82 FR 47967 - Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 198 (October 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 47967-47969 | |
| FR Document | 2017-22305 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Rules and Regulations] [Pages 47967-47969] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47967
subject to premarket notification This device is intended to aid in the DEPARTMENT OF HEALTH AND
requirements under section 510(k) of the diagnosis of bloodstream infection when HUMAN SERVICES
FD&C Act. used in conjunction with clinical signs
and symptoms and other laboratory Food and Drug Administration
III. Analysis of Environmental Impact
findings.
The Agency has determined under 21 (b) Classification. Class II (special 21 CFR Part 866
CFR 25.34(b) that this action is of a type controls). The special controls for this [Docket No. FDA–2017–N–5714]
that does not individually or device are:
cumulatively have a significant effect on (1) Premarket notification Medical Devices; Immunology and
the human environment. Therefore, submissions must include detailed Microbiology Devices; Classification of
neither an environmental assessment device description documentation, the Automated Image Assessment
nor an environmental impact statement including the device components, System for Microbial Colonies on Solid
is required. ancillary reagents required but not Culture Media
IV. Paperwork Reduction Act of 1995 provided, and a detailed explanation of
the methodology, including primer/ AGENCY: Food and Drug Administration,
This final order establishes special HHS.
probe sequence, design, and rationale
controls that refer to previously ACTION: Final order.
for sequence selection.
approved collections of information
found in other FDA regulations. These (2) Premarket notification
SUMMARY: The Food and Drug
collections of information are subject to submissions must include detailed
Administration (FDA or we) is
review by the Office of Management and documentation from the following
classifying the automated image
Budget (OMB) under the Paperwork analytical and clinical performance
assessment system for microbial
Reduction Act of 1995 (44 U.S.C. 3501– studies: Analytical sensitivity (limit of
colonies on solid culture media into
3520). The collections of information in detection), reactivity, inclusivity,
class II (special controls). The special
part 807, subpart E, regarding premarket precision, reproducibility, interference,
controls that apply to the device type
notification submissions have been cross reactivity, carryover, and cross
are identified in this order and will be
approved under OMB control number contamination.
part of the codified language for the
0910–0120, the collections of (3) Premarket notification automated image assessment system for
information in 21 CFR part 820 have submissions must include detailed microbial colonies on solid culture
been approved under OMB control documentation from a clinical study. media’s classification. We are taking
number 0910–0073, and the collections The study, performed on a study this action because we have determined
of information in 21 CFR parts 801 and population consistent with the intended that classifying the device into class II
809, regarding labeling have been use population, must compare the (special controls) will provide a
approved under OMB control number device performance to results obtained reasonable assurance of safety and
0910–0485. from well-accepted reference methods. effectiveness of the device. We believe
(4) Premarket notification this action will also enhance patients’
List of Subjects in 21 CFR Part 866 submissions must include detailed access to beneficial innovative devices,
Biologics, Laboratories, Medical documentation for device software, in part by reducing regulatory burdens.
devices. including, but not limited to, software
DATES: This order is effective October
Therefore, under the Federal Food, applications and hardware-based
devices that incorporate software. 16, 2017. The classification was
Drug, and Cosmetic Act and under applicable on October 6, 2016.
authority delegated to the Commissioner (5) The device labeling must include
limitations regarding the need for FOR FURTHER INFORMATION CONTACT:
of Food and Drugs, 21 CFR part 866 is
amended as follows: culture confirmation of negative Steven Tjoe, Center for Devices and
specimens, as appropriate. Radiological Health, Food and Drug
PART 866—IMMUNOLOGY AND (6) A detailed explanation of the Administration, 10903 New Hampshire
MICROBIOLOGY DEVICES interpretation of results and acceptance Ave., Bldg. 66, Rm. 4550, Silver Spring,
criteria must be included in the device’s MD 20993–0002, 301–796–5866
■ 1. The authority citation for part 866 21 CFR 809.10(b)(9) compliant labeling. Steven.Tjoe@fda.hhs.gov.
continues to read as follows: SUPPLEMENTARY INFORMATION:
(7) Premarket notification
Authority: 21 U.S.C. 351, 360, 360c, 360e, submissions must include details on an I. Background
360j, 360l, 371. end user device training program that
will be offered while marketing the Upon request, FDA has classified the
■ 2. Add § 866.3960 to subpart D to read automated image assessment system for
as follows: device, as appropriate.
