[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Notices]
[Pages 23139-23148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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 announcing the
availability of a list (List I) of critical reprocessed single-use
devices (SUDs) whose exemption from premarket submission is being
terminated and for which validation data, as specified under the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is
necessary in a premarket notification (510(k)); and a list (List II) of
reprocessed SUDs that are currently subject to 510(k) requirements for
which FDA has determined that validation data, as specified under
MDUFMA, is necessary in a 510(k). FDA is requiring submission of these
data to ensure that these reprocessed SUDs are substantially equivalent
to predicate devices in accordance with MDUFMA.
DATES: These actions are effective April 30, 2003. Manufacturers of
SUDs identified in List I whose exemption is being terminated must
submit 510(k)s for these devices by July 30, 2004, or their devices may
no longer be marketed. Manufacturers who already have clearance letters
for SUDs identified in List II must submit validation data for these
devices by January 30, 2004, or marketing of these devices must cease.
ADDRESSES: Submit written comments to the Dockets Management Branch
(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 on Lists I and II 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.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Pub. L. 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
will no longer be exempt from premarket notification requirements.
Manufacturers of these identified devices will need to submit 510(k)s
that include validation data to be specified by FDA. Reprocessors of
certain SUDs that are currently subject to cleared 510(k)s also will
need to submit the validation data specified by the agency.
In the near future, FDA will publish a guidance document providing
more specific information about the types of validation data that
should be submitted in premarket notification submissions for the
reprocessed SUDs listed in this notice.
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.''
B. Reprocessed SUDs Exempt From Premarket Notification
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
[[Page 23140]]
the industry.\1\ These categories of devices are defined as follows:
---------------------------------------------------------------------------
\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, 1971:254-
274.
---------------------------------------------------------------------------
(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.
1. Requirements for Critical Reprocessed SUDs
MDUFMA requires FDA to review the critical reprocessed SUDs that
are currently exempt from premarket notification requirements and
determine which of these devices require premarket notification to
ensure their substantial equivalence to predicate devices. By April 26,
2003, FDA must identify in a Federal Register notice those critical
reprocessed SUDs whose exemption from premarket notification will be
terminated. List I in this Federal Register notice implements this
MDUFMA requirement.
In accordance with MDUFMA, manufacturers of the devices identified
in List I must submit 510(k)s that include 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 publication of this notice or no
longer market their device.
2. Requirements for Semicritical Reprocessed SUDs
MDUFMA also requires FDA to review the semicritical reprocessed
SUDs that are currently exempt from premarket notification requirements
and determine which of these devices require premarket notification to
ensure their substantial equivalence to predicate devices. FDA must
identify these devices in a notice published in the Federal Register by
April 26, 2004. Manufacturers of devices identified at that time will
be required to submit 510(k)s that include 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 that notice or no longer market
their device.
3. Requirements for Noncritical Reprocessed SUDs
MDUFMA does not require FDA to take any action under this section
for noncritical SUDs that are exempt from premarket submission
requirements.
C. Reprocessed SUDs Already Subject to Premarket Notification
Requirements
MDUFMA also requires FDA to review the types of reprocessed SUDs
already subject to premarket notification requirements and to identify
which of these devices require the submission of validation data to
ensure their substantial equivalence to predicate devices. FDA must
publish a list of these devices in the Federal Register by April 26,
2003, and update the list as necessary. List II of this Federal
Register notice implements this MDUFMA requirement. The devices on List
II may be critical, semicritical, or noncritical reprocessed SUDs.
1. For devices identified in List II that have not yet been cleared
through the 510(k) process, manufacturers must submit 510(k)s that
include 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, upon publication of this notice
in order to market these devices. FDA will soon publish guidance to
help submitters understand what types of validation data should be
included in these 510(k)s.
2. For devices identified in List II that already have been cleared
through the 510(k) process, manufacturers must submit validation data
regarding cleaning, sterilization, and functional performance within
nine months of publication of this notice or marketing must cease. FDA
will soon publish guidance to explain how a 510(k) holder may submit
the additional data now being required to support an earlier clearance.
II. FDA's Implementation of New Section 510(o) of the Act
FDA used a number of criteria to determine which device types
should be included in the lists required by MDUFMA. As part of its
consideration, FDA relied upon the Review Prioritization Scheme (RPS)
it described in the February 2000 draft guidance document entitled
``Reprocessing and Reuse of Single-Use Devices: Review Prioritization
Scheme.'' \2\ In the RPS guidance, FDA set forth factors that could be
used to evaluate risk associated with reprocessed SUDs. This approach
assigned an overall risk to each SUD based on: (1) The risk of
infection and (2) the risk of inadequate performance following
reprocessing. Based on these risk factors, three categories of risk
(high, moderate, and low) were developed. The designation of ``high
risk'' was assigned to those devices that posed the greatest risk of
infection and inadequate performance after reprocessing. In response to
several comments about potential subjectivity of the RPS, FDA did not
use the RPS approach when the agency finalized its enforcement
priorities for reprocessed SUDs on August 14, 2000.
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\2\ This draft guidance document is available on the CDRH Web
site at http//www.fda.gov/cdrh/reuse/1156.pdf.
