[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Rules and Regulations]
[Pages 72317-72319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19736]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2024-N-3947]
Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Open Loop Fluid Therapy Recommender
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 adjunctive open loop fluid therapy recommender 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 open loop fluid therapy
recommender'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 September 5, 2024. The classification
was applicable on November 13, 2020.
FOR FURTHER INFORMATION CONTACT: Biniyam Taddese, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2544, Silver Spring, MD 20993-0002, 240-
402-6570, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the adjunctive open loop fluid
therapy recommender as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness.
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
[[Page 72318]]
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 (see also part 860, subpart D (21 CFR part 860, subpart D)).
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
510(k) process, when necessary, to market their device.
II. De Novo Classification
On June 4, 2019, FDA received Edwards Lifesciences' request for De
Novo classification of the Acumen Assisted Fluid Management (AFM)
Software Feature. 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 November 13, 2020, 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
870.5600.\1\ We have named the generic type of device adjunctive open
loop fluid therapy recommender, and it is identified as a prescription
device that uses software algorithms to analyze cardiovascular vital
signs and predict a patient's estimated response to fluid therapy. The
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 Open Loop Fluid Therapy Recommender Risks and
Mitigation Measures
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Identified risks to health Mitigation measures
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Delay in monitoring or treatment....... Software verification,
validation, and hazard
analysis; Usability
assessment; and Labeling.
Inappropriate or missed treatment due Software verification,
to over-reliance on software validation, and hazard
recommendation, which is affected by analysis; Non-clinical
algorithm or software error, or performance testing; Usability
inaccurate input from sensors or users. assessment; Clinical
performance testing; and
Labeling.
Fluid overload due to over-reliance on Software verification,
software recommendations, which are validation, and hazard
affected by algorithm or software analysis; Non-clinical
error, or inaccurate input from performance testing; Usability
sensors or users. assessment; Clinical
performance testing; and
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
[[Page 72319]]
premarket notification requirements under section 510(k) of the FD&C
Act.
At the time of classification, the adjunctive open loop fluid
therapy recommender 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 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
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. 870.5600 to subpart F to read as follows:
Sec. 870.5600 Adjunctive open loop fluid therapy recommender
(a) Identification. The adjunctive open loop fluid therapy
recommender is a prescription device that uses software algorithms to
analyze cardiovascular vital signs and predict a patient's estimated
response to fluid therapy. The 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) Clinical performance testing under anticipated conditions of
use must fulfill the following:
(i) A summary of the clinical performance testing must include the
relevant patient demographics, and any statistical techniques used for
analyzing the data;
(ii) Subjects must be representative of the intended use population
for the device. Any selection criteria or sample limitations must be
fully described and justified;
(iii) Testing must demonstrate the recommendation consistency using
the expected range of data sources and data quality encountered in the
intended patients, users, and environments; and
(iv) Testing must evaluate the relationship between algorithm
recommendations, therapeutic actions, and predicted physiological event
or status.
(2) 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 recommendation, accounting for
differences in patient condition and environment;
(iii) A description of all mitigations for user error or failure of
any subsystem components (including signal detection, signal analysis,
data display, and storage) that affect the device's recommendations;
(iv) A characterization of algorithm sensitivity to variations in
user inputs;
(v) A characterization of sensor accuracy and performance;
(vi) A description of sensor data quality control measures; and
(vii) Safeguards to reduce the possibility of fluid overload.
(3) A scientific justification for the validity of the algorithm(s)
must be provided. This justification must include non-clinical
verification and validation of the algorithm calculations and clinical
validation using an independent data set.
(4) A human factors and usability engineering assessment must be
provided.
(5) Labeling must include:
(i) A description of what the device measures, how the device
decides to issue recommendations, and the expected range of frequency
of recommendations, while accounting for differences in patient
condition and environment;
(ii) Detailed information regarding limitations of the device's
algorithm, and key assumptions made when the device issues a
recommendation;
(iii) Warnings identifying sensor acquisition factors that may
impact measurement results;
(iv) Warnings identifying user errors that affect the device's
recommendations;
(v) Detailed information regarding the expected impact of user
input errors on the device recommendations;
(vi) Guidance for interpretation of the device's recommendations,
including a description that the recommendation is adjunctive to other
physical vital sign parameters and patient information;
(vii) Description of the impact of the compatible sensor(s) on the
device's performance;
(viii) The expected performance of the device for all intended
patients, users, and environments;
(ix) Relevant characteristics of the patients studied in the
clinical validation (such as age, gender, race or ethnicity, and
patient condition) and a summary of validation results; and
(x) Description of the software safeguards that are in place to
prevent fluid overload, and description of any limitation of the
software safeguards.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19736 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P