[Federal Register Volume 73, Number 105 (Friday, May 30, 2008)]
[Notices]
[Pages 31123-31127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-P-0924] (Formerly Docket No. 2000P-1533)


Cardiovascular Devices; Reclassification of Certain Percutaneous 
Transluminal Coronary Angioplasty Catheters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of panel recommendation.

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SUMMARY: The Food and Drug Administration (FDA) is issuing for public 
comment the recommendation of the Circulatory System Devices Panel (the 
Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty 
(PTCA) catheters, other than cutting/scoring PTCA catheters, from class 
III (premarket approval) to class II (special controls). The Panel made 
this recommendation after reviewing the reclassification petition 
submitted by Cook Group Inc. (COOK) and other publicly available 
information. FDA is also announcing for public comment its tentative 
findings based on the Panel's recommendation and other publicly 
available information. After considering any public comments on the 
Panel's recommendation 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. Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of the draft 
guidance document that FDA intends will serve as the special control 
for this device type, if it is reclassified.

DATES: Submit written or electronic comments by August 28, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-
P-0924, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously in the ADDRESSES portion of 
this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number for this document. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan or Suzanne Kaiser, 
Center for Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
4222.

SUPPLEMENTARY INFORMATION:

[[Page 31124]]

I. Background (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 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 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).
    Devices that were not in commercial distribution prior to May 28, 
1976, are generally referred to as postamendments devices, and 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 
predicate devices by means of premarket notification procedures in 
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the 
regulations (21 CFR part 807).
    Section 513(f)(3) of the act, as amended by FDAMA, 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 for the issuance of an order 
classifying the device in class I or class II. FDA's regulations in 21 
CFR 860.134 set forth the procedures for 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)(3)(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 PTCA catheter is a postamendments device classified into class 
III under section 513(f)(1) of the act. Therefore, the device cannot be 
placed in commercial distribution unless it is subject to an approved 
premarket approval application (PMA) under section 515 of the act (21 
U.S.C. 360e) or is reclassified.
    On September 21, 2000, FDA filed a petition submitted under section 
513(f)(3) of the act from COOK requesting reclassification of PTCA 
catheters from class III into class II (Ref. 1). This reclassification 
petition did not include cutting or scoring PTCA catheters. In order to 
reclassify the PTCA catheter into class II, it is necessary that the 
proposed class have sufficient regulatory controls to provide 
reasonable assurance of safety and effectiveness of the device for its 
intended use.
    The COOK petition requests reclassification of PTCA catheters from 
class III to class II when indicated for balloon dilatation of a 
hemodynamically significant coronary artery or bypass graft stenosis in 
patients evidencing coronary ischemia for the purpose of improving 
myocardial perfusion. Consistent with the act and the regulation, FDA 
referred the petition to the Panel for its recommendation on the 
requested changes in classification. FDA also asked the Panel for its 
recommendation on the reclassification of PTCA catheters when used for 
treatment of acute myocardial infarction (MI), treatment of in-stent 
restenosis (ISR) and/or post-deployment stent expansion.

III. Device Description

    The following device description for the PTCA catheter recommended 
for reclassification from III to II is based on the Panel's 
recommendations and the agency's review. The PTCA catheter is a device 
that operates on the principle of hydraulic pressurization applied 
through an inflatable balloon attached to the distal end. A PTCA 
balloon catheter has a single or double lumen shaft. The catheter 
features a balloon of appropriate compliance for the clinical 
application, constructed from a polymer. The balloon is designed to 
uniformly expand to a specified diameter and length at a specific 
pressure as labeled, with well characterized rates of inflation and 
deflation and a defined burst pressure. The device generally features a 
type of radiographic marker to facilitate fluoroscopic visualization of 
the balloon during use. A PTCA catheter is intended for balloon 
dilatation of a hemodynamically significant coronary artery or bypass 
graft stenosis in patients evidencing coronary ischemia for the purpose 
of improving myocardial perfusion. A PTCA catheter may also be intended 
for the treatment of acute myocardial infarction; treatment of in-stent 
restenosis (ISR) and/or post-deployment stent expansion.
    This notice of panel recommendation does not include cutting/
scoring PTCA catheters. A cutting/scoring PTCA catheter is a balloon-
tipped catheter with cutting/scoring elements attached, which is used 
in those circumstances where a high pressure balloon resistant lesion 
is encountered. A cutting/scoring PTCA catheter is intended for the 
treatment of hemodynamically significant coronary artery stenosis for 
the purpose of improving myocardial perfusion. A cutting/scoring PTCA 
catheter may also be indicated for use in complex type C lesions or for 
the treatment of in-stent restenosis.

IV. Recommendation of the Panel

    At a public meeting on December 4, 2000, the Panel recommended 
(seven to one) that PTCA catheters be reclassified from class III to 
class II, when indicated for balloon dilatation of a hemodynamically 
significant coronary artery or bypass graft stenosis in patients 
evidencing coronary ischemia for the purpose of improving myocardial 
perfusion; or for treatment of acute myocardial infarction. The Panel 
recommended a guidance document, labeling, and postmarket surveillance 
as special controls. The Panel stated that the special controls will 
diminish some of the risks to health associated with certain PTCA 
catheters. The guidance document and labeling controls are intended to 
ensure the appropriate performance and use of the device by physicians. 
The Panel recommended postmarket surveillance as a special control to 
confirm that the other special controls being applied to these devices 
would be sufficient to ensure that there would not be an increase in 
adverse consequences to patients. In summary, the Panel believed that 
class II with special controls would provide reasonable assurance of 
the safety and effectiveness of the device.