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FDA has determined, however, that the RPS is an appropriate risk-
based tool for developing the lists required by MDUFMA because the RPS
identifies the devices that are likely to raise the most concerns about
both infection transmission and inadequate performance following
reprocessing. In formulating these lists, the agency also had the
benefit of comments from stakeholders and an internal centerwide
committee to evaluate the results of the RPS and ensure its
consistency. In addition, there was a final review of all the devices
on these lists by the Director of the Office of Device Evaluation. In
this context, the agency believes these steps have adequately addressed
concerns about the subjectivity of the RPS.
In addition to the previous criterion, FDA used one other criterion
to identify those reprocessed SUDs that will be subject to the new
requirements established by MDUFMA. The agency has included in these
lists all 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 ophthalmology. This criterion was included in FDA's
evaluation because insufficient scientific information exists at this
time to establish standard methods to eliminate CJD infectious agents.
Therefore, in order to develop the two lists required by MDUFMA,
FDA used the following process. First, the agency identified the types
of SUDs that are being reprocessed. FDA did this by searching the
510(k) database for any 510(k)s that had been submitted for reprocessed
SUDs and by asking original equipment manufacturers and reprocessors to
provide information about types of devices that were being reprocessed.
Second, FDA determined whether these devices are ``critical,'' ``semi-
critical,'' or ``non-critical''. (These
[[Page 23141]]
definitions reflect the Spaulding \3\ classification and are the same
definitions FDA used earlier in developing its RPS.) FDA then applied
the criteria described previously and ``listed'' any reprocessed SUD
that was either ``high'' risk according to the RPS or intended to come
in contact with tissue at high risk of being infected with the
causative agents of CJD.
---------------------------------------------------------------------------
\3\ 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, 1971:254-
274.
---------------------------------------------------------------------------
All devices identified in List I (previously exempt from 510(k))
have been determined to be critical reprocessed SUDs. In addition to
being critical, they are either high risk according to the RPS or
intended to come in contact with tissue at high risk of being infected
with CJD. It should be noted that not all exempt devices that are
critical have been listed. Critical reprocessed SUDs that are not
listed in List I at this time may be reconsidered in subsequent updates
of the list. The devices in List II (devices currently subject to
510(k) requirements that now will require the submission of validation
data) are either high risk according to the RPS or intended to come in
contact with tissue at high risk of being infected with the causative
agents of CJD.
FDA has also provided a reference list in Attachment 1. To show how
FDA evaluated the risk of a specific device, Attachment 1 includes the
entire group of devices FDA considered when identifying the reprocessed
SUDs in Lists I and II, and shows how FDA applied the criteria that
determined whether the device would be identified on either of these
lists.
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. The agency received several comments that
identified specific reprocessed SUDs to be included in Lists I and II.
The agency considered these recommendations while finalizing this
document. Although FDA's lists do not include all the reprocessed SUDs
that were recommended, the agency believes that those devices that pose
the greatest risk of infection transmission and inadequate performance
have been identified. The agency recognizes, however, that these lists
may need to be re-evaluated and updated over time. Therefore, FDA will
consider comments from the public on additional devices that should be
included in the lists at any time. The agency also notes that MDUFMA
permits FDA to request validation data for a device type that is
subject to 510(k) clearance but not yet included in List II. If this
were to occur, FDA would ensure that manufacturers were aware of this
change in the 510(k) submission requirements for that type of device by
promptly updating the list.
Finally, FDA received one comment that suggested the agency's prior
determinations about risk associated with reprocessed SUDs precluded
FDA from now requiring 510(k)s for devices that were previously exempt
or additional data for devices that were already cleared. FDA believes
that this comment ignores the existence of MDUFMA's requirements. It is
true that FDA had initially developed a regulatory approach for
reprocessed SUDs that sought to treat those devices and original
devices in a similar manner and that FDA had not required additional
data to be submitted for certain reprocessed SUDs under that approach.
However, through MDUFMA Congress clearly stated its intent to have the
agency re-examine its policy with respect to reprocessed SUDs and
legislated additional controls for those devices. FDA is committed to
fulfilling its responsibilities under MDUFMA. The development and
publication of these lists is part of the agency's implementation of
these new statutory provisions.
List I.--Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That
Will Now Require 510(k)s With Validation Data
[To be submitted by July 26, 2004]
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Product code name
21 CFR section Classification name Product code for Non- Product code for for reprocessed
reprocessed device reprocessed device device
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872.3240........ Dental bur......... Diamond Coated NME Dental diamond
coated bur.
872.4535........ Dental diamond DZP NLD Dental diamond
instrument. instrument.
872.4730........ Dental injection DZM NMW Dental needle.
needle.
874.4140........ Ear, nose, and Microdebrider NLY ENT high speed
throat bur. microdebrider.
874.4140........ Ear, nose, and Diamond Coated NLZ ENT diamond coated
throat bur. bur.
874.4420........ Ear, nose, throat KAB, KBG, KCI NLB Laryngeal, Sinus,
manual surgical * Tracheal trocar.
* *.
878.4200........ Introduction/ GCB NMT Catheter needle.
drainage catheter
and accessories.
