General Nonpowered 880.5150 I IKY 2 N Y
Hospital Flotation
Therapy
Mattress
----------------------------------------------------------------------------------------------------------------
73 General NonAC- 880.5510 I FSA 2 N Y
Hospital Powered
Patient
Lift
----------------------------------------------------------------------------------------------------------------
74 General Alternating 880.5550 II FNM 1 N Y
Hospital Pressure
Air
Flotation
Mattress
----------------------------------------------------------------------------------------------------------------
75 General Temperature 880.5560 I FOH 2 N Y
Hospital Regulated
Water
Mattress
----------------------------------------------------------------------------------------------------------------
76 General Hypodermic 880.5570 II FMI 3 C N
Hospital Single
Lumen
Needle
----------------------------------------------------------------------------------------------------------------
77 General Piston 880.5860 II FMF 3 C N
Hospital Syringe
----------------------------------------------------------------------------------------------------------------
78 General Mattress 880.6190 I FMW 2 N Y
Hospital Cover
(Medical
Purposes)
----------------------------------------------------------------------------------------------------------------
79 General Disposable 880.6820 I JOK 1 N Y
Hospital Medical
Scissors
----------------------------------------------------------------------------------------------------------------
80 General Irrigating 880.6960 I KYZ, KYY 1 C Y
Hospital Syringe
----------------------------------------------------------------------------------------------------------------
81 Infection Surgical 878.4040 II FYA 1 C N
Control Gowns
----------------------------------------------------------------------------------------------------------------
82 Lab Blood 878.4800 I FMK 1 C Y
Lancet
----------------------------------------------------------------------------------------------------------------
[[Page 56920]]
83 Neurology Clip 882.4190 I HBS 3* C Y
Forming/
Cutting
Instrument
,
----------------------------------------------------------------------------------------------------------------
84 Neurology Drills, 882.4300 II HBG 3* C N
Burrs,
Trephines
&Accessori
es
(Manual)
----------------------------------------------------------------------------------------------------------------
85 Neurology Drills, 882.4305 II HBF 3* C N
Burrs,
Trephines
&Accessori
es
(Compound,
Powered)
----------------------------------------------------------------------------------------------------------------
86 Neurology Drills, 882.4310 II HBE 3* C N
Burrs,
Trephines
&Accessori
es
(Simple,
Powered)
----------------------------------------------------------------------------------------------------------------
87 OB/GYN Oocyte ............. III MHK 3 C N
aspiration
needle
----------------------------------------------------------------------------------------------------------------
88 OB/GYN Laparoscope 884.1720 I HET 2 C Y
accessorie
s
----------------------------------------------------------------------------------------------------------------
89 OB/GYN Laparoscope 884.1720 II HET 3 C N
Accessorie
s
----------------------------------------------------------------------------------------------------------------
90 OB/GYN Laparoscopi 884.1720 I HET 2 C Y
c
Dissectors
----------------------------------------------------------------------------------------------------------------
91 OB/GYN Laparoscopi 884.1720 I HET 2 C Y
c Graspers
----------------------------------------------------------------------------------------------------------------
92 OB/GYN Laparoscopi 884.1720 I HET 2 C Y
c Scissors
----------------------------------------------------------------------------------------------------------------
93 OB/GYN Insufflator 884.1730 II HIF 3 C Y
accessorie
s (tubing,
Verres
needle,
kits)
----------------------------------------------------------------------------------------------------------------
94 OB/GYN Laparoscopi 884.1730 II HIF 2 N N
c
Insufflato
r
----------------------------------------------------------------------------------------------------------------
95 OB/GYN Endoscopic 884.4100 II HIM 2 N N
Electrocau
tery and
Accessorie
s
----------------------------------------------------------------------------------------------------------------
96 OB/GYN Gynecologic 884.4120 II HGI 2 N N
Electrocau
tery (and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
97 OB/GYN Endoscopic 884.4150 II HIN 2 N N
Bipolar
Coagulator-
Cutter
(and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
98 OB/GYN Culdoscopic 884.4160 II HFI 2 N N
Coagulator
(and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
99 OB/GYN Endoscopic 884.4160 II KNF 2 N N
Unipolar
Coagulator-
Cutter
(and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
100 OB/GYN Hysteroscop 884.4160 II HFH 2 N N
ic
Coagulator
(and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
101 OB/GYN Unipolar 884.4160 II HFG 2 N N
Laparoscop
ic
Coagulator
(and
Accessorie
s)
----------------------------------------------------------------------------------------------------------------
102 OB/GYN Episiotomy 884.4520 I HDK 1 C Y
Scissors
----------------------------------------------------------------------------------------------------------------
103 OB/GYN Umbilical 884.4520 I HDJ 1 C Y
Scissors
----------------------------------------------------------------------------------------------------------------
