Rule2022-28173
Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software 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 28, 2022
Effective
December 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 248 (Wednesday, December 28, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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,
<a href="/cdn-cgi/l/email-protection#531926372a7d193a133537327d3b3b207d343c25"><span class="__cf_email__" data-cfemail="266c53425f086c4f66404247084e4e5508414950">[email protected]</span></a>.
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.
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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--Interventional Cardiovascular Implant Simulation Software
Device Risks and Mitigation Measures
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Identified risks Mitigation measures
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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.
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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. 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
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