Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures, 4139-4141 [2018-01638]
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Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations
amendment that was published in the
Federal Register on July 1, 1997. The
Commission adopted revisions to forms
and schedules filed under the Securities
Act of 1933, the Securities Exchange Act
of 1934, related provisions of the
Investment Company Act of 1940 and
the Public Utility Holding Company Act
of 1935, and the Trust Indenture Act of
1939, to eliminate the portion of those
forms that requests filers who are
natural persons to furnish their Social
Security numbers. The 1997 amendment
to Form MSD inadvertently omitted the
removal of the second of two references
to Social Security numbers in the
instructions to the form.
DATES: Effective January 30, 2018.
FOR FURTHER INFORMATION CONTACT:
Brice Prince, at (202) 551–5777,
Division of Trading and Markets,
Securities and Exchange Commission,
100 F Street NE, Washington, DC 20549.
SUPPLEMENTARY INFORMATION: We are
making a technical correction to Form
MSD 1 under the Exchange Act.2
List of Subjects in 17 CFR Part 249
Reporting and recordkeeping
requirements, Securities.
Text of the Amendments
For the reasons set out above, title 17,
chapter II of the Code of Federal
Regulations is amended as follows:
PART 249—FORMS, SECURITIES
EXCHANGE ACT OF 1934
1. The general authority citation for
part 249 continues to read as follows:
■
Authority: 15 U.S.C. 78a et seq. and 7201
et seq.; 12 U.S.C. 5461 et seq.; 18 U.S.C. 1350;
Sec. 953(b), Pub. L. 111–203, 124 Stat. 1904;
Sec. 102(a)(3), Pub. L. 112–106, 126 Stat. 309
(2012); Sec. 107, Pub. L. 112–106, 126 Stat.
313 (2012), and Sec. 72001, Pub. L. 114–94,
129 Stat. 1312 (2015), unless otherwise
noted.
*
*
*
*
*
2. Amend General Instruction M to
Form MSD (referenced in § 249.1100),
by removing the text ‘‘; social security
numbers, if furnished, will be used only
to assist the Commission in identifying
applicants and, therefore, in promptly
processing applications’’ from the end
of the third sentence.
■
rmajette on DSKBCKNHB2PROD with RULES
Note: The text of Form MSD does not, and
the amendments will not, appear in the Code
of Federal Regulations.
*
*
*
*
*
1 17 CFR 249.1100, Form MSD, application for
registration as a municipal securities dealer
pursuant to rule 15Ba2–1 under the Securities
Exchange Act of 1934 or amendment to such
application.
2 15 U.S.C. 78a et seq.
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Dated: January 24, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018–01681 Filed 1–29–18; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2017–N–6285]
Medical Devices; Cardiovascular
Devices; Classification of the
Temporary Catheter for Embolic
Protection During Transcatheter
Intracardiac Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the temporary catheter for
embolic protection during transcatheter
intracardiac procedures 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 catheter for embolic
protection during transcatheter
intracardiac procedures’ 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, in part by reducing regulatory
burdens.
DATES: This order is effective January
30, 2018. The classification was
applicable on June 1, 2017.
FOR FURTHER INFORMATION CONTACT:
Sadaf Toor, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1202, Silver Spring,
MD 20993–0002, 301–796–6381,
Sadaf.Toor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
temporary catheter for embolic
protection during transcatheter
intracardiac procedures 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
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Fmt 4700
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4139
innovation, in part by reducing
regulatory burdens 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 (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
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.
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4140
Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations
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.
Although the device was automatically
within class III, the De Novo
classification is considered to be the
initial classification of the device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. 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 in order 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
On September 20, 2016, Claret
Medical, Inc., submitted a request for De
Novo classification of the Sentinel®
Cerebral Protection System. 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 June 1, 2017, FDA
issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 870.1251. We
have named the generic type of device
temporary catheter for embolic
protection during transcatheter
intracardiac procedures, and it is
identified as a single use percutaneous
catheter system that has (a) blood
filter(s) at the distal end. This device is
indicated for use while performing
transcatheter intracardiac procedures.
The device is used to filter blood in a
manner that may prevent embolic
material (thrombus/debris) from the
transcatheter intracardiac procedure
from traveling towards the cerebral
circulation.
