Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26993 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; 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 876 

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 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 876.1310 to subpart B to read 

as follows: 

§ 876.1310 Magnetically maneuvered 

capsule endoscopy system. 

(a) Identification. A magnetically 

maneuvered capsule endoscopy system 

consists of an ingestible capsule and 

magnetic controller and is used for 

visualization of the stomach and 

duodenum. The ingestible capsule 

contains a camera that wirelessly 

captures images of the mucosa. The 

magnetic controller is used outside of 

the patient and is magnetically coupled 

with the capsule to control its location 

and viewing direction. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing with 

the device under anticipated conditions 

of use must evaluate visualization of the 

intended region and document the 

adverse event profile. 

(2) Non-clinical testing data must 

demonstrate the optical, mechanical, 

and functional integrity of the device 

under physically stressed conditions. 

The following performance 

characteristics must be tested, and 

detailed protocols must be provided for 

each test: 

(i) A bite test must be performed to 

ensure that the capsule can withstand 

extreme cases of biting; 

(ii) A pH resistance test must be 

performed to evaluate integrity of the 

capsule when exposed to a 

physiological relevant range of pH 

values; 

(iii) A battery life test must be 

performed to demonstrate that the 

capsule’s operating time is not 

constrained by the battery capacity; 

(iv) A shelf life test must be 

performed to demonstrate that the 

device performs as intended at the 

proposed shelf life date; 

(v) Optical testing must be performed 

to evaluate fundamental image quality 

characteristics such as resolution, field 

of view, depth of field, geometric 

distortion, signal to noise ratio, dynamic 

range, and image intensity uniformity; 

(vi) A color performance test must be 

performed to compare the color 

differences between the input scene and 

output image; 

(vii) A photobiological safety analysis 

must be performed based on maximum 

(worst-case) light exposure to internal 

gastrointestinal mucosa, and covering 

ultraviolet, visible, and near-infrared 

ranges, as appropriate. A mitigation 

analysis must be provided; 

(viii) Performance testing must 

demonstrate that the viewing software 

clearly presents the current frame rate, 

which is either adjustable manually by 

the user or automatically by the device. 

Testing must demonstrate that the 

viewing software alerts the user when 

the video quality is reduced from 

nominal due to imaging data 

communication or computation 

problems; 

(ix) A data transmission test must be 

performed to verify the robustness of the 

data transmission between the capsule 

and the receiver. This test must include 

controlled signal attenuation for 

simulating a non-ideal environment; 

and 

(x) Magnetic field strength testing 

characterization must be performed to 

identify the distances from the magnet 

that are safe for patients and users with 

ferromagnetic implants, devices, or 

objects. 

(3) Software validation, verification, 

and hazard analysis must be provided. 

(4) Electrical safety, thermal safety, 

mechanical safety, and electromagnetic 

compatibility testing must be 

performed. 

(5) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(6) Performance data must validate 

the reprocessing instructions for the 

reusable components of the device. 

(7) Performance data must 

demonstrate the sterility of any device 

components labeled sterile. 

(8) Human factors testing must 

demonstrate that the intended users can 

safely and correctly use the device, 

based solely on reading the instructions 

for use. 

(9) Clinician labeling must include: 

(i) Specific instructions and the 

clinical and technical expertise needed 

for the safe use of the device; 

(ii) A detailed summary of the clinical 

testing pertinent to use of the device, 

including information on effectiveness 

and device- and procedure-related 

complications; 

(iii) The patient preparation 

procedure; 

(iv) A detailed summary of the device 

technical parameters; 

(v) Magnetic field safe zones; 

(vi) A screening checklist to ensure 

that all patients and operating staff are 

screened from bringing ferromagnetic 

implants, devices, or objects near the 

external magnet; 

(vii) Reprocessing instructions for 

reusable components; 

(viii) Shelf life for single use 

components; and 

(ix) Use life for reusable components. 

(10) Patient labeling must include: 

(i) An explanation of the device and 

the mechanism of operation; 

(ii) The patient preparation 

procedure; 

(iii) A brief summary of the clinical 

study; and 

(iv) A summary of the device- and 

procedure-related complications 

pertinent to use of the device. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09735 Filed 5–5–22; 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–2022–N–0175] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Mountable Electromechanical Surgical 

System for Transluminal Approaches 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the mountable 

electromechanical surgical system for 

transluminal approaches 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 

mountable electromechanical surgical 

system for transluminal approaches’ 


JSPEARS on DSK121TN23PROD with RULES1
26994 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

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. 

DATES: This order is effective May 6, 

2022. The classification was applicable 

on February 26, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Virag Patel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4609, Silver Spring, 

MD 20993–0002, 301–796–0452, 

Virag.Patel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

mountable electromechanical surgical 

system for transluminal approaches 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 

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 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

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 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

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 is required to 

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. 

