81 FR 71370 - Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

Page Range		71370-71371
FR Document		2016-25002

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.

Federal Register, Volume 81 Issue 200 (Monday, October 17, 2016)

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Rules and Regulations]
[Pages 71370-71371]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
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

71370 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Rules and Regulations

level because of your impairment or MD, 20993–0002, 240–402–6646, the device or if FDA determines that the
because of the removal of special jennifer.piselli@fda.hhs.gov. device submitted is not of ‘‘low-
conditions that took into account your SUPPLEMENTARY INFORMATION: moderate risk’’ or that general controls
impairment and permitted you to work. would be inadequate to control the risks
I. Background and special controls to mitigate the risks
* * * * *
■ 9. Amend § 416.999a by revising
In accordance with section 513(f)(1) of cannot be developed.
paragraph (a)(4)(i) and (c)(2) to read as the Federal Food, Drug, and Cosmetic In response to a request to classify a
follows: Act (the FD&C Act) (21 U.S.C. device under either procedure provided
360c(f)(1)), devices that were not in by section 513(f)(2) of the FD&C Act,
§ 416.999a Who is eligible for expedited commercial distribution before May 28, FDA shall classify the device by written
reinstatement? 1976 (the date of enactment of the order within 120 days. This
(a) * * * Medical Device Amendments of 1976), classification will be the initial
(4) * * * generally referred to as postamendments classification of the device.
(i) You are not able or become unable devices, are classified automatically by On June 25, 2015, Micro
to do substantial gainful activity statute into class III without any FDA Interventional Devices, Inc. submitted a
because of your medical condition as rulemaking process. These devices request for classification of the
determined under paragraph (c) of this remain in class III and require Permaseal Device under section
section. premarket approval unless and until the 513(f)(2) of the FD&C Act.
* * * * * device is classified or reclassified into In accordance with section 513(f)(2) of
(c) * * * class I or II, or FDA issues an order the FD&C Act, FDA reviewed the
(2) You are not able or become unable finding the device to be substantially request in order to classify the device
to do substantial gainful activity in the equivalent, in accordance with section under the criteria for classification set
month you file your request for 513(i), to a predicate device that does forth in section 513(a)(1). FDA classifies
reinstatement; and not require premarket approval. The devices into class II if general controls
* * * * * Agency determines whether new by themselves are insufficient to
[FR Doc. 2016–24873 Filed 10–14–16; 8:45 am] devices are substantially equivalent to provide reasonable assurance of safety
BILLING CODE 4191–02–P predicate devices by means of and effectiveness, but there is sufficient
premarket notification procedures in information to establish special controls
section 510(k) of the FD&C Act (21 to provide reasonable assurance of the
DEPARTMENT OF HEALTH AND U.S.C. 360(k)) and part 807 (21 CFR part safety and effectiveness of the device for
HUMAN SERVICES 807) of the regulations. its intended use. After review of the
Section 513(f)(2) of the FD&C Act, as
information submitted in the request,
Food and Drug Administration amended by section 607 of the Food and
FDA determined that the device can be
Drug Administration Safety and
classified into class II with the
21 CFR Part 870 Innovation Act (Pub. L. 112–144),
establishment of special controls. FDA
provides two procedures by which a
[Docket No. FDA–2016–N–2766] believes these special controls, in
person may request FDA to classify a
addition to general controls, will
Medical Devices; Cardiovascular device under the criteria set forth in
provide reasonable assurance of the
Devices; Classification of the Apical section 513(a)(1). Under the first
safety and effectiveness of the device.
Closure Device procedure, the person submits a
premarket notification under section Therefore, on July 27, 2016, FDA
AGENCY: Food and Drug Administration, 510(k) of the FD&C Act for a device that issued an order to the requestor
HHS. has not previously been classified and, classifying the device into class II. FDA
ACTION: Final order. within 30 days of receiving an order is codifying the classification of the
classifying the device into class III device by adding 21 CFR 870.4510.
SUMMARY: The Food and Drug under section 513(f)(1) of the FD&C Act, Following the effective date of this
Administration (FDA) is classifying the the person requests a classification final classification order, any firm
apical closure device into class II under section 513(f)(2). Under the submitting a premarket notification
(special controls). The special controls second procedure, rather than first (510(k)) for an apical closure device will
that will apply to the device are submitting a premarket notification need to comply with the special
identified in this order and will be part under section 510(k) of the FD&C Act controls named in this final
of the codified language for the apical and then a request for classification administrative order.
closure device’s classification. The under the first procedure, the person The device is assigned the generic
Agency is classifying the device into determines that there is no legally name apical closure device, and it is
class II (special controls) in order to marketed device upon which to base a identified as a prescription device
provide a reasonable assurance of safety determination of substantial consisting of a delivery system and
and effectiveness of the device. equivalence and requests a classification implant component that is used for soft
DATES: This order is effective October under section 513(f)(2) of the FD&C Act. tissue approximation of cardiac apical
17, 2016. The classification was If the person submits a request to tissue during transcatheter valve
applicable on July 27, 2016. classify the device under this second replacement procedures.
FOR FURTHER INFORMATION CONTACT: procedure, FDA may decline to FDA has identified the following risks
jstallworth on DSK7TPTVN1PROD with RULES

