[Federal Register: March 31, 2000 (Volume 65, Number 63)]
[Rules and Regulations]
[Page 17138-17148]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr00-10]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 870, 872, 874, 876, 878, 884, 886, and 888

[Docket No. 99N-0035]


Medical Devices; Reclassification of 28 Preamendments Class III
Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is reclassifying 28
preamendments devices from class III (premarket approval) into class II
(special controls). FDA is also identifying the special controls that
the agency believes will reasonably ensure the safety and effectiveness
of the devices. This reclassification is being undertaken on the
agency's own initiative based on new information under the Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical
Devices Act of 1990 and the FDA Modernization Act of 1997. The agency
is also revising the identification of six of the devices subject to
this rule to more accurately reflect the characteristics of devices
actually being marketed. FDA is withholding action on 11 devices, which
the agency proposed to reclassify, pending further action.

DATES: This rule is effective May 1, 2000.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 15, 1999 (64 FR 12774), FDA
published a proposed rule to reclassify 38 preamendments class III
devices into class II and to establish special controls for these
devices. FDA invited interested persons to comment on the proposed rule
by June 14, 1999.
    FDA received one request to reopen the comment period for six
devices. The request noted that FDA had not made the guidance documents
that were proposed as special controls for these six devices available
for comment through FDA's Good Guidance Practices (GGP's). The request
further said that it was impossible to comment on the

[[Page 17139]]

proposed reclassification without the guidance documents being
available. Therefore, the requestor asked that FDA extend the comment
period until at least 90 days after the guidance documents are publicly
available.
    FDA agrees with the request. FDA has also identified an additional
three devices for which FDA had not issued the guidance documents
proposed as special controls in accordance with the GGP policy.
Therefore, FDA is withholding action on the devices listed in table 1
of this document at this time. FDA will make the guidance documents for
these devices available for comment through the GGP process and will
reopen the comment period on the reclassification of these devices when
the guidance documents are available.
    FDA also received a request for an extension of the comment period
for the cutaneous oxygen monitor (Sec. 868.2500 (21 CFR 868.2500)) on
behalf of a foreign manufacturer. The manufacturer needed additional
time to translate the proposed special controls documents to prepare
their comments. FDA granted this request and will withhold action on
this device and reopen the comment period.

         Table 1.--Devices Not Subject of This Reclassification
------------------------------------------------------------------------
           21 CFR Section                         Device Name
------------------------------------------------------------------------
868.1150                             Indwelling blood carbon dioxide
                                      partial pressure (Pco\2\) analyzer
868.1170                             Indwelling blood hydrogen ion
                                      concentration (pH) analyzer
868.1200                             Indwelling blood oxygen partial
                                      pressure (Po\2\) analyzer
868.2500                             Cutaneous oxygen monitor
870.3450                             Vascular graft prosthesis of less
                                      than 6 millimeters diameter
870.3620                             Pacemaker lead adaptor
870.3800                             Annuloplasty ring
870.4230                             Cardiopulmonary bypass defoamer
870.4260                             Cardiopulmonary bypass arterial
                                      blood line filter
870.4350                             Cardiopulmonary bypass oxygenator
------------------------------------------------------------------------