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 section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On April 17, 2019, FDA received 

Memic Innovative Surgery Ltd.’s request 

for De Novo classification of the 

Hominis Surgical 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 February 26, 2021, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 878.4961.1 We have named the 

generic type of device mountable 

electromechanical surgical system for 

transluminal approaches, and it is 

identified as a software-controlled, 

patient bed- and/or operating tablemounted electromechanical surgical 

system with human/device interfaces 

that allows a qualified user to perform 

transluminal endoscopic or 

laparoscopic surgical procedures using 

surgical instruments attached to an 

electromechanical arm. 

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. 


JSPEARS on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26995 

TABLE 1—MOUNTABLE ELECTROMECHANICAL SURGICAL SYSTEM FOR TRANSLUMINAL APPROACHES RISKS AND

MITIGATION MEASURES

Identified risks Mitigation measures 

Thermal, electrical, or mechanical fault, or system malfunction resulting 

in tissue perforation or injury to patient or user.

Non-clinical performance testing; Electrical safety testing; Electromagnetic compatibility (EMC) testing; Software verification, validation, and hazard analysis; Human factors assessment; Clinical performance testing; Annual reporting; and Labeling. 

Use error resulting in patient injury: .........................................................

• Dehiscence or delayed healing at the device access site. 

• Hemorrhage. 

• Thromboembolism. 

• Transluminal risks. 

Non-clinical performance testing; Human factors assessment; Training; 

Clinical performance testing; Post-market surveillance; Annual reporting; Control on distribution; and Labeling. 

Adverse tissue reaction ............................................................................ Biocompatibility evaluation, and Pyrogenicity testing. 

Infection .................................................................................................... Biocompatibility evaluation; Pyrogenicity testing; Sterilization validation; 

Reprocessing validation; Shelf-life testing; Clinical performance 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. 

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 

While this final order contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this final order. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 822, 

regarding postmarket surveillance of 

medical devices, have been approved 

under OMB control number 0910–0449; 

the collections of information in 21 CFR 

part 860, subpart D, regarding De Novo 

classification 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 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, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; 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 § 878.4961 to subpart E to read 

as follows: 

§ 878.4961 Mountable electromechanical 

surgical system for transluminal 

approaches. 

(a) Identification. A mountable 

electromechanical surgical system for 

transluminal approaches is a softwarecontrolled, patient bed- and/or 

operating table-mounted 

electromechanical surgical system with 

human/device interfaces that allows a 

qualified user to perform transluminal 

endoscopic or laparoscopic surgical 

procedures using surgical instruments 

attached to an electromechanical arm. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device manufacturer must 

develop, and update as necessary, a 

device-specific use training program 

that ensures proper device setup/use/ 

shutdown, accurate control of 

instruments to perform the intended 

surgical procedures, troubleshooting 

and handling during unexpected events 

or emergencies, and safe practices to 

mitigate use error. 

(2) The device manufacturer may only 

distribute the device to facilities that 

implement and maintain the devicespecific use training program and 

ensure that users of the device have 

completed the device-specific use 

training program. 

(3) The device manufacturer must 

conduct and complete post-market 

surveillance, including an impact of the 

training program on user learning, 

behavior, and performance, in 

accordance with an FDA-agreed-upon 

protocol. The device manufacturer must 

submit post-market surveillance reports 

that contain current data and findings in 

accordance with the FDA-agreed-upon 

protocol. 

(4) The device manufacturer must 

submit a report to FDA annually on the 

anniversary of initial marketing 

authorization for the device, until such 

time as FDA may terminate such 

reporting, which comprises the 

following information: 

(i) Cumulative summary, by year, of 

complaints and adverse events since 

date of initial marketing authorization; 

and 

(ii) Identification and rationale for 

changes made to the device, labeling or 

device-specific use training program, 

which did not require submission of a 

premarket notification during the 

reporting period. 

(5) Labeling must include: 

(i) A detailed summary of clinical 

performance testing conducted with the 

device, including study population, 

results, adverse events, and 

comparisons to any comparator groups 

identified; 


JSPEARS on DSK121TN23PROD with RULES1
26996 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 

(ii) A statement in the labeling that 

the safety and effectiveness of the 

device has not been evaluated for 

outcomes related to the treatment or 

prevention of cancer, including but not 

limited to risk reduction, overall 

survival, disease-free survival and local 

recurrence, unless FDA determines that 

it can be removed or modified based on 

clinical performance data submitted to 

FDA; 

(iii) Identification of compatible 

devices; 

(iv) The list of surgical procedures for 

which the device has been determined 

to be safe with clinical justification; 

(v) Reprocessing instructions for 

reusable components; 

(vi) A shelf life for any sterile 

components; 

(vii) A description of the devicespecific use training program; 

(viii) A statement that the device is 

only for distribution to facilities that 

implement and maintain the devicespecific use training program and 

ensure that users of the device have 

completed the device-specific use 

training program; and 

(ix) A detailed summary of the postmarket surveillance data collected 

under paragraph (b)(3) of this section 

and any necessary modifications to the 

labeling to accurately reflect outcomes 

based upon the post-market surveillance 

data collected under paragraph (b)(3) of 

this section. 

