Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media, 47967-47969 [2017-22305]
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
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. 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 21 CFR 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
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.3960 to subpart D to read
as follows:
■
jstallworth on DSKBBY8HB2PROD with RULES
§ 866.3960 Nucleic acid-based device for
the amplification, detection, and
identification of microbial pathogens
directly from whole blood specimens.
(a) Identification. A nucleic acidbased device for the amplification,
detection, and identification of
microbial pathogens directly from
whole blood specimens is a qualitative
in vitro device intended for the
amplification, detection, and
identification of microbial-associated
nucleic acid sequences from patients
with suspected bloodstream infections.
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This device is intended to aid in the
diagnosis of bloodstream infection when
used in conjunction with clinical signs
and symptoms and other laboratory
findings.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include detailed
device description documentation,
including the device components,
ancillary reagents required but not
provided, and a detailed explanation of
the methodology, including primer/
probe sequence, design, and rationale
for sequence selection.
(2) Premarket notification
submissions must include detailed
documentation from the following
analytical and clinical performance
studies: Analytical sensitivity (limit of
detection), reactivity, inclusivity,
precision, reproducibility, interference,
cross reactivity, carryover, and cross
contamination.
(3) Premarket notification
submissions must include detailed
documentation from a clinical study.
The study, performed on a study
population consistent with the intended
use population, must compare the
device performance to results obtained
from well-accepted reference methods.
(4) Premarket notification
submissions must include detailed
documentation for device software,
including, but not limited to, software
applications and hardware-based
devices that incorporate software.
(5) The device labeling must include
limitations regarding the need for
culture confirmation of negative
specimens, as appropriate.
(6) A detailed explanation of the
interpretation of results and acceptance
criteria must be included in the device’s
21 CFR 809.10(b)(9) compliant labeling.
(7) Premarket notification
submissions must include details on an
end user device training program that
will be offered while marketing the
device, as appropriate.
(8) As part of the risk management
activities performed as part of your 21
CFR 820.30 design controls, you must
document an appropriate end user
device training program that will be
offered as part of your efforts to mitigate
the risk of failure to correctly operate
the instrument.
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22287 Filed 10–13–17; 8:45 am]
BILLING CODE 4164–01–P
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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.
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:
SUMMARY:
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
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
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
Identified risks
Mitigation measures/21 CFR section
jstallworth on DSKBBY8HB2PROD with RULES
False positive results (i.e., incorrect designation of plates for ‘‘Review’’ or as
‘‘Positive’’).
False negative results (i.e., failure to detect growth and incorrect designation of
plates as ‘‘Negative’’).
General controls and special controls: (1), (2), (3), (4), (5), (6), (7) (21
866.2190(b)(2); 21 CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4); 21
866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
General controls and special controls: (1), (2), (3), (4), (5), (6), (7) (21
866.2190(b)(2); 21 CFR 866.2190(b)(3); 21 CFR 866.2190(b)(4); 21
866.2190(b)(6); and 21 CFR 866.2190(b)(7)).
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
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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.
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CFR 866.2190(b)(1); 21 CFR
CFR 866.2190(b)(5); 21 CFR
CFR 866.2190(b)(1); 21 CFR
CFR 866.2190(b)(5); 21 CFR
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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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
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
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.2190 to subpart C to read
as follows:
■
jstallworth on DSKBBY8HB2PROD with RULES
§ 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
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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:
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47969
(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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2017–N–5224]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Enzyme Packed Cartridge
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the enzyme packed cartridge
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
enzyme packed cartridge’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 November 20, 2015.
FOR FURTHER INFORMATION CONTACT:
Joshua Silverstein, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring,
MD, 20993–0002, 301–796–5155,
joshua.silverstein@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
enzyme packed cartridge as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness. In
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Identified risks Mitigation measures/21 CFR section
----------------------------------------------------------------------------------------------------------------
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)).
----------------------------------------------------------------------------------------------------------------
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
[[Page 47969]]
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