II. Comments

    FDA received five comments on the proposal. The following is a
summary of the comments and FDA's response:
    (Comment 1) One comment supported the proposal to reclassify four
orthopedic devices: The elbow joint metal/polymer constrained cemented
prosthesis (Sec. 888.3150 (21 CFR 888.3150)), the knee joint
patellofemoral polymer/metal semi-constrained cemented prosthesis
(Sec. 888.3540 (21 CFR 888.3540)), the shoulder joint metal/polymer
non-constrained cemented prosthesis (Sec. 888.3650 (21 CFR 888.3650)),
and the shoulder joint metal/polymer semi-constrained cemented
prosthesis (Sec. 888.3660 (21 CFR 888.3660)).
    FDA agrees with this comment.
    (Comment 2) One comment supported the proposed reclassification and
special controls for the tinnitus masker (Sec. 874.3400 (21 CFR
874.3400)).
    FDA agrees with this comment.
    (Comment 3) A third comment addressed the vascular graft prosthesis
of less than 6 millimeters diameter (Sec. 870.3450).
    As noted above, FDA is withholding action on this device, until the
proposed guidance document intended to be a special control is made
available for comment. FDA will address this comment when it takes
final action on this device.
    (Comment 4) One manufacturer agreed with the proposal to reclassify
the over-the-counter (OTC) denture cushion or pad (Sec. 872.3540 (21
CFR 872.3540)) but recommended that it be reclassified from class III
into class I. The manufacturer submitted data on the device to support
the claim that general controls are adequate to provide reasonable
assurance of the safety and effectiveness of the device. The comment
agreed that proper labeling is important to control risks to health
associated with the use of this device.
    FDA disagrees with this comment. FDA believes it is necessary that
consumers have appropriate directions for use to correctly prepare
denture material for a properly fitted denture. The guidance document
describes the information necessary to provide reasonable assurance of
the safe and effective use of the OTC dental pad or cushion. In
particular, it includes descriptive information on the indications for
use, contraindications, cautions, and potential adverse effects for the
device, as well as the directions for use information regarding
adequate mixing, preparation, and use of the product. The guidance
document also provides ways that a manufacturer can establish that
there is reasonable assurance that an OTC denture cushion or pad with a
new intended use, chemical composition, labeling claims, or method of
preparation is safe and effective.
    (Comment 5) One comment raised three issues concerning the proposed
reclassification of the high permeability hemodialysis system
(Sec. 876.5860 (21 CFR 876.5860)) as follows:
    1. The comment recommended changing the name and the section
heading of Sec. 876.5860 to include three additional therapies:
Hemofiltration, hemoconcentration, and hemodiafiltration.
    FDA notes that it has cleared these three additional renal
therapies identified by the comment under Sec. 876.5860. FDA will not
revise the name of the device but it will revise the first sentence of
the identification section (Sec. 876.5860(a)) as follows: ``A high
permeability hemodialysis system is a device intended for use as an
artificial kidney system for treatment of patients with renal failure,
fluid overload, or toxemic conditions by performing such therapies as
hemodialysis, hemofiltration, hemoconcentration, and
hemodiafiltration.''
    2. The comment also recommended further revising the identification
of the high permeability hemodialysis system to state that the
hemofiltration, hemoconcentration, and hemodiafiltration
ultrafiltration coeficient (K<INF>uf</INF> ) should be changed from
``greater than 12 ml/hr/mmHg'' to ``greater than 8 ml/hr/mmHg''.
    FDA agrees with the comment with the provision that the bovine or
expired human blood be used to measure the K<INF>uf</INF>. In the final
rule, Sec. 876.5860(a)(1) is revised to read:
    The hemodialyzer consists of a semipermeable membrane with an in
vitro ultrafiltration coefficient (K<INF>uf</INF>) greater than 8
milliliters per hour per conventional millimeter of mercury, as
measured with bovine or expired human blood, and is used with either an
automated ultrafiltration controller or another method of
ultrafiltration control to prevent fluid imbalance.
    3. The comment also recommended that any revisions to the
hemodialysis-related guidance documents be implemented as Level 1
guidance documents under FDA's GGP's.
    FDA will follow its GGP's in issuing revisions to guidance
documents used as special controls for this device as well as for all
devices.
    (Comment 6) FDA also made the following changes on its own
initiative for accuracy and clarity:
    1. FDA incorrectly cited the title of its biocompatibility guidance
and is correcting the title of the guidance to read, ``Use of
International Standard ISO 10993 `Biological Evaluation of Medical
Devices Part I: Evaluation and Testing'.''

[[Page 17140]]

The special control is the FDA guidance document and not the ISO
consensus standard itself.
    2. In Sec. 874.3930--Tympanostomy tube with semipermeable membrane
(21 CFR 874.3930), FDA deleted the proposed special controls except the
device specific guidance document. FDA believes that the guidance
document adequately addresses the other proposed special controls.
    3. In Sec. 876.4480--Electrohydraulic lithotriptor (21 CFR
876.4480), FDA deleted the proposed special controls except the device
specific FDA guidance document. FDA believes that the guidance document
adequately addresses the other proposed special controls.
    4. In Sec. 876.5860--High permeability hemodialysis system, FDA
deleted the American National Standards Institute (ANSI)/Association
for the Advancement in Medical Instrumentation (AAMI) and United States
Pharmacopeia (USP) standards because FDA believes that these standards
are adequately addressed in the FDA sterility guidance.
    5. In Sec. 884.1060--Endometrial aspirator (21 CFR 884.1060); 21
CFR 884.1110--Endometrial brush; and Sec. 884.1185--Endometrial washer
(21 CFR 884.1185), FDA clarified the wording of the labeling and design
and testing special controls.
    6. In Sec. 884.4100--Endoscopic electrocautery and accessories (21
CFR 884.4100), and Sec. 884.4150--Bipolar endoscopic coagulator-cutter
and accessories (21 CFR 884.4150), FDA added the complete titles and
years of the standards and clarified the labeling and treatment
instructions. In the preamble to the proposed rule, FDA identified the
sterility guidance as a special control for these two devices but did
not include it in the regulatory text. FDA has included the sterility
guidance in the regulatory text of the final rule.
    7. In some device identifications, FDA made minor editorial
changes.

