
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35065-35067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-1620]


Medical Devices; Cardiovascular Devices; Classification of the 
Adjunctive Cardiovascular Status Indicator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
adjunctive cardiovascular status indicator into class II (special 
controls). The special controls that will apply to the device are 
identified in this order and will be part of the codified language for 
the adjunctive cardiovascular status indicator's classification. The 
Agency is classifying the device into class II (special controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This order is effective July 28, 2017. The classification was 
applicable on December 21, 2016.

FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-
796-1235, nathalie.yarkony@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval unless and until the device 
is classified or reclassified into class I or II, or FDA issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i) of the FD&C Act, to a predicate device that does 
not require premarket approval. The Agency determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

[[Page 35066]]

    Section 513(f)(2) of the FD&C Act, also known as De Novo 
classification, as amended by section 607 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), provides 
two procedures by which a person may request FDA to classify a device 
under the criteria set forth in section 513(a)(1). Under the first 
procedure, the person submits a premarket notification under section 
510(k) of the FD&C Act for a device that has not previously been 
classified and, within 30 days of receiving an order classifying the 
device into class III under section 513(f)(1) of the FD&C Act, the 
person requests a classification under section 513(f)(2). Under the 
second procedure, rather than first submitting a premarket notification 
under section 510(k) of the FD&C Act and then a request for 
classification under the first procedure, the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence and requests a classification under section 
513(f)(2) of the FD&C Act. If the person submits a request to classify 
the device under this second procedure, FDA may decline to undertake 
the classification request if FDA identifies a legally marketed device 
that could provide a reasonable basis for review of substantial 
equivalence with the device or if FDA determines that the device 
submitted is not of ``low-moderate risk'' or that general controls 
would be inadequate to control the risks and special controls to 
mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On May 24, 2016, Flashback Technologies submitted a request for 
classification of the CipherOx CRI Tablet under section 513(f)(2) of 
the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies 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 to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on December 21, 2016, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  870.2200.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an adjunctive 
cardiovascular status indicator will need to comply with the special 
controls named in this final order. A De Novo classification decreases 
regulatory burdens. When FDA classifies a device type as class I or II 
via the De Novo pathway, other manufacturers do not have to submit a De 
Novo request or premarket approval application in order to market the 
same type of device, unless the device has a new intended use or 
technological characteristics that raise different questions of safety 
or effectiveness. Instead, manufacturers can use the less burdensome 
510(k) pathway, when necessary, to market their device, and the device 
that was the subject of the original De Novo classification can serve 
as a predicate device for additional 510(k)s from other manufacturers.
    The device is assigned the generic name adjunctive cardiovascular 
status indicator, and it is identified as a prescription device based 
on sensor technology for the measurement of a physical parameter(s). 
This device is intended for adjunctive use with other physical vital 
sign parameters and patient information and is not intended to 
independently direct therapy.
    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 Cardiovascular Status Indicator Risks and Mitigation Measures
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           Identified risk                                        Mitigation measures
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Delayed or incorrect treatment due    Software verification, validation, and hazard analysis.
 to erroneous output as a result of   Non-clinical performance testing.
 software malfunction or algorithm    Clinical performance testing.
 error.                               Labeling.
Delayed or incorrect treatment due    Usability assessment.
 to user misinterpretation.           Labeling.
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    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Adjunctive cardiovascular status indicators are not safe for use 
except under the supervision of a practitioner licensed by law to 
direct the use of the device. As such, the device is a prescription 
device and must satisfy prescription labeling requirements (see 21 CFR 
801.109 Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k), if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA believes premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device type and, therefore, is planning to exempt 
the device from the premarket notification requirements under section 
510(m) of the FD&C Act. Once finalized, persons who intend to market 
this device type need not submit a 510(k) premarket notification 
containing information on the adjunctive cardiovascular status 
indicator prior to marketing the device.

II. 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.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of

[[Page 35067]]

information found in other FDA regulations. 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-
3520). The collections of information in part 807, subpart E, regarding 
premarket notification submissions have been approved under OMB control 
number 0910-0120, 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.  870.2200 to subpart C to read as follows:


Sec.  870.2200  Adjunctive cardiovascular status indicator.

    (a) Identification. The adjunctive cardiovascular status indicator 
is a prescription device based on sensor technology for the measurement 
of a physical parameter(s). 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) Software description, verification, and validation based on 
comprehensive hazard analysis must be provided, including:
    (i) Full characterization of technical parameters of the software, 
including any proprietary 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; and
    (iv) Mitigation of impact of user error or failure of any subsystem 
components (signal detection and analysis, data display, and storage) 
on accuracy of patient reports.
    (2) Scientific justification for the validity of the status 
indicator algorithm(s) must be provided. Verification of algorithm 
calculations and validation testing of the algorithm using a data set 
separate from the training data must demonstrate the validity of 
modeling.
    (3) Usability assessment must be provided to demonstrate that risk 
of misinterpretation of the status indicator is appropriately 
mitigated.
    (4) Clinical data must be provided in support of the intended use 
and include the following:
    (i) Output measure(s) must be compared to an acceptable reference 
method to demonstrate that the output measure(s) represent(s) the 
predictive measure(s) that the device provides in an accurate and 
reproducible manner;
    (ii) 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;
    (iii) Agreement of the measure(s) with the reference measure(s) 
must be assessed across the full measurement range; and
    (iv) 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;
    (ii) A description of what the device measures and outputs to the 
user;
    (iii) Warnings identifying sensor reading acquisition factors that 
may impact measurement results;
    (iv) Guidance for interpretation of the measurements, including 
warning(s) specifying adjunctive use of the measurements;
    (v) Key assumptions made in the calculation and determination of 
measurements;
    (vi) The measurement performance of the device for all presented 
parameters, with appropriate confidence intervals, and the supporting 
evidence for this performance; and
    (vii) A detailed description of the patients studied in the 
clinical validation (e.g., age, gender, race/ethnicity, clinical 
stability) as well as procedural details of the clinical study.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15901 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P