104 OB/GYN Biopsy 884.4530 I HFB 3 C Y
Forceps
----------------------------------------------------------------------------------------------------------------
105 OB/GYN Assisted 884.6100 II MQE 3 C N
reproducti
on needle
----------------------------------------------------------------------------------------------------------------
106 Ophthalmic Endoillumin 876.1500 II MPA 3* C N
ator
----------------------------------------------------------------------------------------------------------------
107 Ophthalmic Surgical 878.4370 II KKX 2 C N
Drapes
----------------------------------------------------------------------------------------------------------------
108 Ophthalmic Ophthalmic 886.4350 I HNN 3 C Y
Knife
----------------------------------------------------------------------------------------------------------------
[[Page 56921]]
109 Ophthalmic Keratome 886.4370 I HMY, HNO 3 C N
Blade
----------------------------------------------------------------------------------------------------------------
110 Ophthalmic Phacoemulsi 886.4670 II HQC 3 C N
fication
Needle
----------------------------------------------------------------------------------------------------------------
111 Ophthalmic Phacoemulsi 886.4670 II MUS 2 C N
fication/
Phacofragm
entation
Fluidic
----------------------------------------------------------------------------------------------------------------
112 Ophthalmic Phacofragme 886.4670 II HQC 1 N N
ntation
Unit
----------------------------------------------------------------------------------------------------------------
113 Orthopedic Saw Blades 878.4820 I GFA, DWH, 1 C Y
GEY, GET
----------------------------------------------------------------------------------------------------------------
114 Orthopedic Surgical 878.4820 I GEY, GET 1 C Y
Drills
----------------------------------------------------------------------------------------------------------------
115 Orthopedic Arthroscope 888.1100 II HRX 2 C Y
accessorie
s
----------------------------------------------------------------------------------------------------------------
116 Orthopedic Bone Tap 888.4540 I HWX 1 C Y
----------------------------------------------------------------------------------------------------------------
117 Orthopedic Burr 888.4540 I HTT 1 C Y
----------------------------------------------------------------------------------------------------------------
118 Orthopedic Carpal 888.4540 I LXH 2 C Y
Tunnel
Blade
----------------------------------------------------------------------------------------------------------------
119 Orthopedic Countersink 888.4540 I HWW 1 C Y
----------------------------------------------------------------------------------------------------------------
120 Orthopedic Drill Bit 888.4540 I HTW 1 C Y
----------------------------------------------------------------------------------------------------------------
121 Orthopedic Knife 888.4540 I HTS 1 C Y
----------------------------------------------------------------------------------------------------------------
122 Orthopedic Manual 888.4540 I LXH 1 C Y
Surgical
Instrument
----------------------------------------------------------------------------------------------------------------
123 Orthopedic Needle 888.4540 I HXK 1 C Y
Holder
----------------------------------------------------------------------------------------------------------------
124 Orthopedic Reamer 888.4540 I HTO 1 C Y
----------------------------------------------------------------------------------------------------------------
125 Orthopedic Rongeur 888.4540 I HTX 1 C Y
----------------------------------------------------------------------------------------------------------------
126 Orthopedic Scissors 888.4540 I HRR 1 C Y
----------------------------------------------------------------------------------------------------------------
127 Orthopedic Staple 888.4540 I HXJ 1 C Y
Driver
----------------------------------------------------------------------------------------------------------------
128 Orthopedic Trephine 888.4540 I HWK 1 C Y
----------------------------------------------------------------------------------------------------------------
129 Orthopedic Flexible 886.4070 I GEY, HRG 1 C Y
Reamers/ 878.4820
Drills
----------------------------------------------------------------------------------------------------------------
130 Orthopedic External 888.3040 II JEC KTW 2 N N
Fixation 888.3030 KTT
Frame
----------------------------------------------------------------------------------------------------------------
131 Physical Nonheating 890.5500 II NHN 1 N N
Medicine Lamp for
Adjunctive
Use
Inpatient
Therapy
----------------------------------------------------------------------------------------------------------------
132 Physical Electrode 890.1175 II IKD 1 N Y
Medicine Cable,
----------------------------------------------------------------------------------------------------------------
133 Physical External 890.3420 I ISL 2 N Y
Medicine Limb
Component,
Hip Joint
----------------------------------------------------------------------------------------------------------------
134 Physical External 890.3420 I ISY 2 N Y
Medicine Limb
Component,
Knee Joint
----------------------------------------------------------------------------------------------------------------
135 Physical External 890.3420 I ISZ 2 N Y
Medicine Limb
Component,
Mechanical
Wrist
----------------------------------------------------------------------------------------------------------------