III. FDA's Conclusion

    FDA has concluded, based on a review of the available information,
that the special controls identified in tables 2 and 3 of this document
provide reasonable assurance of the safety and effectiveness of these
28 devices. The two tables summarize the special controls to be applied
to each device.

                       Table 2.--Summary of FDA Guidance Special Controls Listed by Device
----------------------------------------------------------------------------------------------------------------
                                           FDA Sterility Review    FDA Biocompatibility
21 CFR Section        Device Name               Guidance<SUP>1</SUP>                Guidance<SUP>2</SUP>          Other FDA Guidance
----------------------------------------------------------------------------------------------------------------
    864.7250    Erythropoietin Assay                                                      3
    864.7300    Fibrin monomer                                                            4
                 paracoagulation test
    870.3375    Cardiovascular           X                        X                       5
                 intravascular filter
    872.3540    OTC denture cushion or                            X                       6
                 pad
    872.3560    OTC denture reliner                               X                       6
    872.3570    OTC denture repair kit                            X                       6
    872.3600    Partially fabricated                              X                       6
                 denture kit
    874.3930    Tympanostomy tube with                                                    7
                 semipermeable membrane
    876.4480    Electrohydraulic                                                          8
                 lithotriptor
    876.5860    High permeability                                 X                       9,10,11,12
                 hemodialysis system
    876.5955    Peritoneo-venous shunt   X                        X
    878.3610    Esophageal prosthesis                                                     13
    878.3720    Tracheal prosthesis                                                       13
    884.1060    Endometrial aspirator    X                        X
    884.1100    Endometrial brush        X                        X
    884.1185    Endometrial washer       X                        X
    884.4100    Endoscopic               X                        X                       14
                 electrocautery and
                 accessories
    884.4150    Bipolar endoscopic       X                        X                       14
                 coagulator-cutter
    886.3400    Keratoprosthesis         X                        X                       15
    886.3920    Eye valve implant        X                        X                       16
    888.3150    Elbow joint metal/       X                        X                       17,18,19
                 polymer constrained
                 cemented prosthesis
    888.3540    Knee joint               X                        X                       17,18,19
                 patellofemoral polymer/
                 metal semi-constrained
                 cemented prosthesis
    888.3650    Shoulder joint metal/    X                        X                       17,18,19
                 polymer non-
                 constrained cemented
                 prosthesis
    888.3660    Shoulder joint metal/    X                        X                       17,18,19
                 polymer semi-
                 constrained cemented
                 prosthesis
----------------------------------------------------------------------------------------------------------------
(1) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1)''
(2) ``Use of International Standard ISO 10993 `Biological Evaluation of Medical Devices Part I: Evaluation and
  Testing,' ''
(3) `` Document for Special Controls for Erythropoietin Assay Premarket Notification [510(k)s],''
(4) ``In Vitro Diagnostic Fibrin Monomer Paracoagulation Test, ''
(5) ``Guidance for Cardiovascular Intravascular Filters 510(k) Submissions,''
(6) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits,''
(7) ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification,''
(8) ``Guidance for the Content of Premarket Notifications for Intracorporal Lithotripters,''

[[Page 17141]]

(9) ``Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,''
(10) ``Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis
  Delivery Systems,''
(11) ``Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for
  Hemodialysis,''
(12) ``Guidance for Hemodialyzer Reuse Labeling,''
(13) ``Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses,
(14) ``Guidance (`Guidelines') for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and
  Accessories),''
(15) ``Guidance on 510(k) Submissions for Keratoprosthesis,''
(16) ``Aqueous Shunt-510(k) Submissions,''
(17 ``Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone
  Cement,''
(18) ``Guidance Document for Testing Non-articulating, `Mechanically Locked' Modular Implant Components,'' and
(19) ``Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic
  Devices.''