[[Page 31125]]

V. Risks to Health

    After considering the information discussed by the Panel during the 
December 4, 2000, meeting and other publicly available information 
(Refs. 2 and 3), FDA believes that certain PTCA catheters should be 
reclassified into class II because special controls, in addition to 
general controls, can provide reasonable assurance of the safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide such assurance. Based on the 
information in the petition, the Panel's deliberations, the published 
literature, and medical device reports, FDA has identified the 
following risks to health are associated with the use of PTCA 
catheters: Adverse tissue reaction, device failure, adverse interaction 
with other devices, user error, vessel damage, and infection. The draft 
guidance document entitled ``Class II Special Controls Guidance 
Document for Certain Percutaneous Transluminal Coronary Angioplasty 
(PTCA) Catheters'' aids in mitigating the risks through recommendations 
on biocompatibility, performance and animal testing, clinical 
information, sterilization, shelf life, and labeling.

A. Adverse Tissue Reaction

    Materials used to manufacture PTCA catheters may cause adverse 
tissue reactions in the patient, such as localized cell death, 
irritation, hemolysis, complement activation, thrombus formation, and 
febrile reactions.

B. Device Failure

    Balloon burst or rupture can be caused by over-inflation of the 
balloon during the procedure, use of a defective balloon, improper 
balloon sizing, the use of improper balloon inflation medium, or tissue 
calcification. PTCA catheter shaft breakage can be caused by failure of 
the manufacturing bonds or by use of excessive force during the 
procedure. Device failure may lead to reaction to contrast agent, 
vessel damage, air embolism, stroke, aneurysm formation, need for 
emergency bypass surgery or death.

C. Adverse Interaction with Other Devices

    PTCA catheters are used with accessory devices such as introducers, 
guiding catheters, and guidewires. Use with incompatible devices may 
result in a failed PTCA procedure and adverse clinical consequences. 
Guidewire entrapment or fragmentation by a PTCA catheter may lead to 
vessel damage, acute MI, unstable angina, coronary artery spasm, or 
arrhythmias, and is usually caused by excessive tortuosity of the 
coronary vessels or a complex coronary vascular anatomy.

D. User Error

    Operator inexperience and improper use of the device are common 
contributors to failed PTCA procedures. Examples of improper use 
include over-inflation of the balloon, improper balloon sizing, 
excessively slow deflation of the balloon, use of excessive force 
during the procedure, and improper balloon delivery or retraction.
    During a PTCA procedure it is possible that air embolization may 
occur as a result of incomplete aspiration of the guiding catheter, 
balloon rupture, or insinuation of air with the PTCA catheter during 
insertion or withdrawal. Air embolization may cause a stroke.
    The risk of vascular access site complications, including 
hematomas, arteriovenous (A-V) fistulas, infections, and 
pseudoaneurysms may be the result of the use of excessive force during 
the procedure, difficulty placing the device, inadequate treatment of 
the access site following the procedure, puncture of an adjacent artery 
and vein, or inadequate aseptic techniques.

E. Vessel Damage

    Injury to the coronary vessel wall, resulting in dissection, 
perforation, or rupture, is a risk that can occur with any PTCA 
procedure. Vessel damage may be caused by balloon rupture or burst, 
perforation or rupture of the vessel with an accessory device (e.g., 
guidewire or catheter), inappropriate balloon sizing, and expansion of 
an intramural hematoma. Vessel damage may lead to acute vessel closure, 
acute MI, unstable angina, coronary artery spasm, embolization or 
fragmentation of thrombotic or atherosclerotic material, or aneurysm 
formation.

F. Infection

    Infection may be caused by contamination of the device prior to use 
or inadequate aseptic techniques.

VI. Summary of the Reasons for the Recommendation

    After considering the data and information contained in the 
petition and provided by FDA, the open discussion during the Panel 
meeting, and their knowledge of and clinical experience with the 
device, the Panel gave the following reasons in support of its 
recommendation to reclassify PTCA catheters from class III to class II, 
except when indicated for the treatment of in-stent restenosis and/or 
post-deployment stent expansion. The Panel believed that the devices 
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.
    The Panel recommended that PTCA catheters for the treatment of in-
stent restenosis and/or post-deployment stent expansion not be included 
because of a lack of sufficient information about this use. Since the 
Panel meeting, however, additional data regarding this use have become 
available and have been reviewed by the agency (see section IX of this 
document, FDA's Findings).

VII. Summary of Data Upon Which the Panel Recommendation is Based

    Based on the information discussed during the on December 4, 2000, 
Panel meeting, information presented in the reclassification petition, 
published literature, and medical device reports, the Panel believes 
there is reasonable knowledge of the benefits of the device. PTCA 
catheters provide a minimally invasive means of treating coronary 
artery disease and may be a less traumatic alternative to coronary 
artery bypass surgery in some patients.

