Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47967 

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: 

§ 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. 

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 

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 


jstallworth on DSKBBY8HB2PROD with RULES
47968 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 

False positive results (i.e., incorrect designation of plates for ‘‘Review’’ or as 

‘‘Positive’’).

General controls and special controls: (1), (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 incorrect designation of 

plates as ‘‘Negative’’).

General controls and special controls: (1), (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 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 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 

■ 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: 

§ 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 

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. 

SUMMARY: 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: 

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 


jstallworth on DSKBBY8HB2PROD with RULES