                                Table 3.--Other Special Controls Listed by Device
----------------------------------------------------------------------------------------------------------------
                                                                                                 Design and
    21 CFR Section          Device Name              Labeling              Standards         Performance Testing
----------------------------------------------------------------------------------------------------------------
866.3510               Rubella virus                                 NCCLS \1\              ....................
                        serological reagents                           1/LA6, October
                                                                      1997,
                                                                       1/LA18, December
                                                                      1994,
                                                                       D13, October 1993,
                                                                       EP5, February 1999,
                                                                       EP10, May 1998.
                                                                       CDC \2\
                                                                       Low Titer Rubella
                                                                      Standard,
                                                                       Reference Panel of
                                                                      Well Characterized
                                                                      Rubella Sera.
                                                                       WHO \3\
                                                                       Rubella Standard.
870.5550               External                                      ANSI/AAMI \4\          The maximum pulse
                        transcutaneous                                 DF-2                  amplitude should
                        cardiac pacemaker                                                    not exceed 200 mA.
                        (noninvasive)                                                        The maximum pulse
                                                                                             duration should not
                                                                                             exceed 50 msec.
872.6080               Airbrush                                      IEC \5\
                                                                       60601-1-AM2 (1995-
                                                                      03),
                                                                       Amendment 2
874.3400               Tinnitus masker        Patient labeling re:
                                               hearing health care
                                               professional
                                               diagnosis, fitting
                                               and followup care;
                                               risks; benefits;
                                               warnings; and
                                               specifications.
876.5955               Peritoneo-venous                                                     Backflow
                        shunt                                                                specifications to
                                                                                             prevent reflux of
                                                                                             blood into the
                                                                                             shunt.
884.1060               Endometrial aspirator  Indication: Only to                           Sampling component
                                               evaluate the                                  is covered within
                                               endometrium.                                  the vagina.
                                              Contraindications:
                                               pregnancy, history
                                               of recent uterine
                                               perforation, and
                                               recent cesarean
                                               section.
884.1100               Endometrial brush      Indication: Only to                           Sampling component
                                               evaluate the                                  is covered within
                                               endometrium.                                  the vagina.
                                              Contraindications:                            Adherence of
                                               Pregnancy, history                            bristles and brush
                                               of recent uterine                             head.
                                               perforation, and
                                               recent cesarean
                                               section.
884.1185               Endometrial washer     Indication: Only to                           Maximum intrauterine
                                               evaluate the                                  pressure should not
                                               endometrium.                                  exceed 50
                                              Contraindications:                             millimeters of
                                               Pregnancy, history                            mercury.
                                               of recent uterine                            Sampling component
                                               perforation, and                              is covered within
                                               recent cesarean                               the vagina
                                               section.
                                              Warning: Do not
                                               attach to wall or
                                               any external
                                               suction.

[[Page 17142]]

884.4100               Endoscopic             Indication: For        ANSI/AAMI
                        electrocautery and     female tubal            HF-18
                        accessories            sterilization.        IEC
                                              Instructions for use:    60601-1-1-AM2
                                              Destroy at least 2 cm    (1995-03) Amendment
                                               of the fallopian       2
                                               tube;
                                              Use a cut (or
                                               undampened
                                               sinusoidal) wave
                                               form; and
                                              Use a minimum power
                                               of 25 watts.
                                              For devices with
                                               ammeters: continue
                                               electrode activation
                                               for 5 seconds after
                                               the visual endpoint
                                               (tissue blanching)
                                               is reached or
                                               current flow ceases
                                               indicating adequate
                                               tissue destruction.
884.4150               Bipolar endoscopic     Indication: For        ANSI/AAMI
                        coagulator-cutter      female tubal            HF-18
                                               sterilization.        IEC
                                              Instructions for use:    60601-1-1-AM2
                                              Destroy at least 2 cm    (1995-03) Amendment
                                               of the fallopian       2
                                               tube;
                                              Use a cut (or
                                               undampened
                                               sinusoidal) wave
                                               form; and
                                              Use a minimum power
                                               of 25 watts.
                                              For devices with
                                               ammeters: continue
                                               electrode activation
                                               for 5 seconds after
                                               the visual endpoint
                                               (tissue blanching)
                                               is reached or
                                               current flow ceases
                                               indicating adequate
                                               tissue destruction.
888.3150               Elbow joint metal/                            ASTM \6\
                        polymer constrained                            F 75-92,
                        cemented prosthesis                            F 648-98,
                                                                       F 799-96,
                                                                       F 981-93,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95,
                                                                       F 1537-94.
                                                                     ISO \7\
                                                                       5832-3,4, &
                                                                      12:1996,
                                                                       5833:1992,
                                                                       5834-2;1998,
                                                                       6018:1997,
                                                                       9001:1994,
                                                                       14630:1997.
888.3540                 Knee joint                                  ASTM
                        patellofemoral                                 F 75-92,
                        polymer/metal semi-                            F 648-98
                        constrained cemented                           F 799-96,
                        prosthesis                                     F 1044-95
                                                                       F 1108-97,
                                                                       F 1147-95,
                                                                       F 1537-94,
                                                                       F 1672-95.
                                                                     ISO
                                                                       5832-3,4, &
                                                                      12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       7207-2:1998,
                                                                       9001:1994.