(8) As part of the risk management microbial colonies on solid culture
§ 866.3960 Nucleic acid-based device for activities performed as part of your 21 media as class II (special controls),
the amplification, detection, and CFR 820.30 design controls, you must which we have determined will provide
identification of microbial pathogens
document an appropriate end user a reasonable assurance of safety and
directly from whole blood specimens. effectiveness. In addition, we believe
device training program that will be
(a) Identification. A nucleic acid- offered as part of your efforts to mitigate this action will enhance patients’ access
based device for the amplification, the risk of failure to correctly operate to beneficial innovation, in part by
detection, and identification of the instrument. reducing regulatory burdens by placing
jstallworth on DSKBBY8HB2PROD with RULES
microbial pathogens directly from the device into a lower device class than
whole blood specimens is a qualitative Dated: October 10, 2017. the automatic class III assignment.
in vitro device intended for the Anna K. Abram, The automatic assignment of class III
amplification, detection, and Deputy Commissioner for Policy, Planning, occurs by operation of law and without
identification of microbial-associated Legislation, and Analysis. any action by FDA, regardless of the
nucleic acid sequences from patients [FR Doc. 2017–22287 Filed 10–13–17; 8:45 am] level of risk posed by the new device.
with suspected bloodstream infections. BILLING CODE 4164–01–P Any device that was not in commercial
VerDate Sep<11>2014 14:58 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\16OCR1.SGM 16OCR1](https://thefederalregister.org/doc/82_FR_48165/page/1.svg)
![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47969
nor an environmental impact statement colony characteristics and enumerate (i) Conduct human factors/usability
is required. colonies from image capture through validation testing with the final version
end result. of the labeling and related materials to
IV. Paperwork Reduction Act of 1995 (2) Premarket notification adequately mitigate the risk of failure to
This final order establishes special submissions must include detailed operate the instrument correctly.
controls that refer to previously documentation of the analytical studies (ii) Document a device training
approved collections of information performed to characterize device program that will be offered to the end
found in other FDA regulations. These performance to support the intended user to adequately mitigate the risk of
collections of information are subject to use, as appropriate. failure to operate the instrument
review by the Office of Management and (3) Premarket notification correctly.
Budget (OMB) under the Paperwork submissions must include detailed Dated: October 11, 2017.
Reduction Act of 1995 (44 U.S.C. 3501– documentation from clinical studies
Leslie Kux,
3520). The collections of information in performed on a population that is
part 807, subpart E, regarding premarket Associate Commissioner for Policy.
consistent with the intended use
notification submissions have been population. [FR Doc. 2017–22305 Filed 10–13–17; 8:45 am]
approved under OMB control number (i) The clinical studies must establish BILLING CODE 4164–01–P
0910–0120, the collections of the device performance based on
information in part 820 have been comparison to results obtained by an
approved under OMB control number acceptable reference method, as DEPARTMENT OF HEALTH AND
0910–0073, and the collections of appropriate. HUMAN SERVICES
information in 21 CFR parts 801 and (ii) The clinical study documentation
must include the study protocol with a Food and Drug Administration
809, regarding labeling have been
approved under OMB control number predefined statistical analysis plan and
the final report documenting support for 21 CFR Part 876
0910–0485.
the Indications for Use and the results [Docket No. FDA–2017–N–5224]
List of Subjects in 21 CFR Part 866 of the statistical analysis, as appropriate.
