[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Rules and Regulations]
[Pages 8117-8119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3398]



[[Page 8117]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2012-N-0091]


Medical Devices; Cardiovascular Devices; Classification of the 
Endovascular Suturing System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
endovascular suturing system into class II (special controls). The 
Agency is classifying the device into class II (special controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This rule is effective March 15, 2012. The classification was 
effective on November 21, 2011.

FOR FURTHER INFORMATION CONTACT: Robert Gill, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1547, Silver Spring, MD, 20993-0002, 301-796-6373.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not 
in commercial distribution before May 28, 1976 (the date of enactment 
of the Medical Device Amendments of 1976), generally referred to as 
postamendments devices, are classified automatically by statute into 
class III without any FDA rulemaking process. These devices remain in 
class III and require premarket approval, unless and until the device 
is classified or reclassified into class I or II, or FDA issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), 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 
FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR 
part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the FD&C 
Act. FDA will, within 60 days of receiving this request, classify the 
device by written order. This classification will be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on November 12, 2010, classifying the EndoStapling System into 
class III, because it was not substantially equivalent to a device that 
was introduced or delivered for introduction into interstate commerce 
for commercial distribution before May 28, 1976, or a device which was 
subsequently reclassified into class I or class II. On December 10, 
2010, Aptus Endosystems, Inc. submitted a petition requesting 
classification of the EndoStapling System under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name endovascular suturing 
system, and it is identified as a medical device intended to provide 
fixation and sealing between an endovascular graft and the native 
artery. The system is comprised of the implant device and an 
endovascular delivery device used to implant the endovascular suture.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

                                Identified Risks and Proposed Mitigation Measures
----------------------------------------------------------------------------------------------------------------
               Identified risk                                  Recommended mitigation measures
----------------------------------------------------------------------------------------------------------------
Adverse tissue reaction.....................  Biocompatibility Labeling
Infection...................................  Sterility and Shelf Life Testing
Incompatibility with endograft..............  Bench testing
Migration or fracture of the endovascular     Bench testing
 suture.                                      Animal testing
                                              Clinical evaluation
Imaging Incompatibility.....................  Bench testing
                                              Labeling
Electromagnetic incompatibility.............  Electromagnetic Compatibility
                                              Labeling
Electrical safety issues....................  Electrical Safety Testing
                                              Labeling
Corrosion...................................  Bench testing
Improper deployment or inability to deploy..  Bench testing
                                              Animal testing
                                              Clinical evaluation
                                              Software validation
Failure to prevent endograft migration or     Bench testing
 Type I endoleak.                             Clinical evaluation
                                              Cadaver testing
----------------------------------------------------------------------------------------------------------------


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    FDA believes that the following special controls address the risks 
to health and provide reasonable assurance of the safety and 
effectiveness of the device: (1) The device should be demonstrated to 
be biocompatible; (2) sterility and shelf life testing should 
demonstrate the sterility of patient-contacting components and the 
shelf-life of these components; (3) non-clinical and clinical 
performance testing should demonstrate substantial equivalence in 
safety and effectiveness, including durability, compatibility, 
migration resistance, corrosion resistance, and delivery and 
deployment; (4) non-clinical testing should evaluate the compatibility 
of the device in an magnetic resonance (MR) environment; (5) 
appropriate analysis and non-clinical testing should validate 
electromagnetic compatibility (EMC) and electrical safety; (6) the 
sale, distribution, and use of the device are restricted to 
prescription use in accordance with 21 CFR 801.109 (Sec.  801.109); and 
(7) labeling must bear all information required for the safe and 
effective use of the device as outlined in Sec.  801.109(c), including 
a detailed summary of the non-clinical and clinical evaluations 
pertinent to use of the device; in addition to general controls, 
address the risks to health and provide reasonable assurance of the 
safety and effectiveness of the device. Therefore, on November 21, 
2011, FDA issued an order to the petitioner classifying the device into 
class II. FDA is codifying the classification of the device by adding 
Sec.  870.3460.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for an endovascular 
suturing system will need to comply with the special controls named in 
the regulation.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the endovascular suturing system they 
intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this 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.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 final rule is not a significant 
regulatory action under Executive Order 12866. 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 this device from class III to class II will 
relieve manufacturers of the device of the cost of complying with the 
premarket approval requirements of section 515 of the FD&C Act (21 
U.S.C. 360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs, the Agency certifies that the 
final rule 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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain state requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices. (See 
21 U.S.C. 360(k); See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); 
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). The special controls 
established by this final rule create ``requirements'' to address each 
identified risk to health presented by these specific medical devices 
under 21 U.S.C. 360(k), even though product sponsors may have 
flexibility in how they meet those requirements (See Papike v. 
Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)).

V. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to 
currently approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 32501-3520). The collections of information in 
part 807 subpart E, regarding premarket notification submissions, have 
been approved under OMB control no. 0910-0120; the collections of 
information in 21 CFR part 801, regarding labeling, have been approved 
under OMB control no. 0910-0485.

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Petition: Request for Evaluation of Automatic Class III 
Designation under Sec.  513(f)(2) of the Food, Drug, and Cosmetic 
Act from Aptus Endosystems, Inc., December 10, 2010.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 8119]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as 
follows:

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


0
2 Section 870.3460 is added to subpart D to read as follows:


Sec.  870.3460  Endovascular Suturing System.

    (a) Identification. An endovascular suturing system is a medical 
device intended to provide fixation and sealing between an endovascular 
graft and the native artery. The system is comprised of the implant 
device and an endovascular delivery device used to implant the 
endovascular suture.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device should be demonstrated to be biocompatible;
    (2) Sterility and shelf life testing should demonstrate the 
sterility of patient-contacting components and the shelf-life of these 
components;
    (3) Non-clinical and clinical performance testing should 
demonstrate substantial equivalence in safety and effectiveness, 
including durability, compatibility, migration resistance, corrosion 
resistance, and delivery and deployment;
    (4) Non-clinical testing should evaluate the compatibility of the 
device in an magnetic resonance (MR) environment;
    (5) Appropriate analysis and non-clinical testing should validate 
electromagnetic compatibility (EMC) and electrical safety;
    (6) The sale, distribution, and use of the device are restricted to 
prescription use in accordance with 21 CFR 801.109 of this chapter; and
    (7) Labeling must bear all information required for the safe and 
effective use of the device as outlined in Sec.  801.109(c) of this 
chapter, including a detailed summary of the non-clinical and clinical 
evaluations pertinent to use of the device.

    Dated: February 9, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-3398 Filed 2-13-12; 8:45 am]
BILLING CODE 4160-01-P