136 Physical External 890.3420 I IQQ 2 N Y
Medicine Limb
Component,
Shoulder
Joint
----------------------------------------------------------------------------------------------------------------
[[Page 56922]]
137 Plastic Stapler 878.4800 I GAG, GEF, 2 C Y
Surgery FHM, HBT
----------------------------------------------------------------------------------------------------------------
138 Radiology Isotope 892.5730 II IWF 3 C N
Needle
----------------------------------------------------------------------------------------------------------------
139 Respiratory Endotrachea Unclassified III LNZ 3 C N
l Tube
Changer
----------------------------------------------------------------------------------------------------------------
140 Respiratory Anesthesia 868.5150 II BSP 3 C N
conduction
needle
----------------------------------------------------------------------------------------------------------------
141 Respiratory Short term 868.5150 II MIA 3 C N
spinal
needle
----------------------------------------------------------------------------------------------------------------
142 Respiratory Respiratory 868.5240 I CAI 2 S Y
Therapy
and
Anesthesia
Breathing
Circuits
----------------------------------------------------------------------------------------------------------------
143 Respiratory Oral and 868.5350 I BZB 1 C Y
Nasal
Catheters
----------------------------------------------------------------------------------------------------------------
144 Respiratory Gas Masks 868.5550 I BSJ 1 S Y
----------------------------------------------------------------------------------------------------------------
145 Respiratory Breathing 868.5620 I BYP 1 N Y
Mouthpiece
----------------------------------------------------------------------------------------------------------------
146 Respiratory Tracheal 868.5730 II BTR 3 C N
Tube
----------------------------------------------------------------------------------------------------------------
147 Respiratory Airway 868.5810 I BZA 2 S Y
Connector
----------------------------------------------------------------------------------------------------------------
148 Respiratory CPAP Mask 868.5905 II BZD 3 S N
----------------------------------------------------------------------------------------------------------------
149 Respiratory Emergency 868.5915 II BTM 2 S N
Manual
Resuscitat
or
----------------------------------------------------------------------------------------------------------------
150 Respiratory Tracheobron 868.6810 I BSY 3 S Y
chial
Suction
Catheter
----------------------------------------------------------------------------------------------------------------
151 Surgery AC-powered 878.4820 I HWE 2 C N
Orthopedic
Instrument
and
accessorie
s
----------------------------------------------------------------------------------------------------------------
152 Surgery Breast Unclassified ........ MRD 1 C N
Implant
Mammary
Sizer
----------------------------------------------------------------------------------------------------------------
153 Surgery Ultrasonic Unclassified ........ LFL 3 C N
Surgical
Instrument
----------------------------------------------------------------------------------------------------------------
154 Surgery Trocar 874.4420 I KAB, KBG, 3 C Y
KCI
----------------------------------------------------------------------------------------------------------------
155 Surgery Endoscopic 876.1500 II GCP, GCR 2 C N
Blades
----------------------------------------------------------------------------------------------------------------
156 Surgery Endoscopic 876.1500 II GCP, GCR 1 C N
Guidewires
----------------------------------------------------------------------------------------------------------------
157 Surgery Inflatable 878.3900 I FZF 1 N Y
External
Extremity
Splint
----------------------------------------------------------------------------------------------------------------
158 Surgery Noninflatab 878.3910 I FYH 1 N Y
le
External
Extremity
Splint
----------------------------------------------------------------------------------------------------------------
159 Surgery Catheter 878.4200 I GCB 3 C Y
needle
----------------------------------------------------------------------------------------------------------------
160 Surgery Implantable 878.4300 II FZP 3 C N
Clip
----------------------------------------------------------------------------------------------------------------
161 Surgery Electrosurg 878.4400 II BWA 2 C N
ical and
Coagulatio
n Unit
With
Accessorie
s
----------------------------------------------------------------------------------------------------------------
162 Surgery Electrosurg 878.4400 II HAM 2 C N
ical
Apparatus
----------------------------------------------------------------------------------------------------------------
[[Page 56923]]
163 Surgery Electrosurg 878.4400 II GEI 2 C N
ical NUJ 3
Cutting &
Coagulatio
n Device &
Accessorie
s
----------------------------------------------------------------------------------------------------------------
164 Surgery Electrosurg 878.4400 II DWG 2 C N
ical
Device
----------------------------------------------------------------------------------------------------------------
165 Surgery Electrosurg 878.4400 II JOS 2 C N
ical
Electrode
----------------------------------------------------------------------------------------------------------------
166 Surgery Implantable 878.4750 II GDW 3 C N
Staple,
Clamp,
Clip for
Suturing
Apparatus
