Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device, 79801-79803 [2022-28173]
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TKELLEY on DSK125TN23PROD with RULES
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Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2022–N–3185]
(j) Alternative Methods of Compliance
(AMOCs)
[FR Doc. 2022–28221 Filed 12–27–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Medical Devices; Cardiovascular
Devices; Classification of the
Interventional Cardiovascular Implant
Simulation Software Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency or we) is
classifying the interventional
cardiovascular implant simulation
software 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 interventional
cardiovascular implant simulation
software 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
28, 2022. The classification was
applicable on September 8, 2021.
FOR FURTHER INFORMATION CONTACT: Judy
Ji, Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 2543, Silver Spring, MD, 20993–
0002, 301–796–6949, Judy.Ji@
fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
interventional cardiovascular implant
simulation software 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, in part 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
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79801
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 (see 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
device by means of the procedures for
premarket notification under section
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 (Pub. L. 105–115) established
the first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
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.
Although the device was automatically
placed 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
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Federal Register / Vol. 87, No. 248 / Wednesday, December 28, 2022 / Rules and Regulations
future devices of that type, including for
510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). 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 section 513(i) of
the FD&C Act, defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On May 7, 2020, FDA received FEops
NV’s request for De Novo classification
of the FEops HEARTguide. 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 September 8, 2021, 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 870.1405.1 We have named the
generic type of device interventional
cardiovascular implant simulation
software device, and it is identified as
a prescription device that provides a
computer simulation of an
interventional cardiovascular implant
device inside a patient’s cardiovascular
anatomy. It performs computational
modeling to predict the interaction of
the interventional cardiovascular
implant device with the patient-specific
anatomical environment.
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—INTERVENTIONAL CARDIOVASCULAR IMPLANT SIMULATION SOFTWARE DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Inaccurate simulation results leading to selection of suboptimal treatment plan, leading to prolonged procedure time and/or patient injury.
Software verification, validation, and hazard analysis; Computational
modeling verification and validation; Performance validation with clinical data; Labeling; and Human factors testing.
Software verification, validation, and hazard analysis; Human factors
testing; and Labeling.
Human factors testing, and Labeling.
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Delayed delivery of results due to software failure or use error, leading
to delay of treatment.
Failure to properly interpret device results leading to selection of suboptimal treatment plan, leading to prolonged procedure time and/or
patient injury.
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.
At the time of classification,
interventional cardiovascular implant
simulation software device is 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.
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
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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 21 CFR
part 860, subpart D, regarding De Novo
classification 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
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
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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
parts 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:
■
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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Federal Register / Vol. 87, No. 248 / Wednesday, December 28, 2022 / Rules and Regulations
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 870.1405 to subpart B to read
as follows:
■
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§ 870.1405 Interventional cardiovascular
implant simulation software device.
(a) Identification. An interventional
cardiovascular implant simulation
software device is a prescription device
that provides a computer simulation of
an interventional cardiovascular
implant device inside a patient’s
cardiovascular anatomy. It performs
computational modeling to predict the
interaction of the interventional
cardiovascular implant device with the
patient-specific anatomical
environment.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Software verification, validation,
and hazard analysis, with identification
of appropriate mitigations, must be
performed, including a full verification
and validation of the software according
to the predefined software
specifications.
(2) Computational modeling
verification and validation activities
must be performed to establish the
predictive capability of the device for its
indications for use.
(3) Performance validation testing
must be provided to demonstrate the
accuracy and clinical relevance of the
modeling methods for the intended
implantation simulations, including the
following:
(i) Computational modeling results
must be compared to clinical data
supporting the indications for use to
demonstrate accuracy and clinical
meaningfulness of the simulations;
(ii) Agreement between computational
modeling results and clinical data must
be assessed and demonstrated across the
full intended operating range (e.g., full
range of patient population, implant
device sizes and patient anatomic
morphologies). Any selection criteria or
limitations of the samples must be
described and justified;
(iii) Endpoints (e.g., performance
goals) and sample sizes established
must be justified as to how they were
determined and why they are clinically
meaningful; and
(iv) Validation must be performed and
controls implemented to characterize
and ensure consistency (i.e.,
repeatability and reproducibility) of
modeling outputs:
(A) Testing must be performed using
multiple qualified operators and using
the procedure that will be implemented
under anticipated conditions of use; and
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(B) The factors (e.g., medical imaging
dataset, operator) must be identified
regarding which were held constant and
which were varied during the
evaluation, and a description must be
provided for the computations and
statistical analyses used to evaluate the
data.