VIII. Special Controls

    In addition to general controls, FDA believes that the draft 
guidance entitled ``Class II Special Controls Guidance Document for 
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheters,'' along with general controls, would address the risks to 
health associated with the use of the device described in section V of 
this document. The draft class II special controls guidance document 
references voluntary consensus standards and describes testing and 
labeling recommendations intended to address the Panel's concerns. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability of the draft class II special controls guidance 
document that the agency intends to use as the special control for this 
device type.
    The draft class II special controls guidance document contains 
specific recommendations with regard to device performance testing and 
other information that FDA believes should be included in premarket 
(510(k)) notification submissions for PTCA catheters. Particular 
sections of the draft guidance document address the following topics: 
Biocompatibility testing, performance testing, animal testing, clinical 
information, labeling, sterilization, and sterilization and shelf life.

[[Page 31126]]

    In Table 1 of this document, FDA has identified the risks to health 
associated with the use of the device in the first column and the 
recommended mitigation measures identified in the class II special 
controls guidance document in the second column. These recommendations 
will also help ensure that the device has appropriate performance 
characteristics and labeling for its use.
    Following the effective date of any final reclassification rule 
based on this proposal, any firm submitting a 510(k) submission for a 
PTCA catheter will need to address the issues covered in the class II 
special controls guidance document. However, the firm need only show 
that its device meets the recommendations of the class II special 
controls guidance document or in some other way provides equivalent 
assurances of safety and effectiveness.

                                Table 1.
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       Identified Risk              Recommended Mitigation Measures
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Adverse Tissue Reaction        Biocompatibility Testing
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Device Failure                 Performance Testing
                               Sterilization and Shelf Life
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Adverse Interaction With       Performance Testing
 Other Devices                 Animal Testing
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User Error                     Animal Testing
                               Clinical Information
                               Labeling
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Vessel Damage                  Animal Testing
                               Clinical Information
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Infection                      Sterilization and Shelf Life
------------------------------------------------------------------------

IX. FDA's Findings

    The Panel and FDA believe that PTCA catheters, other than cutting/
scoring PTCA catheters, should be reclassified from class III 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.
    The Panel recommended a guidance document, labeling, and postmarket 
surveillance as special controls. Although the Panel included the 
possibility of requiring postmarket surveillance in their 
recommendation, FDA does not believe that specific postmarket 
surveillance such as device tracking or postapproval studies are needed 
for PTCA catheters. FDA believes that periodic assessment of adverse 
event reports through medical device reporting submitted to the agency 
is sufficient to address adverse effects caused by these devices and is 
the least burdensome way to gather this data for PTCA catheters. This 
practice is consistent with the manner in which these devices have been 
regulated as class III devices since the Panel meeting.
    Further, after a review of adverse event reports submitted to FDA's 
Manufacturer and User Facility Device Experience (MAUDE) Database (Ref. 
3), the agency believes that the types of risks associated with the use 
of PTCA catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion are similar enough to the risks associated 
with treatment of de novo lesions, such that the special controls 
discussed at the Panel meeting, with the addition of recommendations 
for specific nonclinical performance testing and the recommendation 
that in-stent restenosis patients be included in the clinical 
evaluation, when necessary, are adequate to control the risks to health 
for these devices.

X. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday:
    1. Petition for Reclassification of Percutaneous Transluminal 
Coronary Angioplasty (PTCA) Catheters submitted by COOK, Inc., 
Lafeyette, IN, received September 12, 2000.
    2. Transcript of the Circulatory System Devices Panel Meeting, 
December 4, 2000, vol. I, pp. 1-282.
    3. FDA's Manufacturer and User Facility Device Experience 
(MAUDE) Database is publicly accessible at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm. Enter 
product code LOX to search for reports regarding PTCA catheters.

XI. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
reclassification 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 reclassification action under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), 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 reclassification action is not a significant regulatory action as 
defined by 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. Because reclassification of the device from class 
III to class II will relieve all manufacturers of the device of the 
cost of complying with the premarket approval requirements in section 
515 of the act, the agency certifies that this reclassification action 
will not have a significant economic impact on a substantial number of 
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
state, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
reclassification action to result in any 1-year expenditure that would 
meet or exceed this amount.

XIII. Federalism

    FDA has analyzed this reclassification action in accordance with 
the principles set forth in Executive Order 13132. FDA has determined 
that the reclassification action does not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, the agency has concluded that the reclassification action 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XIV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this reclassification action 
contains no

[[Page 31127]]

collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520) is not required.
    FDA also tentatively concludes that the draft special control 
guidance document does not contain new information collection 
provisions that are subject to review and clearance by OMB under the 
PRA. Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice announcing the availability of the draft guidance document 
entitled ``Class II Special Controls Guidance Document for Certain 
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters;'' the 
notice contains an analysis of the paperwork burden for the draft 
guidance.

XV. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the name of the device and the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only at http://www.regulations.gov.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12079 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S