
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47967-47969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5714]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the Automated Image Assessment System for Microbial 
Colonies on Solid Culture Media

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the automated image assessment system for microbial colonies on solid 
culture media 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 automated image assessment system 
for microbial colonies on solid culture media'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, in part by reducing regulatory burdens.

DATES: This order is effective October 16, 2017. The classification was 
applicable on October 6, 2016.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866 
Steven.Tjoe@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the automated image assessment 
system for microbial colonies on solid culture media 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 reducing regulatory burdens 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

[[Page 47968]]

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 (the 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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 shall 
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, in part by reducing regulatory 
burdens. 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 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On December 24, 2015, Clever Culture Systems AG submitted a request 
for De Novo classification of the APAS Compact. 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 general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on October 6, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 866.2190. We have named 
the generic type of device automated image assessment system for 
microbial colonies on solid culture media, and it is identified as a 
system that is intended to assess the presence or absence of microbial 
colonies on solid microbiological culture medium, and to interpret 
their number, and phenotypic and morphologic characteristics through 
analysis of two dimensional digital images as an aid in diagnosis of 
infectious disease.
    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--Automated Image Assessment System for Microbial Colonies on Solid Culture Media Risks and Mitigation
                                                    Measures
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                         Identified risks                                Mitigation measures/21 CFR section
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False positive results (i.e., incorrect designation of plates for  General controls and special controls: (1),
 ``Review'' or as ``Positive'').                                    (2), (3), (4), (5), (6), (7) (21 CFR
                                                                    866.2190(b)(1); 21 CFR 866.2190(b)(2); 21
                                                                    CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4);
                                                                    21 CFR 866.2190(b)(5); 21 CFR
                                                                    866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
False negative results (i.e., failure to detect growth and         General controls and special controls: (1),
 incorrect designation of plates as ``Negative'').                  (2), (3), (4), (5), (6), (7) (21 CFR
                                                                    866.2190(b)(1); 21 CFR 866.2190(b)(2); 21
                                                                    CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4);
                                                                    21 CFR 866.2190(b)(5); 21 CFR
                                                                    866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
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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. In order 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

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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. 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, the collections of 
information in part 820 have been approved under OMB control number 
0910-0073, and the collections of information in 21 CFR parts 801 and 
809, regarding labeling have been approved under OMB control number 
0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, 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 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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


0
2. Add Sec.  866.2190 to subpart C to read as follows:


Sec.  866.2190  Automated image assessment system for microbial 
colonies on solid culture media.

    (a) Identification. An automated image assessment system for 
microbial colonies on solid culture media is a system that is intended 
to assess the presence or absence of microbial colonies on solid 
microbiological culture medium, and to interpret their number, and 
phenotypic and morphologic characteristics through analysis of two 
dimensional digital images as an aid in diagnosis of infectious 
disease.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include a detailed 
description of the device, including the technology employed, 
components and software modules, as well as a detailed explanation of 
the result algorithms and any expert rules that are used to assess 
colony characteristics and enumerate colonies from image capture 
through end result.
    (2) Premarket notification submissions must include detailed 
documentation of the analytical studies performed to characterize 
device performance to support the intended use, as appropriate.
    (3) Premarket notification submissions must include detailed 
documentation from clinical studies performed on a population that is 
consistent with the intended use population.
    (i) The clinical studies must establish the device performance 
based on comparison to results obtained by an acceptable reference 
method, as appropriate.
    (ii) The clinical study documentation must include the study 
protocol with a predefined statistical analysis plan and the final 
report documenting support for the Indications for Use and the results 
of the statistical analysis, as appropriate.
    (4) Premarket notification submissions must include detailed 
documentation for device software, including but not limited to 
software applications and hardware based components that incorporate 
software, and any decision-making thresholds used to generate results 
for the device. If a part of a Total Laboratory Automation System, the 
premarket notification submission must include detailed documentation 
addressing the instrument and software system integration.
    (5) Premarket notification submissions must include detailed 
documentation of appropriate instructions for use regarding the 
intended user's device quality control procedures for the instrument 
system and components, as appropriate.
    (6) The 21 CFR 809.10 compliant device labeling must include:
    (i) Detailed user instructions to mitigate the risk of failure to 
operate the instrument correctly.
    (ii) A detailed explanation of the interpretation of results and 
limitations regarding the need for review of culture plates by a 
qualified microbiologist, as appropriate.
    (iii) A summary of performance data obtained from the analytical 
studies used to support device performance, as appropriate.
    (iv) A summary of performance data obtained from clinical studies 
performed on a population that is consistent with the intended use 
population, as appropriate.
    (7) Under 21 CFR 820.30 compliant design control, device 
manufacturers must, as appropriate:
    (i) Conduct human factors/usability validation testing with the 
final version of the labeling and related materials to adequately 
mitigate the risk of failure to operate the instrument correctly.
    (ii) Document a device training program that will be offered to the 
end user to adequately mitigate the risk of failure to operate the 
instrument correctly.

    Dated: October 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22305 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P


