[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31123-31127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my08-57]
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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Federal Register, FDA is announcing the availability of the draft
guidance document that FDA intends will serve as the special control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
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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