(4) Human factors evaluation must be
performed to evaluate the ability of the
user interface and labeling to allow for
intended users to correctly use the
device and interpret the provided
information.
(5) Device labeling must be provided
that describes the following:
(i) Warnings that identify anatomy
and image acquisition factors that may
impact simulation results and provide
cautionary guidance for interpretation of
the provided simulation results;
(ii) Device simulation inputs and
outputs, and key assumptions made in
the simulation and determination of
simulated outputs; and
(iii) The computational modeling
performance of the device for presented
simulation outputs, and the supporting
evidence for this performance.
Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–28173 Filed 12–27–22; 8:45 am]
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DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 587
Publication of Russian Harmful
Foreign Activities Sanctions
Regulations Web General Licenses 8D
and 40C
Office of Foreign Assets
Control, Treasury.
ACTION: Publication of Web General
Licenses.
AGENCY:
The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is publishing two
general licenses (GLs) issued pursuant
to the Russian Harmful Foreign
Activities Sanctions Regulations: GLs
8D and 40C, which were previously
made available on OFAC’s website.
DATES: GL 8D was issued on November
10, 2022. See SUPPLEMENTARY
INFORMATION for additional relevant
dates.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
OFAC: Assistant Director for Licensing,
202–622–2480; Assistant Director for
Regulatory Affairs, 202–622–4855; or
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79803
Assistant Director for Sanctions
Compliance & Evaluation, 202–622–
2490.
SUPPLEMENTARY INFORMATION:
Electronic Availability
This document and additional
information concerning OFAC are
available on OFAC’s website:
www.treas.gov/ofac.
Background
On November 10, 2022, OFAC issued
GL 8D to authorize certain transactions
otherwise prohibited by the Russian
Harmful Foreign Activities Sanctions
Regulations, 31 CFR part 587 (RuHSR).
On November 14, 2022, OFAC issued
GL 40C to authorize certain transactions
otherwise prohibited by the RuHSR. At
the time of issuance, OFAC made GLs
8D and 40C available on its website
(www.treas.gov/ofac). The text of these
GLs is provided below.
OFFICE OF FOREIGN ASSETS CONTROL
Russian Harmful Foreign Activities
Sanctions Regulations; 31 CFR Part 587
GENERAL LICENSE NO. 8D
Authorizing Transactions Related to Energy
(a) Except as provided in paragraph (c) of
this general license, all transactions
prohibited by Executive Order (E.O.) 14024
involving one or more of the following
entities that are related to energy are
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daylight time, May 15, 2023.
(1) State Corporation Bank for
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Financial Corporation Otkritie;
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the term ‘‘related to energy’’ means the
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Agencies
[Federal Register Volume 87, Number 248 (Wednesday, December 28, 2022)]
[Rules and Regulations]
[Pages 79801-79803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28173]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2022-N-3185]
Medical Devices; Cardiovascular Devices; Classification of the
Interventional Cardiovascular Implant Simulation Software Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency or we) is
classifying the interventional cardiovascular implant simulation
software 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 interventional cardiovascular
implant simulation software 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 28, 2022. The classification
was applicable on September 8, 2021.
FOR FURTHER INFORMATION CONTACT: Judy Ji, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2543, Silver Spring, MD, 20993-0002, 301-796-6949,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the interventional cardiovascular
implant simulation software 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, in part 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 (see 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 device by means of
the procedures for premarket notification under section 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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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. Although the device was automatically placed
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
[[Page 79802]]
future devices of that type, including for 510(k)s (see section
513(f)(2)(B)(i) of the FD&C Act). 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 section 513(i) of the
FD&C Act, defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.