878.4800........ Manual surgical MJG NNA Percutaneous biopsy
instrument. device.
878.4800........ Manual surgical FHR NMU Gastro-Urology
instrument. needle.
878.4800........ Manual surgical DWO NLK Cardiovascular
instrument for * * biopsy needle.
*.
878.4800........ Manual surgical GAA NNC Aspiration and
instrument for * * injection.
*.
882.4190........ Forming/cutting HBS NMN Forming/cutting
clip instrument. clip instrument.
884.1730........ Laparoscopic HIF NMI Laparoscopic
insufflator * * *. insufflator and
accessories.
884.4530........ OB/GYN specialized HFB NMG Gynecological
manual instrument. biopsy forceps.
886.4350........ Manual ophthalmic HNN NLA Ophthalmic knife.
surgical
instrument.
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[[Page 23142]]
List II.--Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Will Now Require
The Submission of Validation Data \1\
[Manufacturers who already have 510(k) clearance for these devices must submit validation data by January 26,
2004. Any new 510(k) will require validation data upon publication of this list.]
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Product code name
21 CFR section Classification Product code for non- Product code for for reprocessed
name reprocessed device reprocessed device device
----------------------------------------------------------------------------------------------------------------
Unclassified........ Oocyte aspiration MHK NMO Oocyte aspiration
needles. needles.
Unclassified........ Percutaneous LIT NMM Transluminal
transluminal peripheral
angioplasty angioplasty
catheter catheter.
angioplasty
catheter.
Unclassified........ Ultrasonic LFL NLQ Ultrasonic
surgical scalpel.
instrument.
868.5150............ Anesthesia BSP NNH Anesthetic
conduction needle. conduction needle
(with or without
introducer).
868.5150............ Anesthesia MIA NMR Short term spinal
conduction needle. needle.
868.5730............ Tracheal tube..... BTR NMA Tracheal tube
(with or without
connector).
868.5905............ Non[chyph]con[chyp BZD NMC Noncontinuous
h]tin[chyph]u[chy ventilator
ph]ous (IPPB). (respirator)
mask.
870.1200............ Diagnostic DQO NLI Angiography
intravascular catheter.
catheter.
870.1220............ Electrode DRF NLH Electrode
recording recording
catheter. catheter.
870.1220............ Electrode MTD NLG Intracardiac
recording mapping catheter.
catheter.
870.1230............ Fiberoptic DQE NMB Fiberoptic
oximeter catheter. oximeter
catheter.
870.1280............ Steerable catheter DRA NKS Steerable
catheter.
870.1290............ Steerable catheter DXX NKR Steerable catheter
control system. control system.
870.1330............ Catheter guide DQX NKQ Catheter guide
wire. wire.
870.1390............ Trocar............ DRC NMK Cardiovascular
trocar.
870.1650............ Angiographic DXT NKT Angiographic
injector and injector and
syringe. syringe.
870.1670............ Syringe actuator DQF NKW Injector for
for injector. actuator syringe.
870.2700............ Oximeter.......... MUD NMD Tissue saturation
oximeter.
870.2700............ Oximeter.......... DQA NLF Oximeter.
870.3535............ Intra-aortic DSP NKO Intra-aortic
balloon and balloon and
control system. control system.
870.4450............ Vascular clamp.... DXC NMF Vascular clamp.
870.4885............ External vein DWQ NLJ External vein
stripper. stripper.
872.5470............ Orthodontic DYW NLC Orthodontic
plastic bracket. plastic bracket.
874.4680............ Bronchoscope BWH NLE Bronchoscope
(flexible or (nonrigid) biopsy
rigid) and forceps.
accessories.
876.1075............ Gastro-Urology FCG NMX G-U biopsy needle
biopsy instrument. and needle set.
876.1075............ Gastroenterology- KNW NLS Biopsy instrument.
urology biopsy
instrument.
876.1500............ Endoscope and FBK, FHP NMY Endoscopic needle.
accessories.
876.1500............ Endoscope and MPA NKZ Endoilluminator.
accessories.
876.1500............ Endoscope and GCJ NLM General and
accessories. plastic surgery
laparoscope.
876.1500............ Endoscope and FHO NLX Spring-loaded
accessories. Pneumoperitoneum
Needle.
876.4300............ Endoscopic FAS NLW Active urological
electrosurgical electrosurgical
unit and electrode.
accessories.
876.4300............ Endoscopic unit FEH NLV Flexible suction
accessories. coagulator
electrode.
876.4300............ Endoscopic KGE NLU Electric biopsy
electrosurgical forceps.
unit and
accessories.
876.4300............ Endoscopic FDI NLT Flexible snare.
electrosurgical
unit and
accessories.
876.4300............ Endoscopic KNS NLR Endoscopic (with
electrosurgical or without
unit and accessories)
accessories. Electrosurgical
unit.
876.5010............ Biliary catheter FGE NML Biliary catheter.
and accessories.
876.5540............ Blood access LBW NNF Single needle
device and dialysis set (co-
accessories. axial flow).
876.5540............ Blood access FIE NNE Fistula needle.
device and
accessories.
