[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Pages 29043-29046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13470]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97P-0354]
Orthopedic Devices; Reclassification of the Shoulder Joint Metal/
Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated
Uncemented Prosthesis
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of panel recommendation.
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SUMMARY: The Food and Drug Administration (FDA) is announcing for
public comment a recommendation of the Orthopedic and Rehabilitation
Devices Panel (the Panel) to reclassify the shoulder joint metal/
polymer/metal nonconstrained or semi-constrained porous-coated
uncemented prosthesis from class III into class II. The Panel made this
recommendation after reviewing the reclassification petition submitted
by the Orthopedic Surgical Manufacturers Association (OSMA) and other
publicly available information. FDA is also announcing for public
comment its tentative findings on the Panel's recommendations. After
considering any public comments on the Panel's recommendations and
FDA's tentative findings, FDA will approve or deny the reclassification
petition by order in the form of a letter to the petitioner. FDA's
decision on the reclassification petition will be announced in the
Federal Register.
DATES: Written comments by August 26, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Theodore R. Stevens, Center for
Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2036.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the
amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the
SMDA) (Pub. L. 101-629), and the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) established a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the act (21 U.S.C. 360c) established three categories
(classes) of devices, depending on the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness. The
three categories of devices are class I (general controls), class II
(special controls), and class III (premarket approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the act,
to a predicate device that does not require premarket approval. The
agency determines whether new devices are substantially equivalent to
previously offered devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR
part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Reclassification of classified postamendments devices is governed
by section 513(f)(2) of the act. This section provides that FDA may
initiate the reclassification of a device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device may petition the Secretary of the Department of Health and
Human
[[Page 29044]]
Services (the Secretary) for the issuance of an order classifying the
device in class I or class II. FDA's regulations in Sec. 860.134 (21
CFR 860.134) set forth the procedures for the filing and review of a
petition for reclassification of such class III devices. In order to
change the classification of the device, it is necessary that the
proposed new class have sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
Under section 513(f)(2)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device classification panel.
The Panel shall make a recommendation to the Secretary respecting
approval or denial of the petition. Any such recommendation shall
contain: (1) A summary of the reasons for the recommendation, (2) a
summary of the data upon which the recommendation is based, and (3) an
identification of the risks to health (if any) presented by the device
with respect to which the petition was filed.
II. Regulatory History of the Device
The shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis intended to be
implanted to replace the shoulder joint is a postamendment device
classified into class III under section 513(f)(2) of the act.
Therefore, the device cannot be placed in commercial distribution for
implantation to replace the shoulder joint unless it is reclassified
under section 513(f)(2), or subject to an approved premarket approval
application (PMA) under section 515 of the act.
This action is taken in accordance with section 513(f)(2) of the
act and Sec. 860.134, based on information submitted in a petition for
reclassification by OSMA received on July 23, 1997, requesting
reclassification of the shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated uncemented prosthesis
from class III into class II (Ref. 1). Consistent with the act and the
regulation, FDA referred the petition to the Panel for its
recommendation on the requested changes in classification.
III. Device Description
The following device description is based on the Panel's
recommendations and the agency's review.
A shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis is a device intended to
be implanted to replace a shoulder joint. The device limits, with less
than normal anatomic constraints, translation in one or more planes. It
has no linkage across-the-joint. This generic type of device includes
prostheses that have a humeral component made of alloys such as cobalt-
chromium-molybdenum (Co-Cr-Mo) and/or titanium-aluminum-vanadium (Ti-
6Al-4V) alloys, and a glenoid resurfacing component made of ultrahigh
molecular weight polyethylene, or a combination of an articulating
ultra-high molecular weight bearing surface fixed in a metal shell made
of alloys such as Co-Cr-Mo and/or Ti-6Al-4V. The humeral component and
glenoid backing have a substrate porous coating made of, in Co-Cr-Mo
components, beads of the same alloy or commercially pure titanium
powder, and in Ti-6Al-4V components, beads or fibers of commercially
pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder.
The porous coating has a volume porosity between 30 to 70 percent, an
average pore size between 100 to 1,000 microns, interconnecting
porosity, and a porous coating thickness of 600 to 1,500 microns. This
generic type of device is designed to achieve biological fixation to
bone without the use of bone cement.
IV. Recommendation of the Panel
At a public meeting on January 12 and 13, 1998, the Panel
unanimously recommended that the shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated uncemented prosthesis
be reclassified from class III to class II. The Panel believed that
class II with the proposed special controls (FDA Recognized Consensus
Standards, Postmarket Surveillance, and FDA guidances) would reasonably
ensure the safety and effectiveness of the device.
V. Risks to Health
After considering the information in the petition, the Panel's
deliberations, the published literature, and the Medical Device
Reports, FDA has evaluated the risks to health associated with the use
of the shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis. FDA now believes that
the following are risks to health associated with use of the device:
Infection, adverse tissue reaction, pain and/or loss of function, and
revision. FDA notes that these risks to health are also associated with
the use of the cemented versions of shoulder joint prostheses.
