22 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

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. 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 

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 

the guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in part 21 CFR 807, subpart 

E, regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; 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 864 

Blood, Medical devices, Packaging 

and containers. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 864 is 

amended as follows: 

PART 864—HEMATOLOGY AND 

PATHOLOGY DEVICES 

■ 1. The authority citation for part 864 

is revised to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 864.3700 to subpart D to read 

as follows: 

§ 864.3700 Whole slide imaging system. 

(a) Identification. The whole slide 

imaging system is an automated digital 

slide creation, viewing, and 

management system intended as an aid 

to the pathologist to review and 

interpret digital images of surgical 

pathology slides. The system generates 

digital images that would otherwise be 

appropriate for manual visualization by 

conventional light microscopy. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include the following 

information: 

(i) The indications for use must 

specify the tissue specimen that is 

intended to be used with the whole 

slide imaging system and the 

components of the system. 

(ii) A detailed description of the 

device and bench testing results at the 

component level, including for the 

following, as appropriate: 

(A) Slide feeder; 

(B) Light source; 

(C) Imaging optics; 

(D) Mechanical scanner movement; 

(E) Digital imaging sensor; 

(F) Image processing software; 

(G) Image composition techniques; 

(H) Image file formats; 

(I) Image review manipulation 

software; 

(J) Computer environment; and 

(K) Display system. 

(iii) Detailed bench testing and results 

at the system level, including for the 

following, as appropriate: 

(A) Color reproducibility; 

(B) Spatial resolution; 

(C) Focusing test; 

(D) Whole slide tissue coverage; 

(E) Stitching error; and 

(F) Turnaround time. 

(iv) Detailed information 

demonstrating the performance 

characteristics of the device, including, 

as appropriate: 

(A) Precision to evaluate intra-system 

and inter-system precision using a 

comprehensive set of clinical specimens 

with defined, clinically relevant 

histologic features from various organ 

systems and diseases. Multiple whole 

slide imaging systems, multiple sites, 

and multiple readers must be included. 

(B) Reproducibility data to evaluate 

inter-site variability using a 

comprehensive set of clinical specimens 

with defined, clinically relevant 

histologic features from various organ 

systems and diseases. Multiple whole 

slide imaging systems, multiple sites, 

and multiple readers must be included. 

(C) Data from a clinical study to 

demonstrate that viewing, reviewing, 

and diagnosing digital images of 

surgical pathology slides prepared from 

tissue slides using the whole slide 

imaging system is non-inferior to using 

an optical microscope. The study 

should evaluate the difference in major 

discordance rates between manual 

digital (MD) and manual optical (MO) 

modalities when compared to the 

reference (e.g., main sign-out diagnosis). 

(D) A detailed human factor 

engineering process must be used to 

evaluate the whole slide imaging system 

user interface(s). 

(2) Labeling compliant with 21 CFR 

809.10(b) must include the following: 

(i) The intended use statement must 

include the information described in 

paragraph (b)(1)(i) of this section, as 

applicable, and a statement that reads, 

‘‘It is the responsibility of a qualified 

pathologist to employ appropriate 

procedures and safeguards to assure the 

validity of the interpretation of images 

obtained using this device.’’ 

(ii) A description of the technical 

studies and the summary of results, 

including those that relate to paragraphs 

(b)(1)(ii) and (iii) of this section, as 

appropriate. 

(iii) A description of the performance 

studies and the summary of results, 

including those that relate to paragraph 

(b)(1)(iv) of this section, as appropriate. 

(iv) A limiting statement that specifies 

that pathologists should exercise 

professional judgment in each clinical 

situation and examine the glass slides 

by conventional microscopy if there is 

doubt about the ability to accurately 

render an interpretation using this 

device alone. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28262 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2017–N–6596] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Irrigating Wound Retractor Device 

AGENCY: Food and Drug Administration, 

HHS. 


