[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.
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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 (Kuf ) 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 Kuf. 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 (Kuf) 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 Guidance1 Guidance2 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 (Kuf) 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