A. Infection
Infection is a potential risk to health associated with all
surgical procedures and implanted devices, and it occurs equally in
patients implanted with cemented and uncemented shoulder joint
prostheses (Ref. 1). The best defenses against infection are
preventative measures, including selection of patients without known
local and/or systematic infection, administration of perioperative
antibiotics, implantation of a sterilized device, and strict adherence
to sterile surgical technique.
B. Adverse Tissue Reaction
Adverse tissue reaction is a potential risk to health associated
with all implanted devices (Ref. 1). If the materials used in the
manufacture of shoulder prostheses are not biocompatible, the patient
could have an adverse tissue reaction. The shoulder prosthesis
identified in this notice are made of implant materials with an
established, long history of safe use. In addition, the
biocompatiblility of porous-coated implant materials has been shown to
be comparable to those of the ``as cast'' materials.
C. Pain and/or Loss of Function
Pain and loss of shoulder function can occur with any shoulder
arthroplasty. Some of the same kinds of device-related complications
causing pain and loss of function are associated with implantation of
both cemented and uncemented shoulder prostheses. These complications
include: Early loosening due to inappropriate patient and/or device
selection; inappropriate surgical technique and/or poor bone quality;
some forms of metal and/or polyethylene wear which may cause osteolysis
(dissolution of bone); and component disassembly, fracture, and/or
failure. Dislocation and instability of the shoulder prosthesis may be
due to either inappropriate surgical technique and/or component design
or failure. However, other device-related complications resulting in
pain and/or loss of function are directly or uniquely related to the
porous coating(s) of uncemented shoulder prosthesis components. These
complications include incomplete and/or slow biological ingrowth into
the porous coating resulting in pain and dislocation/instability of the
joint and delamination of the porous coating from the prosthesis
components. Also, inadequate design and/or testing of the metal-backing
of the glenoid component of uncemented shoulder prostheses may cause
dislocation and instability which can result in pain and/or loss of
function.
[[Page 29045]]
D. Revision
The incidence of revision for uncemented shoulder prostheses is
comparable to the revision rates of cemented total shoulder
arthroplasty (Ref. 1). The major causes for revision of uncemented
shoulder prostheses are failure of the metal-backed glenoid component
or incomplete humeral fixation.
VI. Summary of the Reasons for the Recommendations
After considering the data and information contained in the
petition and provided by FDA, the open discussions during the Panel
meeting, and their personal knowledge of and clinical experience with
the device, the Panel gave the following reasons in support of its
recommendations to reclassify the generic device, the shoulder joint
metal/polymer/metal nonconstrained or semi-constrained porous-coated
uncemented prosthesis intended to replace a shoulder joint from class
III into class II. The Panel believes that the device should be
reclassified into class II because special controls, in addition to
general controls, would provide reasonable assurance of the safety and
effectiveness of the device, and there is sufficient information to
establish special controls to provide such assurance.
VII. Summary of Data Upon Which the Panel Recommendation Is Based
In addition to the potential risks to health of the shoulder joint
metal/polymer/metal nonconstrained or semi-constrained porous-coated
uncemented prosthesis described in section V of this document, there is
reasonable knowledge of the benefits of the device. Both cemented and
uncemented shoulder prostheses provide decreased pain or cessation of
pain and increased mobility and function, post-operatively resulting in
an overall improved quality of patient life. A specific benefit of the
uncemented shoulder prosthesis is the absence of risks associated with
the use of bone cement (e.g., embolism and bone cement breakdown) and
easier revision if revision should become indicated due to loosening.
VIII. Special Controls
FDA believes that the special controls identified below in this
document, in addition to general controls, are adequate to control the
identified risks to health for this device. FDA agrees with the Panel
that consensus standards and the FDA guidances are appropriate special
controls to reasonably ensure the safety and effectiveness of the
device. However, FDA disagrees with the Panel that postmarket
surveillance is a necessary or appropriate special control for this
device.
In their deliberations, the Panel stated that it was important that
adverse device outcomes should be reported to FDA. The Panel thought
that adverse device outcomes should be tracked through postmarket
surveillance. FDA agrees with the Panel that adverse device outcomes
should be reported to FDA. However, FDA believes that another
postmarket mechanism better addresses the Panel's concern that adverse
device outcomes should be reported to FDA. FDA believes that the
existing mandatory Medical Device Reporting system is the appropriate
mechanism to report such adverse events. Therefore, postmarket
surveillance is unnecessary to address the Panel's concerns, and to
reasonably ensure the safety and effectiveness of the device.