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 CATHETER FOR EMBOLIC PROTECTION DURING TRANSCATHETER INTRACARDIAC PROCEDURES
RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Device failure leading to debris embolization and stroke or death ..........
Non-clinical performance testing, Animal testing, and Clinical performance testing.
Non-clinical performance testing, Animal testing, Clinical performance
testing, and Labeling.
Non-clinical performance testing, Animal testing, Clinical performance
testing, and Labeling.
Biocompatibility evaluation.
Sterilization validation, Shelf life testing, and Labeling.
Non-clinical performance testing, Animal testing, Clinical performance
testing, and Labeling.
Impeded or disrupted blood flow leading to peripheral ischemia ............
Device incompatibility with transcatheter intracardiac procedure device
leading to prolonged treatment time or device failure.
Adverse tissue reaction ............................................................................
Infection ....................................................................................................
Vascular injury due to device delivery, deployment, placement, or retrieval.
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. 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. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
rmajette on DSKBCKNHB2PROD with RULES
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.
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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. 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
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 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
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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
1. The authority citation for part 870
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 870.1251 to subpart B to read
as follows:
■
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Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations
rmajette on DSKBCKNHB2PROD with RULES
§ 870.1251 Temporary catheter for embolic
protection during transcatheter intracardiac
procedures.
(a) Identification. This device is a
single use percutaneous catheter system
that has (a) blood filter(s) at the distal
end. This device is indicated for use
while performing transcatheter
intracardiac procedures. The device is
used to filter blood in a manner that
may prevent embolic material
(thrombus/debris) from the transcatheter
intracardiac procedure from traveling
towards the cerebral circulation.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Simulated-use testing in a
clinically relevant bench anatomic
model to assess the following:
(A) Delivery, deployment, and
retrieval, including quantifying
deployment and retrieval forces, and
procedural time; and
(B) Device compatibility and lack of
interference with the transcatheter
intracardiac procedure and device.
(ii) Tensile strengths of joints and
components, tip flexibility, torque
strength, torque response, and kink
resistance.
(iii) Flow characteristics.
(A) The ability of the filter to not
impede blood flow.
(B) The amount of time the filter can
be deployed in position and/or retrieved
from its location without disrupting
blood flow.
(iv) Characterization and verification
of all dimensions.
(2) Animal testing must demonstrate
that the device performs as intended
under anticipated conditions of use. The
following performance characteristics
must be assessed:
(i) Delivery, deployment, and
retrieval, including quantifying
procedural time.
(ii) Device compatibility and lack of
interference with the transcatheter
intracardiac procedure and device.
(iii) Flow characteristics.
(A) The ability of the filter to not
impede blood flow.
(B) The amount of time the filter can
be deployed in position and/or retrieved
from its location without disrupting
blood flow.
(iv) Gross pathology and
histopathology assessing vascular injury
and downstream embolization.
(3) All patient contacting components
of the device must be demonstrated to
be biocompatible.
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(4) Performance data must
demonstrate the sterility of the device
components intended to be provided
sterile.
(5) Performance data must support the
shelf life of the device by demonstrating
continued sterility, package integrity,
and device functionality over the
identified shelf life.
(6) Labeling for the device must
include:
(i) Instructions for use;
(ii) Compatible transcatheter
intracardiac procedure devices;
(iii) A detailed summary of the
clinical testing conducted; and
(iv) A shelf life and storage
conditions.
(7) Clinical performance testing must
demonstrate:
(i) The ability to safely deliver,
deploy, and remove the device;
(ii) The ability of the device to filter
embolic material while not impeding
blood flow;
(iii) Secure positioning and stability
of the position throughout the
transcatheter intracardiac procedure;
and
(iv) Evaluation of all adverse events
including death, stroke, and vascular
injury.
Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01638 Filed 1–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2017–N–6598]
Medical Devices; General and Plastic
Surgery Devices; Classification of the
Surgical Smoke Precipitator
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the surgical smoke
precipitator 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 surgical smoke
precipitator’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
SUMMARY:
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4141
and effectiveness of the device. We
believe this action will also enhance
patients’ access to beneficial innovative
devices, in part by reducing regulatory
burdens.
DATES: This order is effective January
30, 2018. The classification was
applicable on December 20, 2016.