----------------------------------------------------------------------------------------------------------------
167 Surgery Percutaneou 878.4800 I MJG 3 C Y
s biopsy
device
----------------------------------------------------------------------------------------------------------------
168 Surgery Gastro- 878.4800 I FHR 3 C Y
Urology
needle
----------------------------------------------------------------------------------------------------------------
169 Surgery Aspiration 878.4800 I GAA 3 C Y
and
injection
needle
----------------------------------------------------------------------------------------------------------------
170 Surgery Biopsy 878.4800 I GEE 1 C Y
Brush
----------------------------------------------------------------------------------------------------------------
171 Surgery Blood 878.4800 I FMK 1 C Y
Lancet
----------------------------------------------------------------------------------------------------------------
172 Surgery Bone Hook 878.4800 I KIK 1 C Y
----------------------------------------------------------------------------------------------------------------
173 Surgery Cardiovascu 878.4800 I DWO 3 C Y
lar Biopsy
Needle
----------------------------------------------------------------------------------------------------------------
174 Surgery Clamp 878.4800 I GDJ 1 C Y
----------------------------------------------------------------------------------------------------------------
175 Surgery Clamp 878.4800 I HXD 1 C Y
----------------------------------------------------------------------------------------------------------------
176 Surgery Curette 878.4800 I HTF 1 C Y
----------------------------------------------------------------------------------------------------------------
177 Surgery Disposable 878.4800 I KDC 1 C Y
Surgical
Instrument
----------------------------------------------------------------------------------------------------------------
178 Surgery Disposable 878.4800 I GAJ 1 C Y
Vein
Stripper
----------------------------------------------------------------------------------------------------------------
179 Surgery Dissector 878.4800 I GDI 1 C Y
----------------------------------------------------------------------------------------------------------------
180 Surgery Forceps 878.4800 I GEN 2 C Y
----------------------------------------------------------------------------------------------------------------
181 Surgery Forceps 878.4800 I HTD 2 C Y
----------------------------------------------------------------------------------------------------------------
182 Surgery Gouge 878.4800 I GDH 1 C Y
----------------------------------------------------------------------------------------------------------------
183 Surgery Hemostatic 878.4800 I HBT 2 C Y
Clip
Applier
----------------------------------------------------------------------------------------------------------------
184 Surgery Hook 878.4800 I GDG 1 C Y
----------------------------------------------------------------------------------------------------------------
185 Surgery Manual 878.4800 I MDM, MDW 1 C Y
Instrument
----------------------------------------------------------------------------------------------------------------
186 Surgery Manual 878.4800 I GZW 1 C Y
Retractor
----------------------------------------------------------------------------------------------------------------
187 Surgery Manual Saw 878.4800 I GDR HAC 1 C Y
and
Accessorie
s
----------------------------------------------------------------------------------------------------------------
188 Surgery Manual Saw 878.4800 I HAC 1 C Y
and
Accessorie
s
----------------------------------------------------------------------------------------------------------------
189 Surgery Manual 878.4800 I FZO 1 C Y
Surgical
Chisel
----------------------------------------------------------------------------------------------------------------
190 Surgery Mastoid 878.4800 I JYD 1 C Y
Chisel
----------------------------------------------------------------------------------------------------------------
191 Surgery Orthopedic 878.4800 I HTZ 1 C Y
Cutting
Instrument
----------------------------------------------------------------------------------------------------------------
192 Surgery Orthopedic 878.4800 I HXR 1 C Y
Spatula
----------------------------------------------------------------------------------------------------------------
[[Page 56924]]
193 Surgery Osteotome 878.4800 I HWM 1 C Y
----------------------------------------------------------------------------------------------------------------
194 Surgery Rasp 878.4800 I GAC 1 C Y
----------------------------------------------------------------------------------------------------------------
195 Surgery Rasp 878.4800 I HTR 1 C Y
----------------------------------------------------------------------------------------------------------------
196 Surgery Retractor 878.4800 I GAD 1 C Y
----------------------------------------------------------------------------------------------------------------
197 Surgery Retractor 878.4800 I HXM 1 C Y
----------------------------------------------------------------------------------------------------------------
198 Surgery Saw 878.4800 I HSO 1 C Y
----------------------------------------------------------------------------------------------------------------
199 Surgery Scalpel 878.4800 I GES 1 C Y
Blade
----------------------------------------------------------------------------------------------------------------
200 Surgery Scalpel 878.4800 I GDZ 1 C Y
Handle
----------------------------------------------------------------------------------------------------------------
201 Surgery Scissors 878.4800 I LRW 1 C Y
----------------------------------------------------------------------------------------------------------------
202 Surgery Snare 878.4800 I GAE 1 C Y
----------------------------------------------------------------------------------------------------------------
203 Surgery Spatula 878.4800 I GAF 1 C Y
----------------------------------------------------------------------------------------------------------------
204 Surgery Staple 878.4800 I GEF 2 C Y
Applier
----------------------------------------------------------------------------------------------------------------
205 Surgery Stapler 878.4800 I GAG 2 C Y
----------------------------------------------------------------------------------------------------------------
206 Surgery Stomach and 878.4800 I FHM 2 C Y
Intestinal
Suturing
Apparatus
----------------------------------------------------------------------------------------------------------------
207 Surgery Surgical 878.4800 I FZS 1 C Y
Curette
----------------------------------------------------------------------------------------------------------------
208 Surgery Surgical 878.4800 I FZT 1 C Y
Cutter
----------------------------------------------------------------------------------------------------------------
209 Surgery Surgical 878.4800 I EMF 1 S Y
Knife
----------------------------------------------------------------------------------------------------------------
210 Surgery Laser 878.4810 II GEX 2 C N
Powered
Instrument
----------------------------------------------------------------------------------------------------------------
211 Surgery AC-Powered 878.4820 I GEY 2 C Y
Motor
----------------------------------------------------------------------------------------------------------------
212 Surgery Bit 878.4820 I GFG 1 C Y
----------------------------------------------------------------------------------------------------------------
213 Surgery Bur 878.4820 I GFF, GEY 1 C Y
----------------------------------------------------------------------------------------------------------------
214 Surgery Cardiovascu 878.4820 I DWH 1 C Y
lar
Surgical
Saw Blade
----------------------------------------------------------------------------------------------------------------
215 Surgery Chisel 878.4820 I KDG 1 C Y
(Osteotome
)
----------------------------------------------------------------------------------------------------------------
216 Surgery Dermatome 878.4820 I GFD 1 C Y
----------------------------------------------------------------------------------------------------------------
217 Surgery Electricall 878.4820 I DWI 2 C Y
y Powered
Saw
----------------------------------------------------------------------------------------------------------------
218 Surgery Pneumatic 878.4820 I GET 2 C Y
Powered
Motor
----------------------------------------------------------------------------------------------------------------
219 Surgery Pneumatical 878.4820 I KFK 2 C Y
ly Powered
Saw
----------------------------------------------------------------------------------------------------------------
220 Surgery Powered Saw 878.4820 I HAB 2 C Y
and
Accessorie
s
----------------------------------------------------------------------------------------------------------------
221 Surgery Saw Blade 878.4820 I GFA 1 C Y
----------------------------------------------------------------------------------------------------------------
222 Surgery Nonpneumati 878.5900 I GAX 1 N Y
c
Tourniquet
----------------------------------------------------------------------------------------------------------------
223 Surgery Pneumatic 878.5910 I KCY 1 N Y
Tourniquet
----------------------------------------------------------------------------------------------------------------
224 Surgery Endoscopic 888.4540 I HXJ 2 C Y
Staplers
----------------------------------------------------------------------------------------------------------------
225 Surgery Trocar 876.1500 II GCJ, DRC 3 C N
870.1390
----------------------------------------------------------------------------------------------------------------
[[Page 56925]]
226 Surgery Surgical 878.4800, I GDZ, GDX, 2 C Y
Cutting 874.4420 GES,
Accessorie KBQ, KAS
s
----------------------------------------------------------------------------------------------------------------
227 Surgery Electrosurg 876.4300 II HAM, GEI, 2 C N
ical 878.4400 FAS
Electrodes/
Handles/
Pencils
----------------------------------------------------------------------------------------------------------------
228 Surgery Scissor 878.4800, I LRW, HDK, 2 C Y
Tips 884.4520, HDJ,
874.4420 JZB, KBD
----------------------------------------------------------------------------------------------------------------
229 Surgery Laser Fiber 878.4810 II GEX EWG 1 C N
Delivery 874.4500 LLW HQF
Systems 886.4390 HHR HQB
884.4550
886.4690
----------------------------------------------------------------------------------------------------------------
\A\Risk categorization may be either:
1 = low risk according to RPS
2 = moderate risk according to RPS
3 = high risk according to RPS
3* = high risk due to neurological use
See section II of this document, ``FDA's Implementation of New Section 510(o) of the Act'' for methodology and
criteria used to identify the risk.
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19510 Filed 9-28-05; 8:45 am]
BILLING CODE 4160-01-S