Based on the available information, FDA identified these 10
voluntary standards from the American Society for Testing and Materials
(ASTM) and 5 FDA guidance documents as the specific special controls to
reasonably ensure the safety and effectiveness of the shoulder joint
metal/polymer/metal nonconstrained or semi-constrained porous-coated
uncemented prosthesis as follows:
A. ASTM Standards:
1. ASTM F 67-95, ``Standard Specifications for Unalloyed Titanium
for Surgical Implant Applications;''
2. ASTM F 75-92, ``Standard Specification for Cast Cobalt-28
Chromium-6 Molybdenum Alloy for Surgical Implant Applications;''
3. ASTM F 136-96, ``Standard Specification for Wrought Titanium-6
Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy (R56401)) for
Surgical Implant Applications;''
4. ASTM F 648-98, ``Standard Specification for Ultra-High-
Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical
Implants;''
5. ASTM F 1044-95, ``Standard Test Method for Shear Testing of
Porous Metal Coatings;''
6. ASTM F 1147-95, ``Standard Test Method for Tension Testing of
Porous Metal Coatings;''
7. ASTM F 1160-91, ``Standard Test Method for Constant Stress
Amplitude Fatigue Testing of Porous Metal-Coated Metallic Materials;''
8. ASTM F 1377-92, ``Standard Specification for Cobalt-28 Chromium-
6 Molybdenum Powder for Coating of Orthopedic Implants;''
9. ASTM F 1378-97, ``Standard Specification for Shoulder
Prostheses;'' and
10. ASTM F 1580-95, ``Standard Specification for Titanium and
Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical
Implants.''
The ASTM standards define implant material specifications and
testing methods applicable to the shoulder joint metal/polymer/metal
nonconstrained or unconstrained uncemented prosthesis. Adherence to
these standards and comparison of the results from these standard test
methods can control the risks to health of adverse tissue reaction,
pain and/or loss of function, and revision by having the manufacturer
use surgical implant quality materials and assuring that the device has
acceptable performance through mechanical testing.
Nine of the ASTM standards are FDA recognized consensus standards.
FDA is now reviewing ASTM F1378-97, ``Standard Specification for
Shoulder Prostheses'' for inclusion in the list of FDA recognized
consensus standards. By the time this proposal is finalized as a final
rule, ASTM F1378 is expected to be an FDA recognized consensus
standard.
ASTM standards may be obtained from ASTM Customer Services, 100
Barr Harbor Dr., West Conshohocken, PA 19428 (Telephone 610-832-9585).
ASTM has a site on the world wide web at ``http://www.astm.org/''.
B. FDA Guidances:
1. ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement'' (Facts-on-
Demand # 827);
2. ``Guidance Document for Testing Non-articulating, `Mechanically
Locked' Modular Implant Components'' (Facts-on-Demand # 916);
3. ``Draft Guidance Document for the Preparation of Premarket
Notification (510(k)) Applications for Orthopedic Devices-The Basic
Elements'' (Facts-on-Demand # 832);
4. ``Use of International Standard ISO-10993, Biological Evaluation
of Medical Devices Part I: Evaluation and Testing'' (Facts-on-Demand #
164) ; and
5. ``510(k) Sterility Review Guidance--and Revision of 11/18/94
#K90-1'' (Facts-on-Demand # 361).
FDA guidance documents provide guidance on how to meet general
orthopedic device premarket notification (510(k)) requirements,
including biocompatibility testing, sterility testing, mechanical
performance testing, and physician and
[[Page 29046]]
patient labeling for the shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Use of the preclinical section of the FDA guidance documents can
control the risks to health of adverse tissue reaction, infection, pain
and/or loss of function, and revision by having manufacturers use
surgical quality implant materials, adequately test and sterilize their
devices, and provide adequate directions for use (and patient
information).
To receive a guidance via fax machine, telephone Center for Devices
and Radiological Health's (CDRH) CDRH Facts-on-Demand system at 800-
399-0381, or 301-827-0111 from a touch-tone telephone. At the first
voice prompt, press 1 to access the Division of Small Manufacturers
Assistance Fax, at the second voice prompt, press 2, and then enter the
document number followed by the pound sign (#). Then follow the
remaining voice prompts to complete your request. The guidances are
also available from the CDRH world wide web address at ``http://
www.fda.gov/cdrh''.
IX. FDA's Tentative Findings
FDA believes that the shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated uncemented prosthesis
should be reclassified into class II because special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.
X. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday:
1. Petition for Reclassification of Orthopaedic Shoulder
Prostheses submitted by the Orthopedic Surgical Manufacturers
Association, Warsaw, IN, received July 23, 1997.
2. Transcript of the Orthopedic and Rehabilitation Devices Panel
Meeting, January 12 and 13, 1998, vol. I, pp. 12 to 114.
XI. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.
XII. Analysis of Impacts
FDA has examined the impacts of the notice 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
(Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub.
L. 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 reclassification action is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the reclassification action 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 the device from class III to
class II will relieve manufacturers of the cost of complying with the
premarket approval requirements in section 515 of the act. Because
reclassification will reduce regulatory costs with respect to this
device, 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 reclassification action, if finalized, will not have a
significant economic impact on a substantial number of small entities.
In addition, this reclassification action 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.
XIII. Request for Comments
Interested persons may, on or before (insert date 90 days after
date of publication in the Federal Register), submit to the Dockets
Management Branch (address above) written comments regarding this
document. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m. Monday through Friday.
Dated: May 17, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-13470 Filed 5-27-99; 8:45 am]
BILLING CODE 4160-01-F