[[Page 17143]]

888.3650               Shoulder joint metal/                         ASTM
                        polymer non-                                   F 75-92,
                        constrained cemented                           F 648-98,
                        prosthesis                                     F 799-96,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95;
                                                                       F-1378-97,
                                                                       F 1537-94.
                                                                     ISO
                                                                       5832-3,4 & 12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       9001:1994.
888.3660               Shoulder joint metal/                         ASTM
                        polymer semi-                                  F 75-92,
                        constrained cemented                           F 648-98,
                        prosthesis                                     F 799-96,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95;
                                                                       F 1378-97,
                                                                       F 1537-94.
                                                                     ISO
                                                                       5832-3,4 & 12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       9001:1994.
----------------------------------------------------------------------------------------------------------------
\1\ National Committee for Clinical Laboratory Standards, 940 West Valley Rd., suite 1400, Wayne, PA 19087, 610-
  688-0100, http://www.nccls.org.
\2\ Centers for Disease Control and Prevention, Mail Stop G18, 1600 Clifton Rd. NE., Atlanta, GA 30333.
\3\ World Health Organization International Laboratory for Biological Standards, Statens Seruminstitut, Center
  for Prevention and Control of Infectious Diseases and Congenital Disorders, 5 Artillerivej, DK-2300 Copenhagen
  S, Denmark.
\4\ American National Standards Institute and Association for the Advancement of Medical Instrumentation, 11
  West 42d St., New York, NY 10036.
\5\ International Electrotechnical Commission, AT3, Rue de Varembe, P.O. Box 131, Geneva, Switzerland CH-1211,
  http://www.iec.ch.
\6\ American Society for Testing and Materials, Customer Services, 100 Barr Harbor Dr., West Conshohocken, PA
  19428.
\7\ International Organization for Standardization, Case Postale, Geneva, Switzerland CH-1121.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this
classification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the rule under Executive Order
12866, and the Regulatory Flexibility Act (5 U.S.C 601-612) (as amended
by subtitle D of the Small Business Regulatory Fairness Act of 1996
(Public Law 104-121), and the Unfunded Mandates Reform Act of 1995
(Public Law 104-4)). Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the final rule is not a significant regulatory action as
defined by the Executive Order and so is not subject to review under
the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of these devices from class III
will relieve all manufacturers of these devices of the cost of
complying with the premarket approval requirements in section 515 of
the act. Moreover, compliance with special controls proposed for these
devices will not impose significant new costs on affected manufacturers
as most of these devices already comply with the proposed special
controls. Because reclassification will reduce regulatory costs with
respect to these devices, it will impose no significant economic impact
on any small entities, and it may permit small potential competitors to
enter the marketplace by lowering their costs. The agency therefore
certifies that this rule will not have a significant economic impact on
a substantial number of small entities. In addition, this proposed rule
will not impose costs of $100 million or more on either the private
sector or State, local, and tribal governments in the aggregate, and
therefore a summary statement of analysis under section 202(a) of the
Unfunded Mandates Reform Act of 1995 is not required.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

[[Page 17144]]

List of Subjects

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and
containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Parts 870, 872, 874, 876, 878, 884, and 888

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
864, 866, 870, 872, 874, 876, 878, 884, 886, and 888 are amended as
follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    1. The authority citation for 21 CFR part 864 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 864.7250 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 864.7250  Erythropoietin assay.

* * * * *
    (b) Classification. Class II. The special control for this device
is FDA's ``Document for Special Controls for Erythropoietin Assay
Premarket Notification (510(k)s).''
    3. Section 864.7300 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 864.7300  Fibrin monomer paracoagulation test.

