Rule2021-26926
Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2021
Effective
December 13, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 236 (Monday, December 13, 2021)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26926]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
<a href="/cdn-cgi/l/email-protection#df87b6beb0b3b6b1f185b7bab1b89fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="cd95a4aca2a1a4a3e397a5a8a3aa8daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Infection.............................. Sterilization validation,
Pyrogenicity testing, Shelf
life testing, and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Tissue or vessel damage:............... Non-clinical performance
<bullet> Dissection.................... testing, Clinical performance
<bullet> Perforation................... testing, and Labeling.
<bullet> Hemorrhage....................
<bullet> Vasospasm.....................
Thromboembolic event................... Non-clinical performance
testing, Clinical performance
testing, and Labeling.
Coils ensnarement...................... Non-clinical performance
testing, Clinical performance
testing, and Labeling.
------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 13, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.