Rule2022-28131
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point
Primary source
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Published
December 27, 2022
Effective
December 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 247 (Tuesday, December 27, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#dd8eb5bcaab3f39bb2afafb8aea99dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="beedd6dfc9d090f8d1ccccdbcdcafed8dadf90d6d6cd90d9d1c8">[email protected]</span></a>.
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
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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)
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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
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</html>Indexed from Federal Register on December 27, 2022.
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