* * * * *
    (b) Classification. Class II. The special control for this device
is FDA's ``In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.''

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    4. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    5. Section 866.3510 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 866.3510  Rubella virus serological reagents.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) National Committee for Clinical Laboratory Standards':
    (i) 1/LA6 ``Detection and Quantitation of Rubella IgG Antibody:
Evaluation and Performance Criteria for Multiple Component Test
Products, Speciment Handling, and Use of the Test Products in the
Clinical Laboratory, October 1997,''
    (ii) 1/LA18 ``Specifications for Immunological Testing for
Infectious Diseases, December 1994,''
    (iii) D13 ``Agglutination Characteristics, Methodology,
Limitations, and Clinical Validation, October 1993,''
    (iv) EP5 ``Evaluation of Precision Performance of Clinical
Chemistry Devices, February 1999,'' and
    (v) EP10 ``Preliminary Evaluation of the Linearity of Quantitive
Clinical Laboratory Methods, May 1998,''
    (2) Centers for Disease Control's:
    (i) Low Titer Rubella Standard,
    (ii) Reference Panel of Well Characterized Rubella Sera, and
    (3) World Health Organization's International Rubella Standard.

PART 870--CARDIOVASCULAR DEVICES

    6. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    7. Section 870.3375 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 870.3375  Cardiovascular intravascular filter.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) ``Use of International Standards Organization's ISO 10993
`Biological Evaluation of Medical Devices Part I: Evaluation and
Testing,' '' and
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 2/12/90
(K90-1)'' and
    (ii) ``Guidance for Cardiovascular Intravascular Filter 510(k)
Submissions.''
    8. Section 870.5550 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 870.5550  External transcutaneous cardiac pacemaker (noninvasive).

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) ``American National Standards Institute/American Association
for Medical Instrumentation's DF-21 `Cardiac Defibrillator Devices' ''
2d ed., 1996, and
    (2) ``The maximum pulse amplitude should not exceed 200
milliamperes. The maximum pulse duration should not exceed 50
milliseconds.''

PART 872--DENTAL DEVICES

    9. The authority citation for 21 CFR part 872 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    10. Section 872.3540 is amended by revising paragraph (b)(2) and by
removing paragraph (c) to read as follows:

Sec. 872.3540  OTC denture cushion or pad.

* * * * *
    (b) * * *
    (2) Class II if the OTC denture cushion or pad is made of a
material other than wax-impregnated cotton cloth or if the intended use
of the device differs from that described in paragraph (b)(1) of this
section. The special controls for this device are FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical--Devices Part I: Evaluation and Testing,' '' and
    (ii) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated
Denture Kits.''
    11. Section 872.3560 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 872.3560  OTC denture reliner.

* * * * *
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated
Denture Kits.''
    12. Section 872.3570 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 872.3570  OTC denture repair kit.

* * * * *
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated
Denture Kits.''
    13. Section 872.3600 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 872.3600  Partially fabricated denture kit.

* * * * *

[[Page 17145]]

    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated
Denture Kits.''
    14. Section 872.6080 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 872.6080  Airbrush.

* * * * *
    (b) Classification. Class II. The special control for this device
is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-
03), Amendment 2, ``Medical Electrical Equipment--Part 1: General
Requirements for Safety.''

PART 874--EAR, NOSE, AND THROAT DEVICES

    15. The authority citation for 21 CFR part 874 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    16. Section 874.3400 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 874.3400  Tinnitus masker.

* * * * *
    (b) Classification. Class II. The special control for this device
is patient labeling regarding:
    (1) Hearing health care professional diagnosis, fitting of the
device, and followup care,
    (2) Risks,
    (3) Benefits,
    (4) Warnings for safe use, and
    (5) Specifications.
    17. Section 874.3930 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 874.3930  Tympanostomy tube with semipermeable membrane.

* * * * *
    (b) Classification. Class II. The special control for this device
is FDA's ``Tympanostomy Tubes, Submission Guidance for a 510(k).''

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    18. The authority citation for 21 CFR part 876 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    19. Section 876.4480 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 876.4480  Electrohydraulic lithotriptor.

* * * * *
    (b) Classification. Class II. The special control for this device
is FDA's ``Guidance for the Content of Premarket Notifications for
Intracorporeal Lithotripters.''
    20. Section 876.5860 is revised to read as follows:

Sec. 876.5860  High permeability hemodialysis system.