876.5820............ Hemodialysis FIF NNG Single needle
systems and dialysis set with
accessories. and accessories
uni-directional
pump.
878.4300............ Implantable clip.. FZP NMJ Implantable clip.
878.4750............ Implantable staple GDW NLL Implantable
staple.
880.5570............ Hypodermic single FMI NKK Hypodermic single
lumen needle. lumen needle.
880.5860............ Piston syringe.... FMF NKN Piston syringe.
882.4300............ Manual cranial HBG NLO (Manual) drills,
drills, burrs, burrs, burrs,
trephines and trephines and
accessories. accessories.
882.4305............ Powered compound HBF NLP (Powered,
cranial drills, compound) drills,
burrs, trephines burrs, trephines
. . .. and accessories.
882.4310............ Powered simple HBE NLN (Simple, powered)
cranial drills, drills, burrs,
burrs, trephines. trephines and
accessories.
884.1720............ Gynecologic HET NMH Gynecologic
laparoscope and laparoscope (and
accessories. accessories).
884.6100............ Assisted MQE NNB Assisted
reproduction reproduction
needle. needle.
886.4370............ Keratome.......... HMY, HNO NKY Keratome blade.
886.4670............ Phacofragmentation HQC NKX Phacoemulsificatio
system. n needle.
[[Page 23143]]
892.5730............ Radionuclide IWF NMP Isotope needle.
brachytherapy
source.
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\1\ Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in
``Guidance for Hemodialyzer Reuse Labeling'' (final draft issued on October 6, 1995).
III. Comments
You may submit written or electronic comments on these lists to the
Dockets Management Branch (see ADDRESSES). You may submit a single copy
of an electronic comment to http://www.fda.gov/dockets/ecomments. You
should submit two copies of any mailed comments but individuals may
submit one copy. You should identify your comment 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/semi-
Medical specialty Device type Regulation No. Class Product code Risk critical/non- Premarket
1,2,3,3* critical exempt
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........ Cardio............. Cardiopulmonary Unclassified MAB 1 C N
Bypass Marker.
2........ Cardio............. Percutaneous & post amendment III LOX 3 C N
Operative
Transluminal
Coronary
Angioplasty
Catheter (PCTA).
3........ Cardio............. Percutaneous Post III LPB 3 C N
Ablation amendment
Electrode.
4........ Cardio............. Peripheral Unclassified LIT 3 C N
Transluminal
Angioplasty (PTA)
Catheter.
5........ Cardio............. Blood-Pressure 870.1120 II DXQ 1 N N
Cuff.
6........ Cardio............. Angiography 870.1200 II DQO 3 C N
Catheter.
7........ Cardio............. Electrode 870.1220 II DRF 3 C N
Recording
Catheter.
8........ Cardio............. High-Density Array 870.1220 II MTD 3 C N
Catheter.
9........ Cardio............. Fiberoptic 870.1230 II DQE 3 C N
Oximeter Catheter.
10....... Cardio............. Steerable Catheter 870.1280 II DRA 3 C N
11....... Cardio............. Steerable Catheter 870.1290 II DXX 3 C N
Control System.
12....... Cardio............. Guide Wire........ 870.1330 II DQX 3 C N
13....... Cardio............. Angiographic 870.1390 II DRC 3 C N
Needle.
14....... Cardio............. Trocar............ 870.1390 II DRC 3 C N
15....... Cardio............. Syringes.......... 870.1650 II DXT 3 C N
16....... Cardio............. Injector Type 870.1670 II DQF 3 C N
Syringe Actuator.
17....... Cardio............. Oximeter.......... 870.2700 II DQA 3 N N
18....... Cardio............. Tissue Saturation 870.2700 II MUD 3 C N
Oximeter.
19....... Cardio............. Intra-Aortic 870.3535 III DSP 3 C N
Balloon System.
20....... Cardio............. Vascular Clamp.... 870.4450 II DXC 3 C N
21....... Cardio............. Device, 870.4500 I MWS 2 C Y
Stabilizer, Heart.
22....... Cardio............. External Vein 870.4885 II DWQ 3 C N
Stripper.
23....... Cardio............. Compressible Limb 870.5800 II JOW 1 N N
Sleeve.
24....... Dental............. Bur............... 872.3240 I EJL 1 C Y
25....... Dental............. Diamond Coated Bur 872.3240 I EJL 3 C Y
26....... Dental............. Diamond Instrument 872.4535 I DZP 3 C Y
27....... Dental............. AC-Powered Bone 872.4120 II DZH 2 C N
Saw.
28....... Dental............. Manual Bone Drill 872.4120 II DZJ 2 C N
and Wire Driver.
29....... Dental............. Powered Bone Drill 872.4120 II DZI 2 C N
30....... Dental............. Intraoral Drill... 872.4130 I DZA 1 C Y
31....... Dental............. Injection Needle.. 872.4730 I DZM 3 C Y
32....... Dental............. Metal Orthodontic 872.5410 I EJF 3 S Y
Bracket.
33....... Dental............. Plastic 872.5470 II DYW 3 S N
Orthodontic
Bracket.