II. De Novo Classification
On May 7, 2020, FDA received FEops NV's request for De Novo
classification of the FEops HEARTguide. 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 September 8, 2021, 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
870.1405.\1\ We have named the generic type of device interventional
cardiovascular implant simulation software device, and it is identified
as a prescription device that provides a computer simulation of an
interventional cardiovascular implant device inside a patient's
cardiovascular anatomy. It performs computational modeling to predict
the interaction of the interventional cardiovascular implant device
with the patient-specific anatomical environment.
---------------------------------------------------------------------------
\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--Interventional Cardiovascular Implant Simulation Software
Device Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Inaccurate simulation results leading Software verification,
to selection of suboptimal treatment validation, and hazard
plan, leading to prolonged procedure analysis; Computational
time and/or patient injury. modeling verification and
validation; Performance
validation with clinical data;
Labeling; and Human factors
testing.
Delayed delivery of results due to Software verification,
software failure or use error, leading validation, and hazard
to delay of treatment. analysis; Human factors
testing; and Labeling.
Failure to properly interpret device Human factors testing, and
results leading to selection of Labeling.
suboptimal treatment plan, leading to
prolonged procedure time and/or
patient injury.
------------------------------------------------------------------------
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.
At the time of classification, interventional cardiovascular
implant simulation software device is 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 21 CFR part 860, subpart D, regarding De Novo
classification 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 parts 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:
[[Page 79803]]
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.1405 to subpart B to read as follows:
Sec. 870.1405 Interventional cardiovascular implant simulation
software device.
(a) Identification. An interventional cardiovascular implant
simulation software device is a prescription device that provides a
computer simulation of an interventional cardiovascular implant device
inside a patient's cardiovascular anatomy. It performs computational
modeling to predict the interaction of the interventional
cardiovascular implant device with the patient-specific anatomical
environment.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Software verification, validation, and hazard analysis, with
identification of appropriate mitigations, must be performed, including
a full verification and validation of the software according to the
predefined software specifications.
(2) Computational modeling verification and validation activities
must be performed to establish the predictive capability of the device
for its indications for use.
(3) Performance validation testing must be provided to demonstrate
the accuracy and clinical relevance of the modeling methods for the
intended implantation simulations, including the following:
(i) Computational modeling results must be compared to clinical
data supporting the indications for use to demonstrate accuracy and
clinical meaningfulness of the simulations;
(ii) Agreement between computational modeling results and clinical
data must be assessed and demonstrated across the full intended
operating range (e.g., full range of patient population, implant device
sizes and patient anatomic morphologies). Any selection criteria or
limitations of the samples must be described and justified;
(iii) Endpoints (e.g., performance goals) and sample sizes
established must be justified as to how they were determined and why
they are clinically meaningful; and
(iv) Validation must be performed and controls implemented to
characterize and ensure consistency (i.e., repeatability and
reproducibility) of modeling outputs:
(A) Testing must be performed using multiple qualified operators
and using the procedure that will be implemented under anticipated
conditions of use; and
(B) The factors (e.g., medical imaging dataset, operator) must be
identified regarding which were held constant and which were varied
during the evaluation, and a description must be provided for the
computations and statistical analyses used to evaluate the data.
(4) Human factors evaluation must be performed to evaluate the
ability of the user interface and labeling to allow for intended users
to correctly use the device and interpret the provided information.
(5) Device labeling must be provided that describes the following:
(i) Warnings that identify anatomy and image acquisition factors
that may impact simulation results and provide cautionary guidance for
interpretation of the provided simulation results;
(ii) Device simulation inputs and outputs, and key assumptions made
in the simulation and determination of simulated outputs; and
(iii) The computational modeling performance of the device for
presented simulation outputs, and the supporting evidence for this
performance.
Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28173 Filed 12-27-22; 8:45 am]
BILLING CODE 4164-01-P