    (a) Identification. A high permeability hemodialysis system is a
device intended for use as an artificial kidney system for the
treatment of patients with renal failure, fluid overload, or toxemic
conditions by performing such therapies as hemodialysis,
hemofiltration, hemoconcentration, and hemodiafiltration. Using a
hemodialyzer with a semipermeable membrane that is more permeable to
water than the semipermeable membrane of the conventional hemodialysis
system (Sec. 876.5820), the high permeability hemodialysis system
removes toxins or excess fluid from the patient's blood using the
principles of convection (via a high ultrafiltration rate) and/or
diffusion (via a concentration gradient in dialysate). During
treatment, blood is circulated from the patient through the
hemodialyzer's blood compartment, while the dialysate solution flows
countercurrent through the dialysate compartment. In this process,
toxins and/or fluid are transferred across the membrane from the blood
to the dialysate compartment. The hemodialysis delivery machine
controls and monitors the parameters related to this processing,
including the rate at which blood and dialysate are pumped through the
system, and the rate at which fluid is removed from the patient. The
high permeability hemodialysis system consists of the following
devices:
    (1) The hemodialyzer consists of a semipermeable membrane with an
in vitro ultrafiltration coefficient (K<INF>uf</INF>) greater than 8
milliliters per hour per conventional millimeter of mercury, as
measured with bovine or expired human blood, and is used with either an
automated ultrafiltration controller or anther method of
ultrafiltration control to prevent fluid imbalance.
    (2) The hemodialysis delivery machine is similar to the
extracorporeal blood system and dialysate delivery system of the
hemodialysis system and accessories (Sec. 876.5820), with the addition
of an ultrafiltration controller and mechanisms that monitor and/or
control such parameters as fluid balance, dialysate composition, and
patient treatment parameters (e.g., blood pressure, hematocrit, urea,
etc.).
    (3) The high permeability hemodialysis system accessories include,
but are not limited to, tubing lines and various treatment related
monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood
recirculation monitors).
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Device--Part I: Evaluation and Testing,' ''
    (2) ``Guidance for the Content of 510(k)s for Conventional and High
Permeability Hemodialyzers,''
    (3) ``Guidance for Industry and CDRH Reviewers on the Content of
Premarket Notifications for Hemodialysis Delivery Systems,''
    (4) ``Guidance for the Content of Premarket Notifications for Water
Purification Components and Systems for Hemodialysis,'' and
    (5) ``Guidance for Hemodialyzer Reuse Labeling.''
    21. Section 876.5955 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 876.5955  Peritoneo-venous shunt.

* * * * *
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) Backflow specification and testing to prevent reflux of blood
into the shunt.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    22. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    23. Section 878.3610 is revised to read as follows:

Sec. 878.3610  Esophageal prosthesis.

    (a) Identification. An esophageal prosthesis is a rigid, flexible,
or expandable tubular device made of a plastic, metal, or polymeric
material that is intended to be implanted to restore the structure and/
or function of the esophagus. The metal esophageal prosthesis may be
uncovered or covered with a polymeric material. This device may also
include a device delivery system.
    (b) Classification. Class II. The special control for this device
is FDA's ``Guidance for the Content of Premarket Notification
Submissions for Esophageal and Tracheal Prostheses.''

[[Page 17146]]

    24. Section 878.3720 is revised to read as follows:

Sec. 878.3720  Tracheal prosthesis.

    (a) Identification. The tracheal prosthesis is a rigid, flexible,
or expandable tubular device made of a silicone, metal, or polymeric
material that is intended to be implanted to restore the structure and/
or function of the trachea or trachealbronchial tree. It may be
unbranched or contain one or two branches. The metal tracheal
prosthesis may be uncovered or covered with a polymeric material. This
device may also include a device delivery system.
    (b) Classification. Class II. The special control for this device
is FDA's ``Guidance for the Content of Premarket Notification
Submissions for Esophageal and Tracheal Prostheses.''