34....... ENT................ Bur............... 874.4140 I EQJ 1 C Y
35....... ENT................ Diamond Coated Bur 874.4140 I EQJ 3 C Y
36....... ENT................ Microdebrider..... 874.4140 I EQJ 3 C Y
37....... ENT................ Microsurgical 874.4490 II LMS 1 S N
Argon Fiber Optic
Laser Cable, For
Uses Other Than
Otology,
Including
Laryngology &
General Use In
Otolarngology.
38....... ENT................ Microsurgical 874.4490 II LXR 1 S N
Argon Fiber Optic
Laser Cable, For
Use In Otology.
[[Page 23144]]
39....... ENT................ Microsurgical 874.4500 II EWG 1 S N
Carbon-Dioxide
Fiber Optic Laser
Cable.
40....... ENT................ Bronchoscope 874.4680 II BWH 3 S N
Biopsy Forceps
(Non-Rigid).
41....... ENT................ Bronchoscope 874.4680 II JEK 1 S N
Biopsy Forceps
(Rigid).
42....... Gastro/Urology..... Biopsy Forceps 876.1075 I FFF 1 S Y
Cover.
43....... Gastro/Urology..... Biopsy Instrument. 876.1075 II KNW 3 S N
44....... Gastro/Urology..... Biopsy Needle Set. 876.1075 II FCG 3 S N
45....... Gastro/Urology..... Biopsy Punch...... 876.1075 II FCI 2 S N
46....... Gastro/Urology..... Mechanical Biopsy 876.1075 II FCF 2 S N
Instrument.
47....... Gastro/Urology..... Non-Electric 876.1075 I FCL 3 S Y
Biopsy Forceps.
48....... Gastro/Urology..... Cytology Brush For 876.1500 II FDX 2 S N
Endoscope.
49....... Gastro/Urology..... Endoscope 876.1500 II KOG 2 S N
Accessories.
50....... Gastro/Urology..... Extraction 876.1500 II KOG 2 S N
Balloons/Baskets.
51....... Gastro/Urology..... Endoscopic Needle. 876.1500 II FBK 3 C N
52....... Gastro/Urology..... Simple 876.1500 II FHP 3 C N
Pneumoperitoneum
Needle.
53....... Gastro/Urology..... Spring Loaded 876.1500 II FHO 3 C N
Pneumoperitoneum
Needle.
54....... Gastro/Urology..... Active 876.4300 II FAS 3 S N
Electrosurgical
Electrode.
55....... Gastro/Urology..... Biliary 876.5010, II FGE 3 S N
Sphincterotomes. 876.1500
56....... Gastro/Urology..... Electric Biopsy 876.4300 II KGE 3 S N
Forceps.
57....... Gastro/Urology..... Electrosurgical 876.4300 II KNS 3 S N
Endoscopic Unit
(With Or Without
Accessories).
58....... Gastro/Urology..... Flexible Snare.... 876.4300 II FDI 3 S N
59....... Gastro/Urology..... Flexible Suction 876.4300 II FEH 3 S N
Coagulator
Electrode.
60....... Gastro/Urology..... Flexible Stone 876.4680 II FGO 3 S Y
Dislodger.
61....... Gastro/Urology..... Metal Stone 876.4680 II FFL 3 S Y
Dislodger.
62....... Gastro/Urology..... Needle Holder..... 876.4730 I FHQ 1 C Y
63....... Gastro/Urology..... Non-Electrical 876.4730 I FGX 1 S Y
Snare.
64....... Gastro/Urology..... Urological 876.5130 II KOD 2 S N
Catheter.
65....... Gastro/Urology..... Single Needle 876.5540 II LBW, FIE 3 C N
Dialysis Set.
66....... Gastro/Urology..... Hemodialysis Blood 876.5820 II KOC 2 S N
Circuit
Accessories.
67....... Gastro/Urology..... Single Needle 876.5820 II FIF 3 C N
Dialysis Set.
68....... GE/U............... Hemorrhoidal 876.4400 II FHN 2 C N
Ligator.
69....... General............ Implanted, Post-amendment III LKK 3 C N
Hospital........... Programmable
Infusion Pump.
70....... General............ Needle Destruction Post-amendment III MTV 1 N N
Hospital........... Device.
71....... General............ Non-Powered 880.5150 I IKY 2 N Y
Hospital........... Flotation Therapy
Mattress.
72....... General............ Non AC-Powered 880.5510 I FSA 2 N Y
Hospital........... Patient Lift.
73....... General............ Alternating 880.5550 II FNM 1 N Y
Hospital........... Pressure Air
Flotation
Mattress.
[[Page 23145]]
74....... General............ Temperature 880.5560 I FOH 2 N Y
Hospital........... Regulated Water
Mattress.
75....... General............ Hypodermic Single 880.5570 II FMI 3 C N
Hospital........... Lumen Needle.
76....... General............ Piston Syringe.... 880.5860 II FMF 3 C N
Hospital...........
77....... General............ Mattress Cover 880.6190 I FMW 2 N Y
Hospital........... (Medical
Purposes).
78....... General............ Disposable Medical 880.6820 I JOK 1 N Y
Hospital........... Scissors.
79....... General............ Irrigating Syringe 880.6960 I KYZ, 1 C Y
Hospital........... KYY
80....... Infection.......... Surgical Gowns.... 878.4040 II FYA 1 C N
Control............
81....... Lab................ Blood Lancet...... 878.4800 I FMK 1 C Y
82....... Neuro.............. Clip Forming/ 882.4190 I HBS 3* C Y
Cutting
Instrument,.
83....... Neuro.............. Drills, Burrs, 882.4300 II HBG 3* C N
Trephines &
Accessories
(Manual).
84....... Neuro.............. Drills, Burrs, 882.4305 II HBF 3* C N
Trephines &
Accessories
(Compound,
Powered).
85....... Neuro.............. Drills, Burrs, 882.4310 II HBE 3* C N
Trephines &
Accessories
(Simple, Powered).
86....... OB/GYN............. Oocyte aspiration Unclassified II MHK 3 C N
needle.
87....... OB/GYN............. Laparoscope 884.1720 I HET 2 C Y
Accessories.
88....... OB/GYN............. Laparoscope 884.1720 II HET 3 C N
Accessories.
89....... OB/GYN............. Laparoscopic 884.1720 I HET 2 C Y
Dissectors.
90....... OB/GYN............. Laparoscopic 884.1720 I HET 2 C Y
Graspers.
91....... OB/GYN............. Laparoscopic 884.1720 I HET 2 C Y
Scissors.
92....... OB/GYN............. Insufflator 884.1730 II HIF 3 C Y
Accessories
(tubing, Verres
needle, kits).
93....... OB/GYN............. Laparoscopic 884.1730 II HIF 2 N N
Insufflator.
94....... OB/GYN............. Endoscopic 884.4100 II HIM 2 N N
Electrocautery
And Accessories.
95....... OB/GYN............. Gynecologic 884.4120 II HGI 2 N N
Electrocautery
(And Accessories).
96....... OB/GYN............. Endoscopic Bipolar 884.4150 II HIN 2 N N
Coagulator-Cutter
(And Accessories).
97....... OB/GYN............. Culdoscopic 884.4160 II HFI 2 N N
Coagulator (And
Accessories).
98....... OB/GYN............. Endoscopic 884.4160 II KNF 2 N N
Unipolar
Coagulator-Cutter
(And Accessories).
99....... OB/GYN............. Hysteroscopic 884.4160 II HFH 2 N N
Coagulator (And
Accessories).
100...... OB/GYN............. Unipolar 884.4160 II HFG 2 N N
Laparoscopic
Coagulator (And
Accessories).
101...... OB/GYN............. Episiotomy 884.4520 I HDK 1 C Y
Scissors.
102...... OB/GYN............. Umbilical Scissors 884.4520 I HDJ 1 C Y
103...... OB/GYN............. Biopsy Forceps.... 884.4530 I HFB 3 C Y
104...... OB/GYN............. Assisted 884.6100 II MQE 3 C N
reproduction
needle.
105...... Ophthalmic......... Endoilluminator... 876.1500 II MPA 3* C N
106...... Ophthalmic......... Surgical Drapes... 878.4370 II KKX 2 C N
107...... Ophthalmic......... Ophthalmic Knife.. 886.4350 I HNN 3 C Y
108...... Ophthalmic......... Keratome Blade.... 886.4370 Inot exempt HMY, 3 C N
HNO
109...... Ophthalmic......... Phacoemulsificatio 886.4670 II HQC 3 C N
n Needle.
110...... Ophthalmic......... Phacoemulsificatio 886.4670 II MUS 2 C N
n/
Phacofragmentatio
n Fluidic.
111...... Ophthalmic......... Phacofragmentation 886.4670 II HQC 1 N N
Unit.
112...... Ortho.............. Saw Blades........ 878.4820 I GFA, 1 C Y
DWH,
GEY,
GET
113...... Ortho.............. Surgical Drills... 878.4820 I GEY, 1 C Y
GET
114...... Ortho.............. Arthroscope 888.1100 II HRX 2 C Y
accessories.
115...... Ortho.............. Bone Tap.......... 888.4540 I HWX 1 C Y
116...... Ortho.............. Burr.............. 888.4540 I HTT 1 C Y
117...... Ortho.............. Carpal Tunnel 888.4540 I LXH 2 C Y
Blade.
118...... Ortho.............. Countersink....... 888.4540 I HWW 1 C Y
119...... Ortho.............. Drill Bit......... 888.4540 I HTW 1 C Y
[[Page 23146]]
120...... Ortho.............. Knife............. 888.4540 I HTS 1 C Y
121...... Ortho.............. Manual Surgical 888.4540 I LXH 1 C Y
Instrument.
122...... Ortho.............. Needle Holder..... 888.4540 I HXK 1 C Y
123...... Ortho.............. Reamer............ 888.4540 I HTO 1 C Y
124...... Ortho.............. Rongeur........... 888.4540 I HTX 1 C Y
125...... Ortho.............. Scissors.......... 888.4540 I HRR 1 C Y
126...... Ortho.............. Staple Driver..... 888.4540 I HXJ 1 C Y
127...... Ortho.............. Trephine.......... 888.4540 I HWK 1 C Y
128...... Ortho.............. Flexible Reamers/ 886.4070 I GEY, 1 C Y
Drills. 878.4820 HRG
129...... Ortho.............. External Fixation 888.3040 II JEC 2 N N
Frame. 888.3030 KTW
KTT
130...... Physical........... Non-Heating Lamp Unclassified ............ NHN 1 N N
Medicine........... for Adjunctive
Use Inpatient
Therapy.