(6) Clinical performance testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use. 

(7) Human factors validation testing 

must be performed and must 

demonstrate that the user interfaces of 

the system support safe use in an 

operating room environment. 

(8) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use and must include: 

(i) Device motion accuracy and 

precision; 

(ii) System testing; 

(iii) Instrument reliability; 

(iv) Thermal effects on tissue; 

(v) Human-device interface; 

(vi) Mounting hardware testing; 

(vii) Workspace access testing; and 

(viii) Performance testing with 

compatible devices. 

(9) Software verification, validation, 

and hazard analysis must be performed. 

Software documentation must include 

an assessment of the impact of threats 

and vulnerabilities on device 

functionality and end users/patients as 

part of cybersecurity review. 

(10) Electromagnetic compatibility 

and electrical, thermal, and mechanical 

safety testing must be performed. 

(11) Performance data must 

demonstrate the sterility of all patientcontacting device components. 

(12) Performance data must support 

the shelf life of the device components 

provided sterile by demonstrating 

continued sterility and package integrity 

over the labeled shelf life. 

(13) Performance data must validate 

the reprocessing instructions for the 

reusable components of the device. 

(14) Performance data must 

demonstrate that all patient-contacting 

components of the device are 

biocompatible. 

(15) Performance data must 

demonstrate that all patient-contacting 

components of the device are nonpyrogenic. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09749 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2022–0227] 

Special Local Regulation; Crystal Pier 

Outrigger Race, San Diego, CA 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the Crystal Pier Outrigger Race special 

local regulations on the waters of 

Mission Bay, California, on May 7, 2022. 

These special local regulations are 

necessary to provide for the safety of the 

participants, crew, spectators, sponsor 

vessels, and general users of the 

waterway. During the enforcement 

period, persons and vessels are 

prohibited from anchoring, blocking, 

loitering, or impeding within this 

regulated area unless authorized by the 

Captain of the Port, or his designated 

representative. 

DATES: The regulations in 33 CFR 

100.1101 will be enforced from 7 a.m. 

through 5 p.m. on May 7, 2022, for the 

locations described in Item No. 14 in 

Table 1 to § 100.1101. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Commander John 

Santorum, Waterways Management, 

U.S. Coast Guard Sector San Diego, CA; 

telephone 619–278–7656, email 

MarineEventsSD@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulations in 33 CFR 100.1101 for the 

Crystal Pier Outrigger Race in Mission 

Bay, CA in 33 CFR 100.1101, for the 

locations described in Item No. 14 in 

Table 1 to that section from 7 a.m. until 

5 p.m. on May 7, 2022. This 

enforcement action is being taken to 

provide for the safety of life on 

navigable waterways during the event. 

The Coast Guard’s regulation for 

recurring marine events in the San 

Diego Captain of the Port Zone 

identifies the regulated entities and area 

for this event. Under the provisions of 

33 CFR 100.1101, persons and vessels 

are prohibited from anchoring, blocking, 

loitering, or impeding within this 

regulated area, unless authorized by the 

Captain of the Port, or his designated 

representative. The Coast Guard may be 

assisted by other Federal, State, or local 

law enforcement agencies in enforcing 

this regulation. 

In addition to this document in the 

Federal Register, the Coast Guard will 

provide the maritime community with 

advance notification of this enforcement 

period via the Local Notice to Mariners, 

marine information broadcasts, and 

local advertising by the event sponsor. 

If the Captain of the Port Sector San 

Diego or his designated representative 

determines that the regulated area need 

not be enforced for the full duration 

stated on this document, he or she may 

use a Broadcast Notice to Mariners or 

other communications coordinated with 

the event sponsor to grant general 

permission to enter the regulated area. 

Dated: May 2, 2022. 

T.J. Barelli, 

Captain, U.S. Coast Guard, Captain of the 

Port San Diego. 

[FR Doc. 2022–09722 Filed 5–5–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0190] 

RIN 1625–AA00 

Safety Zone; Sabine River, Orange, TX 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

certain navigable waters of the Sabine 


JSPEARS on DSK121TN23PROD with RULES1