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    25. The authority citation for 21 CFR part 884 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    26. Section 884.1060 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 884.1060  Endometrial aspirator.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation,
or a recent cesarean section, and
    (3) The sampling component is covered within vagina.
    27. Section 884.1100 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 884.1100  Endometrial brush.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation,
or a recent cesarean section, and
    (3) Design and testing:
    (i) The sampling component is covered within the vagina, and
    (ii) For adherence of the bristles and brush head.
    28. Section 884.1185 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 884.1185  Endometrial washer.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Organization for Standardization's ISO
10993 `Biological Evaluation of Medical Devices--Part I: Evaluation and
Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium,
    (ii) Contraindications: Pregnancy, history of uterine perforation,
or a recent cesarean section, and
    (iii) Warning: Do not attach to a wall or any external suction, and
    (3) Design and Testing:
    (i) The sampling component is covered within the vagina, and
    (ii) Intrauterine pressure should not exceed 50 millimeters of
mercury.
    29. Section 884.4100 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 884.4100  Endoscopic electrocautery and accessories.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General
Requirements for Safety,''
    (3) American National Standards Institute/American Association for
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''
    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5
seconds after the visual endpoint (tissue blanching) is reached or
current flow ceases indicating adequate tissue destruction.
    30. Section 884.4150 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 884.4150  Bipolar endoscopic coagulator-cutter and accessories.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General
Requirements for Safety,''
    (3) American National Standards Institute/American Association for
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''
    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5
seconds after the visual endpoint (tissue blanching) is reached or
current flow ceases indicating adequate tissue destruction.

PART 886--OPHTHALMIC DEVICES

    31. The authority citation for 21 CFR part 886 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    32. Section 886.3400 is revised to read as follows:

[[Page 17147]]

Sec. 886.3400  Keratoprosthesis.

    (a) Identification. A keratoprosthesis is a device intended to
provide a transparent optical pathway through an opacified cornea,
either intraoperatively or permanently, in an eye that is not a
reasonable candidate for a corneal transplant.
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Guidance on 510(k) Submissions for Keratoprostheses.''
    33. Section 886.3920 is revised to read as follows:

Sec. 886.3920  Aqueous shunt.

    (a) Identification. An aqueous shunt is an implantable device
intended to reduce intraocular pressure in the anterior chamber of the
eye in patients with neurovascular glaucoma or with glaucoma when
medical and conventional surgical treatments have failed.
    (b) Classification. Class II. The special controls for this device
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Aqueous Shunts--510(k) Submissions.''

PART 888--ORTHOPEDIC DEVICES

    34. The authority citation for 21 CFR part 888 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    35. Section 888.3150 is revised to read as follows:

Sec. 888.3150  Elbow joint metal/polymer constrained cemented
prosthesis.

    (a) Identification. An elbow joint metal/polymer constrained
cemented prosthesis is a device intended to be implanted to replace an
elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum,
or of these alloys and of an ultra-high molecular weight polyethylene
bushing. The device prevents dislocation in more than one anatomic
plane and consists of two components that are linked together. This
generic type of device is limited to those prostheses intended for use
with bone cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing, ' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,''
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra High Molecular
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for
Marking, Packaging, and Labeling,''
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance
in Design/Development, Production, Installation, and Servicing,'' and
    (viii) ISO 14630:1997 ``Non-active Surgical Implants--General
Requirements,''
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
    (iv) F 981-93 ``Practice for Assessment of Compatibility of
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of
Material on Muscle and Bone,''
    (v) F 1044-95 ``Test Method for Shear Testing of Porous Metal
Coatings,''
    (vi) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium
Alloy Castings for Surgical Implants,''
    (vii) F 1147-95 ``Test Method for Tension Testing of Porous Metal
Coatings, '' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implants.''
    36. Section 888.3540 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 888.3540  Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Applications for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically
Locked' Modular Implant Components,'' and
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for
Marking, Packaging, and Labeling,''
    (vii) ISO 7207-2:1998 ``Implants for Surgery--Components for
Partial and Total Knee Joint Prostheses--Part 2: Articulating Surfaces
Made of Metal, Ceramic and Plastic Materials,'' and
    (viii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':

[[Page 17148]]

    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal
Coatings,''
    (vii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implants,'' and
    (viii) F 1672-95 ``Specification for Resurfacing Patellar
Prosthesis.''
    37. Section 888.3650 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 888.3650  Shoulder joint metal/polymer non-constrained cemented
prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal
Coatings,''
    (vii) F 1378-97 ``Specification for Shoulder Prosthesis,'' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implants.''
    38. Section 888.3660 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:

Sec. 888.3660  Shoulder joint metal/polymer semi-constrained cemented
prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-chromium-molybdenum casting alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-chromium-molybdenum alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal
Coatings,''
    (v) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium
Alloy Castings for Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal,''
    (vii) F 1378-97 ``Standard Specification for Shoulder Prosthesis,''
and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6
Molybdenum Alloy for Surgical Implants.''

    Dated: March 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-7779 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F