Biologics, Laboratories, Medical (4) Premarket notification Medical Devices; Gastroenterology-
devices. submissions must include detailed Urology Devices; Classification of the
Therefore, under the Federal Food, documentation for device software, Enzyme Packed Cartridge
Drug, and Cosmetic Act and under including but not limited to software AGENCY: Food and Drug Administration,
authority delegated to the Commissioner applications and hardware based HHS.
of Food and Drugs, 21 CFR part 866 is components that incorporate software,
and any decision-making thresholds ACTION: Final order.
amended as follows:
used to generate results for the device. SUMMARY: The Food and Drug
PART 866—IMMUNOLOGY AND If a part of a Total Laboratory Administration (FDA or we) is
MICROBIOLOGY DEVICES Automation System, the premarket classifying the enzyme packed cartridge
notification submission must include into class II (special controls). The
■ 1. The authority citation for part 866 detailed documentation addressing the
continues to read as follows: special controls that apply to the device
instrument and software system type are identified in this order and will
Authority: 21 U.S.C. 351, 360, 360c, 360e, integration. be part of the codified language for the
360j, 360l, 371. (5) Premarket notification enzyme packed cartridge’s
■ 2. Add § 866.2190 to subpart C to read submissions must include detailed classification. We are taking this action
as follows: documentation of appropriate because we have determined that
instructions for use regarding the classifying the device into class II
§ 866.2190 Automated image assessment intended user’s device quality control
system for microbial colonies on solid
(special controls) will provide a
procedures for the instrument system reasonable assurance of safety and
culture media. and components, as appropriate.
(a) Identification. An automated effectiveness of the device. We believe
(6) The 21 CFR 809.10 compliant this action will also enhance patients’
image assessment system for microbial device labeling must include:
colonies on solid culture media is a access to beneficial innovative devices,
(i) Detailed user instructions to
system that is intended to assess the in part by reducing regulatory burdens.
mitigate the risk of failure to operate the
presence or absence of microbial DATES: This order is effective October
instrument correctly.
colonies on solid microbiological (ii) A detailed explanation of the 16, 2017. The classification was
culture medium, and to interpret their interpretation of results and limitations applicable on November 20, 2015.
number, and phenotypic and regarding the need for review of culture FOR FURTHER INFORMATION CONTACT:
morphologic characteristics through plates by a qualified microbiologist, as Joshua Silverstein, Center for Devices
analysis of two dimensional digital appropriate. and Radiological Health, Food and Drug
images as an aid in diagnosis of (iii) A summary of performance data Administration, 10903 New Hampshire
infectious disease. obtained from the analytical studies Ave., Bldg. 66, Rm. 1615, Silver Spring,
(b) Classification. Class II (special used to support device performance, as MD, 20993–0002, 301–796–5155,
controls). The special controls for this appropriate. joshua.silverstein@fda.hhs.gov.
device are: (iv) A summary of performance data SUPPLEMENTARY INFORMATION:
jstallworth on DSKBBY8HB2PROD with RULES
(1) Premarket notification obtained from clinical studies
submissions must include a detailed performed on a population that is I. Background
description of the device, including the consistent with the intended use Upon request, FDA has classified the
technology employed, components and population, as appropriate. enzyme packed cartridge as class II
software modules, as well as a detailed (7) Under 21 CFR 820.30 compliant (special controls), which we have
explanation of the result algorithms and design control, device manufacturers determined will provide a reasonable
any expert rules that are used to assess must, as appropriate: assurance of safety and effectiveness. In
VerDate Sep<11>2014 14:58 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\16OCR1.SGM 16OCR1](https://thefederalregister.org/doc/82_FR_48165/page/3.svg)
Document Created: 2017-10-14 01:42:52
Document Modified: 2017-10-14 01:42:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective October 16, 2017. The classification was applicable on October 6, 2016. | |
| 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 [email protected] | |
| FR Citation | 82 FR 47967 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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