Document ID: FDA-2016-N-2766-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
Posted Date: 2016-10-17T04:00Z

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Rules and Regulations]
[Pages 71370-71371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25002]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2016-N-2766]

Medical Devices; Cardiovascular Devices; Classification of the 
Apical Closure Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
apical closure device into class II (special controls). The special 
controls that will apply to the device are identified in this order and 
will be part of the codified language for the apical closure device's 
classification. 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 order is effective October 17, 2016. The classification was 
applicable on July 27, 2016.

FOR FURTHER INFORMATION CONTACT: Jennifer Piselli, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 66, Rm. 1561, Silver Spring, MD, 20993-0002, 240-
402-6646, jennifer.piselli@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the 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), 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 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On June 25, 2015, Micro Interventional Devices, Inc. submitted a 
request for classification of the Permaseal Device under section 
513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). 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 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on July 27, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 870.4510.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an apical 
closure device will need to comply with the special controls named in 
this final administrative order.
    The device is assigned the generic name apical closure device, and 
it is identified as a prescription device consisting of a delivery 
system and implant component that is used for soft tissue approximation 
of cardiac apical tissue during transcatheter valve replacement 
procedures.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1:

[[Page 71371]]

      Table 1--Apical Closure Device Risks and Mitigation Measures
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            Identified risk                     Mitigation measure
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Infection..............................  Sterilization Validation.
                                         Shelf Life Testing.
                                         Labeling.
Adverse Tissue Reaction................  Biocompatibility Evaluation.
                                         In vivo Performance Testing.
Bleeding...............................  Non-clinical Performance
                                          Testing.
    [ssquf] At ventricular puncture or   In vivo Performance Testing.
     anchor deployment sites.            Labeling.
Tissue Damage..........................  Non-clinical Performance
                                          Testing.
    [ssquf] Apical tearing.............  In vivo Performance Testing.
    [ssquf] Myocardial tearing (local    Labeling.
     or diffuse).                        Training.
New Hypokinesia or Akinesis of Apex....  In vivo Performance Testing.
                                         Labeling.
Thromboemboli and Full Thickness Injury  In vivo Performance Testing.
                                         Labeling.
                                         Training.
Pericardial Tamponade..................  In vivo Performance Testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Apical closure devices are not safe for use except under the 
supervision of a practitioner licensed by law to direct the use of the 
device. As such, the device is a prescription device and must satisfy 
prescription labeling requirements (see 21 CFR 801.109 Prescription 
devices).
    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), 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 
apical closure device they intend to market.

II. Analysis of 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. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously 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. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120, and 
the collections of information in 21 CFR part 801, regarding labeling 
have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
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 part 870 is revised to read as follows:

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

0
2. Add Sec.  870.4510 to subpart E to read as follows:

Sec.  870.4510  Apical closure device.

    (a) Identification. An apical closure device is a prescription 
device consisting of a delivery system and implant component that is 
used for soft tissue approximation of cardiac apical tissue during 
transcatheter valve replacement procedures.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be evaluated to be 
biocompatible.
    (2) Performance data must validate the sterility of the patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (4) Non-clinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Consistent and reliable implant deployment;
    (ii) Assessment of implant pull-out force; and
    (iii) Sheath size compatibility with implant.
    (5) In vivo evaluation of the device must demonstrate device 
performance, including device operation resulting in closure of the 
myocardial wound.
    (6) Labeling must include the following:
    (i) Detailed information explaining how the device operates;
    (ii) Sheath size that device can accommodate;
    (iii) Identification of the minimum myocardial wall thickness to 
ensure optimal device function; and
    (iv) A shelf life.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25002 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P