FOR FURTHER INFORMATION CONTACT:
Steven Elliott, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2565, Silver Spring,
MD 20993–0002, 301–796–5285,
steven.elliott@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
surgical smoke precipitator 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, in part by reducing
regulatory burdens 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 (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
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
E:\FR\FM\30JAR1.SGM
30JAR1
Agencies
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4139-4141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01638]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2017-N-6285]
Medical Devices; Cardiovascular Devices; Classification of the
Temporary Catheter for Embolic Protection During Transcatheter
Intracardiac Procedures
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the temporary catheter for embolic protection during transcatheter
intracardiac procedures 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 catheter for
embolic protection during transcatheter intracardiac procedures'
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, in part by reducing regulatory burdens.
DATES: This order is effective January 30, 2018. The classification was
applicable on June 1, 2017.
FOR FURTHER INFORMATION CONTACT: Sadaf Toor, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1202, Silver Spring, MD 20993-0002, 301-796-6381,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the temporary catheter for embolic
protection during transcatheter intracardiac procedures 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, in part
by reducing regulatory burdens 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 (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
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.
[[Page 4140]]
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. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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 in order 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
On September 20, 2016, Claret Medical, Inc., submitted a request
for De Novo classification of the Sentinel[supreg] Cerebral Protection
System. 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 June 1, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 870.1251. We have named
the generic type of device temporary catheter for embolic protection
during transcatheter intracardiac procedures, and it is identified as a
single use percutaneous catheter system that has (a) blood filter(s) at
the distal end. This device is indicated for use while performing
transcatheter intracardiac procedures. The device is used to filter
blood in a manner that may prevent embolic material (thrombus/debris)
from the transcatheter intracardiac procedure from traveling towards
the cerebral circulation.
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 Catheter for Embolic Protection During Transcatheter
Intracardiac Procedures Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Device failure leading to debris Non-clinical performance
embolization and stroke or death. testing, Animal testing, and
Clinical performance testing.
Impeded or disrupted blood flow leading Non-clinical performance
to peripheral ischemia. testing, Animal testing,
Clinical performance testing,
and Labeling.
Device incompatibility with Non-clinical performance
transcatheter intracardiac procedure testing, Animal testing,
device leading to prolonged treatment Clinical performance testing,
time or device failure. and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Sterilization validation, Shelf
life testing, and Labeling.
Vascular injury due to device delivery, Non-clinical performance
deployment, placement, or retrieval. testing, Animal 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. 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. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
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. 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
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 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; 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 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.1251 to subpart B to read as follows:
[[Page 4141]]
Sec. 870.1251 Temporary catheter for embolic protection during
transcatheter intracardiac procedures.
(a) Identification. This device is a single use percutaneous
catheter system that has (a) blood filter(s) at the distal end. This
device is indicated for use while performing transcatheter intracardiac
procedures. The device is used to filter blood in a manner that may
prevent embolic material (thrombus/debris) from the transcatheter
intracardiac procedure from traveling towards the cerebral circulation.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic
model to assess the following:
(A) Delivery, deployment, and retrieval, including quantifying
deployment and retrieval forces, and procedural time; and
(B) Device compatibility and lack of interference with the
transcatheter intracardiac procedure and device.
(ii) Tensile strengths of joints and components, tip flexibility,
torque strength, torque response, and kink resistance.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
(iv) Characterization and verification of all dimensions.
(2) Animal testing must demonstrate that the device performs as
intended under anticipated conditions of use. The following performance
characteristics must be assessed:
(i) Delivery, deployment, and retrieval, including quantifying
procedural time.
(ii) Device compatibility and lack of interference with the
transcatheter intracardiac procedure and device.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
(iv) Gross pathology and histopathology assessing vascular injury
and downstream embolization.
(3) All patient contacting components of the device must be
demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device
components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use;
(ii) Compatible transcatheter intracardiac procedure devices;
(iii) A detailed summary of the clinical testing conducted; and
(iv) A shelf life and storage conditions.
(7) Clinical performance testing must demonstrate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to filter embolic material while not
impeding blood flow;
(iii) Secure positioning and stability of the position throughout
the transcatheter intracardiac procedure; and
(iv) Evaluation of all adverse events including death, stroke, and
vascular injury.
Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01638 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P