[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, [email protected].
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.
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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