[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Rules and Regulations]
[Pages 70731-70733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0575]


Medical Devices; Neurological Devices; Classification of the 
Temporary Coil Embolization Assist Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the temporary coil embolization assist device into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the temporary coil embolization assist device's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices.

DATES: This order is effective December 13, 2021. The classification 
was applicable on April 24, 2019.

FOR FURTHER INFORMATION CONTACT: Xiaolin Zheng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4224, Silver Spring, MD 20993-0002, 301-796-2823, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the temporary coil embolization 
assist device as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, by placing the device into a lower device class 
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section

[[Page 70732]]

510(k) of the FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part 
807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device 
was automatically within class III, the De Novo classification is 
considered to be the initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo 
process, the device can serve as a predicate for future devices of that 
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application to market a substantially equivalent 
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). 
Instead, sponsors can use the less-burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 29, 2017, finding the 
Comaneci Embolization Assist Device not substantially equivalent to a 
predicate not subject to a premarket approval application. Thus, the 
device remained in class III in accordance with section 513(f)(1) of 
the FD&C Act when we issued the order.
    On September 28, 2017, Rapid-Medical Ltd. submitted a request for 
De Novo classification of the Comaneci Embolization Assist Device. FDA 
reviewed the request in order to classify the device under the criteria 
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on April 24, 2019, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
882.5955.\1\ We have named the generic type of device temporary coil 
embolization assist device, and it is identified as a prescription 
device intended for temporary use in the neurovasculature to 
mechanically assist in the embolization of intracranial aneurysms with 
embolic coils. The device is delivered into the neurovasculature with 
an endovascular approach. This device is not intended to be permanently 
implanted and is removed from the body when the procedure is completed.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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.

 Table 1--Temporary Coil Embolization Assist Device Risks and Mitigation
                                Measures
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            Identified risks                   Mitigation measures
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Infection..............................  Sterilization validation,
                                          Pyrogenicity testing, Shelf
                                          life testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Tissue or vessel damage:...............  Non-clinical performance
 Dissection....................   testing, Clinical performance
 Perforation...................   testing, and Labeling.
 Hemorrhage....................
 Vasospasm.....................
Thromboembolic event...................  Non-clinical performance
                                          testing, Clinical performance
                                          testing, and Labeling.
Coils ensnarement......................  Non-clinical performance
                                          testing, Clinical performance
                                          testing, and Labeling.
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    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. We encourage sponsors to consult 
with us if they wish to use a non-animal testing method they believe is 
suitable, adequate, validated, and feasible. We will consider if such 
an alternative method could be assessed for equivalency to an animal 
test method.

[[Page 70733]]

This device is subject to premarket notification requirements under 
section 510(k) of the FD&C Act.
    At the time of classification, temporary coil embolization assist 
devices are for prescription use only. Prescription devices are exempt 
from the requirement for adequate directions for use for the layperson 
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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. 3501-3521). The collections 
of information in the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' have been 
approved under OMB control number 0910-0844; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
820, regarding quality system regulation, have been approved under OMB 
control number 0910-0073; 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 882

    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 882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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


0
2. Add Sec.  882.5955 to subpart F to read as follows:


Sec.  882.5955   Temporary coil embolization assist device.

    (a) Identification. A temporary coil embolization assist device is 
a prescription device intended for temporary use in the 
neurovasculature to mechanically assist in the embolization of 
intracranial aneurysms with embolic coils. The device is delivered into 
the neurovasculature with an endovascular approach. This device is not 
intended to be permanently implanted and is removed from the body when 
the procedure is completed.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing of the device must demonstrate the 
device performs as intended for temporary use as an endovascular device 
to assist in the coil embolization of intracranial aneurysms and must 
evaluate all adverse events, including tissue or vessel damage that 
could lead to dissection, perforation, hemorrhage, or vasospasm, 
thrombo-embolic events, and coil entanglement.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Non-clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use, including:
    (i) Mechanical testing to demonstrate the device can withstand 
anticipated tensile, torsional, compressive, and tip deflection forces;
    (ii) Mechanical testing to evaluate the radial forces exerted by 
the device;
    (iii) Simulated use testing to demonstrate the device can be 
delivered to the target location in the neurovasculature and is 
compatible with embolic coils;
    (iv) Dimensional verification testing;
    (v) Radiopacity testing; and
    (vi) Performance testing to evaluate the coating integrity and 
particulates under simulated use conditions.
    (4) Animal testing under anticipated use conditions must evaluate 
all adverse events, including damage to vessels or tissues.
    (5) Performance data must support the sterility and pyrogenicity of 
the device.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (7) The labeling must include:
    (i) Instructions for use;
    (ii) A detailed summary of the device technical parameters, 
including compatible delivery catheter dimensions and device sizing 
information;
    (iii) A summary of the clinical testing results, including a 
detailed summary of the device- and procedure-related complications and 
adverse events; and
    (iv) A shelf life.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26926 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P