131...... Physical........... Electrode Cable,.. 890.1175 II IKD 1 N Y
Medicine...........
132...... Physical........... External Limb 890.3420 I ISL 2 N Y
Medicine........... Component, Hip
Joint.
133...... Physical........... External Limb 890.3420 I ISY 2 N Y
Medicine........... Component, Knee
Joint.
134...... Physical........... External Limb 890.3420 I ISZ 2 N Y
Medicine........... Component,
Mechanical Wrist.
135...... Physical........... External Limb 890.3420 I IQQ 2 N Y
Medicine........... Component,
Shoulder Joint.
136...... Plastic............ Stapler........... 878.4800 I GAG, 2 C Y
Surgery............ GEF,
FHM,
HBT
137...... Radiology.......... Isotope Needle.... 892.5730 II IWF 3 C N
138...... Resp............... Endotracheal Tube Unclassified III LNZ 3 C N
Changer.
139...... Resp............... Anesthesia 868.5150 II BSP 3 C N
conduction needle.
140...... Resp............... Short term spinal 868.5150 II MIA 3 C N
needle.
141...... Resp............... Respiratory 868.5240 I CAI 2 S Y
Therapy And
Anesthesia
Breathing
Circuits.
142...... Resp............... Oral And Nasal 868.5350 I BZB 1 C Y
Catheters.
143...... Resp............... Gas Masks......... 868.5550 I BSJ 1 S Y
144...... Resp............... Breathing 868.5620 I BYP 1 N Y
Mouthpiece.
145...... Resp............... Tracheal Tube..... 868.5730 II BTR 3 C N
146...... Resp............... Airway Connector.. 868.5810 I BZA 2 S Y
147...... Resp............... CPAP Mask......... 868.5905 II BZD 3 S N
148...... Resp............... Emergency Manual 868.5915 II BTM 2 S N
Resuscitator.
149...... Resp............... Tracheobronchial 868.6810 I BSY 3 S Y
Suction Catheter.
150...... Surgery............ AC-powered Unclassified HWE 2 C N
Orthopedic
Instrument and
accessories.
151...... Surgery............ Breast Implant Unclassified MRD 1 C N
Mammary Sizer.
152...... Surgery............ Ultrasonic Unclassified LFL 3 C N
Surgical
Instrument.
153...... Surgery............ Trocar............ 874.4420 I KAB, 3 C Y
KBG,
KCI
154...... Surgery............ Endoscopic Blades. 876.1500 II GCP, 2 C N
GCR
155...... Surgery............ Endoscopic 876.1500 II GCP, 1 C N
Guidewires. GCR
156...... Surgery............ Inflatable 878.3900 I FZF 1 N Y
External
Extremity Splint.
157...... Surgery............ Noninflatable 878.3910 I FYH 1 N Y
External
Extremity Splint.
158...... Surgery............ Catheter needle... 878.4200 I GCB 3 C Y
159...... Surgery............ Implantable Clip.. 878.4300 II FZP 3 C N
160...... Surgery............ Electrosurgical 878.4400 II BWA 2 C N
And Coagulation
Unit With
Accessories.
161...... Surgery............ Electrosurgical 878.4400 II HAM 2 C N
Apparatus.
162...... Surgery............ Electrosurgical 878.4400 II GEI 2 C N
Cutting &
Coagulation
Device &
Accessories.
163...... Surgery............ Electrosurgical 878.4400 II DWG 2 C N
Device.
164...... Surgery............ Electrosurgical 878.4400 II JOS 2 C N
Electrode.
165...... Surgery............ Implantable 878.4750 II GDW 3 C N
Staple, Clamp,
Clip for Suturing
Apparatus.
166...... Surgery............ Percutaneous 878.4800 I MJG 3 C Y
biopsy device.
167...... Surgery............ Gastro-Urology 878.4800 I FHR 3 C Y
needle.
[[Page 23147]]
168...... Surgery............ Aspiration and 878.4800 I GAA 3 C Y
injection needle.
169...... Surgery............ Biopsy Brush...... 878.4800 I GEE 1 C Y
170...... Surgery............ Blood Lancet...... 878.4800 I FMK 1 C Y
171...... Surgery............ Bone Hook......... 878.4800 I KIK 1 C Y
172...... Surgery............ Cardiovascular 878.4800 I DWO 3 C Y
Biopsy Needle.
173...... Surgery............ Clamp............. 878.4800 I GDJ 1 C Y
174...... Surgery............ Clamp............. 878.4800 I HXD 1 C Y
175...... Surgery............ Curette........... 878.4800 I HTF 1 C Y
176...... Surgery............ Disposable 878.4800 I KDC 1 C Y
Surgical
Instrument.
177...... Surgery............ Disposable Vein 878.4800 I GAJ 1 C Y
Stripper.
