Document ID: FDA-2022-N-3185-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device
Posted Date: 2022-12-28T05:00Z

[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.

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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, 
[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.
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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