[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.

-----------------------------------------------------------------------

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:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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.)
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
------------------------------------------------------------------------
870.450  Cardiovascular    MWS               NQG            Noncompressi
 0        surgical                                           on heart
          instruments                                        stabilizer
------------------------------------------------------------------------
872.324  Dental bur        Diamond coated    NME            Dental
 0                                                           diamond
                                                             coated bur
------------------------------------------------------------------------
872.453  Dental diamond    DZP               NLD            Dental
 5        instrument                                         diamond
                                                             instrument
------------------------------------------------------------------------
872.473  Dental injection  DZM               NMW            Dental
 0        needle                                             needle
------------------------------------------------------------------------
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
------------------------------------------------------------------------


[[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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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 <a href="/cdn-cgi/l/email-protection#0763746a6e6466476463756f2961636629606871"><span class="__cf_email__" data-cfemail="b2d6c1dfdbd1d3f2d1d6c0da9cd4d6d39cd5ddc4">[email protected]</span></a>.


[[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


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