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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 23 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the irrigating wound 

retractor device 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 irrigating 

wound retractor device’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 January 2, 

2018. The classification was applicable 

on December 16, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Terrell Cunningham, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2502, Silver Spring, 

MD 20993–0002, 301–796–6299, 

terrell.cunningham@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

irrigating wound retractor device 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 

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 (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 (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

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 August 13, 2015, Prescient 

Surgical submitted a request for De 

Novo classification of the CleanCisionTM

Wound Retraction and Protection 

System. 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 the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on December 16, 2016, 

FDA issued an order to the requester 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 878.4371. We 

have named the generic type of device 

irrigating wound retractor device, and it 

is identified as a prescription device 

intended to be used by a surgeon to 

retract the surgical incision, to provide 

access to the surgical wound, to protect 

and irrigate the surgical wound, and to 

serve as a conduit for removal of fluid 

from the surgical wound. 

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—IRRIGATING WOUND RETRACTOR DEVICE RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Adverse tissue reaction ............................................................................ Biocompatibility evaluation.

Tissue or wound damage ......................................................................... Non-clinical performance testing, Shelf life testing, and Labeling. 


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24 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

TABLE 1—IRRIGATING WOUND RETRACTOR DEVICE RISKS AND MITIGATION MEASURES—Continued 

Identified risks Mitigation measures 

Infection .................................................................................................... Sterilization validation, Non-clinical performance testing, Shelf life testing, and Labeling. 

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. 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. 

At the time of classification, irrigating 

wound retractor devices are for 

prescription use only. Prescription 

devices are exempt from the 

requirement for adequate directions for 

use for the layperson under section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) and 21 CFR 801.5, as long as 

the conditions of 21 CFR 801.109 are 

met (referring to 21 U.S.C. 352(f)(1)). 

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 

the guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120, and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 878 

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 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for part 878 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 878.4371 to subpart E to read 

as follows: 

§ 878.4371 Irrigating wound retractor 

device. 

(a) Identification. An irrigating wound 

retractor device is a prescription device 

intended to be used by a surgeon to 

retract the surgical incision, to provide 

access to the surgical wound, to protect 

and irrigate the surgical wound, and to 

serve as a conduit for removal of fluid 

from the surgical wound. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible and 

evaluated for particulate matter. 

(2) Performance data must 

demonstrate the sterility and 

pyrogenicity of the patient-contacting 

components of the device. 

(3) Performance data must support 

shelf life by demonstrating continued 

functionality and sterility of the device 

over the identified shelf life. 

(4) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. Performance testing 

must: 

(i) Characterize the tear resistance, 

tensile strength, and elongation 

properties of the barrier material; 

(ii) Demonstrate that the liquid barrier 

material is resistant to penetration by 

blood, and is non-flammable; 

(iii) Characterize the forces required 

to deploy the device; 

(iv) Characterize the device’s ranges of 

operation, including flow rates and 

maximum suction pressures; 

(v) Demonstrate the ability of the 

device irrigation apparatus to maintain 

a user defined or preset flow rate to the 

surgical wound; and 

(vi) Demonstrate the ability of the 

device to maintain user defined or 

preset removal rates of fluid from the 

surgical wound. 

(5) The labeling must include or state 

the following information: 

(i) Device size or incision length 

range; 

(ii) Method of sterilization; 

(iii) Flammability classification; 

(iv) Non-pyrogenic; 

(v) Shelf life; and 

(vi) Maximum flow rate and suction 

pressure. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28255 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[TD 9829] 

RIN 1545–BN77 

Election Out of the Centralized 

Partnership Audit Regime 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulation. 

SUMMARY: This document contains final 

regulations regarding the 

implementation of certain portions of 

section 1101 of the Bipartisan Budget 

Act of 2015 (BBA), which was enacted 

into law on November 2, 2015. Section 

1101 of the BBA repeals the current 

rules governing partnership audits and 

replaces them with a new centralized 

partnership audit regime that, in 

general, assesses and collects tax at the 

partnership level. This document 

provides final regulations for electing 

out of the centralized partnership audit 

regime. The final regulations affect 

partnerships for taxable years beginning 

after December 31, 2017. 


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