Jennifer Piselli, Center for Devices and undertake the classification request if to health associated specifically with
Radiological Health, Food and Drug FDA identifies a legally marketed device this type of device and the measures
Administration, 10903 New Hampshire that could provide a reasonable basis for required to mitigate these risks in table
Ave. Bldg. 66, Rm. 1561, Silver Spring, review of substantial equivalence with 1:

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Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Rules and Regulations 71371

TABLE 1—APICAL CLOSURE DEVICE RISKS AND MITIGATION MEASURES
Identified risk Mitigation measure

Infection .................................................................................................... Sterilization Validation.
Shelf Life Testing.
Labeling.
Adverse Tissue Reaction ......................................................................... Biocompatibility Evaluation.
In vivo Performance Testing.
Bleeding .................................................................................................... Non-clinical Performance Testing.
D At ventricular puncture or anchor deployment sites ....................... In vivo Performance Testing.
Labeling.
Tissue Damage ........................................................................................ Non-clinical Performance Testing.
D Apical tearing .................................................................................. In vivo Performance Testing.
D Myocardial tearing (local or diffuse) ............................................... Labeling.
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 III. Paperwork Reduction Act of 1995 (b) Classification. Class II (special
combination with the general controls, This final administrative order controls). The special controls for this
address these risks to health and establishes special controls that refer to device are:
provide reasonable assurance of the previously approved collections of (1) The patient contacting materials
safety and effectiveness. information found in other FDA must be evaluated to be biocompatible.
Apical closure devices are not safe for regulations. These collections of (2) Performance data must validate
information are subject to review by the the sterility of the patient-contacting
use except under the supervision of a
Office of Management and Budget components of the device.
practitioner licensed by law to direct the
(OMB) under the Paperwork Reduction (3) Performance data must support the
use of the device. As such, the device
Act of 1995 (44 U.S.C. 3501–3520). The shelf life of the device by demonstrating
is a prescription device and must satisfy continued sterility, package integrity,
prescription labeling requirements (see collections of information in part 807,
subpart E, regarding premarket and device functionality over the
21 CFR 801.109 Prescription devices). labeled shelf life.
notification submissions have been
Section 510(m) of the FD&C Act approved under OMB control number (4) Non-clinical performance testing
provides that FDA may exempt a class 0910–0120, and the collections of data must demonstrate that the device
II device from the premarket notification information in 21 CFR part 801, performs as intended under anticipated
requirements under section 510(k), if regarding labeling have been approved conditions of use. The following
FDA determines that premarket under OMB control number 0910–0485. performance characteristics must be
notification is not necessary to provide tested:
List of Subjects in 21 CFR Part 870 (i) Consistent and reliable implant
reasonable assurance of the safety and
effectiveness of the device. For this type Medical devices. deployment;
of device, FDA has determined that Therefore, under the Federal Food, (ii) Assessment of implant pull-out
premarket notification is necessary to Drug, and Cosmetic Act and under force; and
provide reasonable assurance of the authority delegated to the Commissioner (iii) Sheath size compatibility with
safety and effectiveness of the device. of Food and Drugs, 21 CFR part 870 is implant.
Therefore, this device type is not amended as follows: (5) In vivo evaluation of the device
exempt from premarket notification must demonstrate device performance,
PART 870—CARDIOVASCULAR including device operation resulting in
requirements. Persons who intend to
DEVICES closure of the myocardial wound.
market this type of device must submit
(6) Labeling must include the
to FDA a premarket notification, prior to ■ 1. The authority citation for part 870 following:
marketing the device, which contains is revised to read as follows: (i) Detailed information explaining
information about the apical closure Authority: 21 U.S.C. 351, 360, 360c, 360e, how the device operates;
device they intend to market. 360j, 360l, 371. (ii) Sheath size that device can
II. Analysis of Environmental Impact ■ 2. Add § 870.4510 to subpart E to read accommodate;
as follows: (iii) Identification of the minimum
The Agency has determined under 21 myocardial wall thickness to ensure
CFR 25.34(b) that this action is of a type § 870.4510 Apical closure device. optimal device function; and
jstallworth on DSK7TPTVN1PROD with RULES

that does not individually or (a) Identification. An apical closure (iv) A shelf life.
cumulatively have a significant effect on device is a prescription device
consisting of a delivery system and Dated: October 11, 2016.
the human environment. Therefore, Leslie Kux,
neither an environmental assessment implant component that is used for soft
tissue approximation of cardiac apical Associate Commissioner for Policy.
nor an environmental impact statement
is required. tissue during transcatheter valve [FR Doc. 2016–25002 Filed 10–14–16; 8:45 am]
replacement procedures. BILLING CODE 4164–01–P

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Document Created: 2016-10-15 01:52:00
Document Modified: 2016-10-15 01:52:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective October 17, 2016. The classification was applicable on July 27, 2016.
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]
FR Citation		81 FR 71370

81 FR 71370 - Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration