Rule2022-03096
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
Primary source
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Published
February 14, 2022
Effective
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator 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 adjunctive predictive cardiovascular indicator'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 30 (Monday, February 14, 2022)</title>
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[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Rules and Regulations]
[Pages 8190-8192]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2021-N-0999]
Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Predictive Cardiovascular Indicator
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the adjunctive predictive cardiovascular indicator 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 adjunctive predictive cardiovascular indicator'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 February 14, 2022. The classification
was applicable on March 16, 2018.
FOR FURTHER INFORMATION CONTACT: Aneesh Deoras, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2564, Silver Spring, MD 20993-0002, 240-402-4363,
<a href="/cdn-cgi/l/email-protection#f0b19e95958398deb4959f829183b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="90d1fef5f5e3f8bed4f5ffe2f1e3d0f6f4f1bef8f8e3bef7ffe6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the adjunctive predictive
cardiovascular indicator as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, by placing the device into a
lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can
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serve as a predicate for 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 September 26, 2016, FDA received Edwards Lifesciences, LLC's
request for De Novo classification of the Acumen Hypotension Prediction
Index (HPI) Feature Software. 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 March 16, 2018, 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
870.2210.\1\ We have named the generic type of device adjunctive
predictive cardiovascular indicator, and it is identified as a
prescription device that uses software algorithms to analyze
cardiovascular vital signs and predict future cardiovascular status or
events. This device is intended for adjunctive use with other physical
vital sign parameters and patient information and is not intended to
independently direct therapy.
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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--Adjunctive Predictive Cardiovascular Indicator Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Delayed or incorrect treatment due to Software verification,
erroneous device output resulting from validation, and hazard
software malfunction or algorithm error. analysis;
Non-clinical performance
testing;
Clinical performance
testing; and Labeling.
Delayed or incorrect treatment due to user Usability assessment, and
misinterpretation or overreliance on Labeling.
indicator.
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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, adjunctive predictive cardiovascular
indicators are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 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. 870.2210 to subpart C to read as follows:
Sec. 870.2210 Adjunctive predictive cardiovascular indicator.
(a) Identification. The adjunctive predictive cardiovascular
indicator is a prescription device that uses software algorithms to
analyze cardiovascular
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vital signs and predict future cardiovascular status or events. This
device is intended for adjunctive use with other physical vital sign
parameters and patient information and is not intended to independently
direct therapy.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) A software description and the results of verification and
validation testing based on a comprehensive hazard analysis and risk
assessment must be provided, including:
(i) A full characterization of the software technical parameters,
including algorithms;
(ii) A description of the expected impact of all applicable sensor
acquisition hardware characteristics and associated hardware
specifications;
(iii) A description of sensor data quality control measures;
(iv) A description of all mitigations for user error or failure of
any subsystem components (including signal detection, signal analysis,
data display, and storage) on output accuracy;
(v) A description of the expected time to patient status or
clinical event for all expected outputs, accounting for differences in
patient condition and environment; and
(vi) The sensitivity, specificity, positive predictive value, and
negative predictive value in both percentage and number form.
(2) A scientific justification for the validity of the predictive
cardiovascular indicator algorithm(s) must be provided. This
justification must include verification of the algorithm calculations
and validation using an independent data set.
(3) A human factors and usability engineering assessment must be
provided that evaluates the risk of misinterpretation of device output.
(4) A clinical data assessment must be provided. This assessment
must fulfill the following:
(i) The assessment must include a summary of the clinical data
used, including source, patient demographics, and any techniques used
for annotating and separating the data.
(ii) The clinical data must be representative of the intended use
population for the device. Any selection criteria or sample limitations
must be fully described and justified.
(iii) The assessment must demonstrate output consistency using the
expected range of data sources and data quality encountered in the
intended use population and environment.
(iv) The assessment must evaluate how the device output correlates
with the predicted event or status.
(5) Labeling must include:
(i) A description of what the device measures and outputs to the
user;
(ii) Warnings identifying sensor acquisition factors that may
impact measurement results;
(iii) Guidance for interpretation of the measurements, including a
statement that the output is adjunctive to other physical vital sign
parameters and patient information;
(iv) A specific time or a range of times before the predicted
patient status or clinical event occurs, accounting for differences in
patient condition and environment;
(v) Key assumptions made during calculation of the output;
(vi) The type(s) of sensor data used, including specification of
compatible sensors for data acquisition;
(vii) The expected performance of the device for all intended use
populations and environments; and
(viii) Relevant characteristics of the patients studied in the
clinical validation (including age, gender, race or ethnicity, and
patient condition) and a summary of validation results.
Dated: February 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03096 Filed 2-11-22; 8:45 am]
BILLING CODE 4164-01-P
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