178...... Surgery............ Dissector......... 878.4800 I GDI 1 C Y
179...... Surgery............ Forceps........... 878.4800 I GEN 2 C Y
180...... Surgery............ Forceps........... 878.4800 I HTD 2 C Y
181...... Surgery............ Gouge............. 878.4800 I GDH 1 C Y
182...... Surgery............ Hemostatic Clip 878.4800 I HBT 2 C Y
Applier.
183...... Surgery............ Hook.............. 878.4800 I GDG 1 C Y
184...... Surgery............ Manual Instrument. 878.4800 I MDM, 1 C Y
MDW
185...... Surgery............ Manual Retractor.. 878.4800 I GZW 1 C Y
186...... Surgery............ Manual Saw And 878.4800 I GDR 1 C Y
Accessories. HAC
187...... Surgery............ Manual Saw And 878.4800 I HAC 1 C Y
Accessories.
188...... Surgery............ Manual Surgical 878.4800 I FZO 1 C Y
Chisel.
189...... Surgery............ Mastoid Chisel.... 878.4800 I JYD 1 C Y
190...... Surgery............ Orthopedic Cutting 878.4800 I HTZ 1 C Y
Instrument.
191...... Surgery............ Orthopedic Spatula 878.4800 I HXR 1 C Y
192...... Surgery............ Osteotome......... 878.4800 I HWM 1 C Y
193...... Surgery............ Rasp.............. 878.4800 I GAC 1 C Y
194...... Surgery............ Rasp.............. 878.4800 I HTR 1 C Y
195...... Surgery............ Retractor......... 878.4800 I GAD 1 C Y
196...... Surgery............ Retractor......... 878.4800 I HXM 1 C Y
197...... Surgery............ Saw............... 878.4800 I HSO 1 C Y
198...... Surgery............ Scalpel Blade..... 878.4800 I GES 1 C Y
199...... Surgery............ Scalpel Handle.... 878.4800 I GDZ 1 C Y
200...... Surgery............ Scissors.......... 878.4800 I LRW 1 C Y
201...... Surgery............ Snare............. 878.4800 I GAE 1 C Y
202...... Surgery............ Spatula........... 878.4800 I GAF 1 C Y
203...... Surgery............ Staple Applier.... 878.4800 I GEF 2 C Y
204...... Surgery............ Stapler........... 878.4800 I GAG 2 C Y
205...... Surgery............ Stomach And 878.4800 I FHM 2 C Y
Intestinal
Suturing
Apparatus.
206...... Surgery............ Surgical Curette.. 878.4800 I FZS 1 C Y
207...... Surgery............ Surgical Cutter... 878.4800 I FZT 1 C Y
208...... Surgery............ Surgical Knife.... 878.4800 I EMF 1 S Y
209...... Surgery............ Laser Powered 878.4810 II GEX 2 C N
Instrument.
210...... Surgery............ Ac-Powered Motor.. 878.4820 I GEY 2 C Y
211...... Surgery............ Bit............... 878.4820 I GFG 1 C Y
212...... Surgery............ Bur............... 878.4820 I GFF, 1 C Y
GEY
213...... Surgery............ Cardiovascular 878.4820 I DWH 1 C Y
Surgical Saw
Blade.
214...... Surgery............ Chisel (Osteotome) 878.4820 I KDG 1 C Y
215...... Surgery............ Dermatome......... 878.4820 I GFD 1 C Y
216...... Surgery............ Electrically 878.4820 I DWI 2 C Y
Powered Saw.
217...... Surgery............ Pneumatic Powered 878.4820 I GET 2 C Y
Motor.
218...... Surgery............ Pneumatically 878.4820 I KFK 2 C Y
Powered Saw.
219...... Surgery............ Powered Saw And 878.4820 I HAB 2 C Y
Accessories.
220...... Surgery............ Saw Blade......... 878.4820 I GFA 1 C Y
221...... Surgery............ Nonpneumatic 878.5900 I GAX 1 N Y
Tourniquet.
222...... Surgery............ Pneumatic 878.5910 I KCY 1 N Y
Tourniquet.
223...... Surgery............ Enodoscopic 888.4540 I HXJ 2 C Y
Staplers.
224...... Surgery............ Trocar............ 876.1500 II GCJ, 3 C N
870.1390 DRC
225...... Surgery............ Surgical Cutting 878.4800, I GDZ, 2 C Y
Accessories. 874.4420 GDX,
GES,
KBQ,
KAS
226...... Surgery............ Electrosurgical 876.4300 II HAM, 2 C N
Electrodes/ 878.4400 GEI,
Handles/Pencils. FAS
[[Page 23148]]
227...... Surgery............ Scissor Tips...... 878.4800, I LRW, 2 C Y
884.4520, HDK,
874.4420 HDJ,
JZB,
KBD
228...... Surgery............ Laser Fiber 878.4810 II GEX 1 C N
Delivery Systems. 874.4500 EWG
886.4390 LLW
884.4550 HQF
886.4690 HHR
HQB
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
Dated: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10413 Filed 4-23-03; 5:03 pm]
BILLING CODE 4160-01-P