[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Rules and Regulations]
[Pages 79253-79255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3130]


Medical Devices; Cardiovascular Devices; Classification of the 
Adjunctive Hemodynamic Indicator With Decision Point

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, Agency, or we) is 
classifying the adjunctive hemodynamic indicator with decision point 
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 hemodynamic indicator with 
decision point'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 27, 2022. The classification 
was applicable on March 1, 2021.

FOR FURTHER INFORMATION CONTACT: Shawn Forrest, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2224, Silver Spring, MD 20993-0002, 301-796-5554, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the adjunctive hemodynamic 
indicator with decision point 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 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 April 3, 2020, FDA received Fifth Eye Inc.'s request for De Novo 
classification of the Analytic for Hemodynamic Instability. 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 1, 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

[[Page 79254]]

21 CFR 870.2220.\1\ We have named the generic type of device adjunctive 
hemodynamic indicator with decision point, and it is identified as a 
device that identifies and monitors hemodynamic condition(s) of 
interest and provides notifications at a clinically meaningful decision 
point. This device is intended to be used adjunctively along with other 
monitoring and patient information.
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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 Hemodynamic Indicator With Decision Point 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 output as a result of          validation, and hazard
 software malfunction or algorithm        analysis; Non-clinical
 error.                                   performance testing; Clinical
                                          data; and Labeling.
Delayed or incorrect treatment due to    Usability assessment, and
 user misinterpretation.                  Labeling.
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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.

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:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  870.2220 to subpart C to read as follows:


Sec.  870.2220  Adjunctive hemodynamic indicator with decision point.

    (a) Identification. An adjunctive hemodynamic indicator with 
decision point is a device that identifies and monitors hemodynamic 
condition(s) of interest and provides notifications at a clinically 
meaningful decision point. This device is intended to be used 
adjunctively along with other monitoring and patient information.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software description, verification, and validation based on 
comprehensive hazard analysis and risk assessment must be provided, 
including:
    (i) Full characterization of technical parameters of the software, 
including algorithm(s);
    (ii) Description of the expected impact of all applicable sensor 
acquisition hardware characteristics on performance and any associated 
hardware specifications;
    (iii) Specification of acceptable incoming sensor data quality 
control measures;
    (iv) Mitigation of impact of user error or failure of any subsystem 
components (signal detection and analysis, data display, and storage) 
on output accuracy; and
    (v) The sensitivity, specificity, positive predictive value, and 
negative predictive value in both percentage and number form for 
clinically meaningful pre-specified time windows consistent with the 
device output.
    (2) Scientific justification for the validity of the hemodynamic 
indicator algorithm(s) must be provided. Verification of algorithm 
calculations and validation testing of the algorithm must use an 
independent data set.
    (3) Usability assessment must be provided to demonstrate that risk 
of misinterpretation of the status indicator is appropriately 
mitigated.
    (4) Clinical data must support the intended use and include 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) Output measure(s) must be compared to an acceptable reference 
method to demonstrate that the output represents the measure(s) that 
the device provides in an accurate and reproducible manner;
    (iii) The data set must be representative of the intended use 
population for the device. Any selection criteria or limitations of the 
samples must be fully described and justified;
    (iv) Where continuous measurement variables are displayed, 
agreement of the output with the reference measure(s)

[[Page 79255]]

must be assessed across the full measurement range; and
    (v) Data must be provided within the clinical validation study or 
using equivalent datasets to demonstrate the consistency of the output 
and be representative of the range of data sources and data quality 
likely to be encountered in the intended use population and relevant 
use conditions in the intended use environment.
    (5) Labeling must include the following:
    (i) The type of sensor data used, including specification of 
compatible sensors for data acquisition, and a clear description of 
what the device measures and outputs to the user;
    (ii) Warnings identifying factors that may impact output results;
    (iii) Guidance for interpretation of the outputs, including 
warning(s) specifying adjunctive use of the measurements;
    (iv) Key assumptions made in the calculation and determination of 
measurements; and
    (v) A summary of the clinical validation data, including details of 
the patient population studied (e.g., age, gender, race/ethnicity), 
clinical study protocols, and device performance with confidence 
intervals for all intended use populations.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28131 Filed 12-23-22; 8:45 am]
BILLING CODE 4164-01-P