Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26991 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for part 870 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 870.1342 to subpart B to read 

as follows: 

§ 870.1342 Reverse central venous 

recanalization system. 

(a) Identification. A reverse central 

venous recanalization system is a 

prescription device for obtaining central 

venous access to facilitate catheter 

insertion into the central venous system. 

Reverse recanalization involves the 

initiation of an access path from within 

the vein and then progressing to the 

skin for patients with upper body 

venous occlusions or other conditions 

that preclude central venous access by 

other methods. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

fulfill the following: 

(i) Demonstrate the ability to safely 

deliver, deploy, and remove the device; 

and 

(ii) Evaluate all adverse events 

including death, bleeding, damage to 

non-target tissue and organs, blood 

vessel perforation or rupture, and 

hematoma. 

(2) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Simulated-use testing in a 

clinically relevant bench anatomic 

model to assess the delivery, 

deployment, and retrieval of the system; 

(ii) Compatibility with other devices 

labeled for use with the device; 

(iii) Tensile strengths of joints and 

components; 

(iv) Kink resistance of system 

components; 

(v) Radiopacity of components used to 

monitor procedure under fluoroscopy; 

(vi) Characterization and verification 

of all dimensions; and 

(vii) Leakage of air or fluid. 

(3) All patient contacting components 

of the device must be demonstrated to 

be biocompatible. 

(4) Performance data must 

demonstrate the sterility of the device 

components intended to be provided 

sterile. 

(5) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(6) Labeling for the device must 

include: 

(i) Instructions for use, including a 

description of compatible devices; 

(ii) A detailed summary of the clinical 

testing conducted and; 

(iii) Shelf life and storage conditions. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09745 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 876 

[Docket No. FDA–2022–N–0141] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Magnetically Maneuvered Capsule 

Endoscopy System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the magnetically 

maneuvered capsule endoscopy system 

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 

magnetically maneuvered capsule 

endoscopy system’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. 

DATES: This order is effective May 6, 

2022. The classification was applicable 

on May 22, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Cole, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2536, Silver Spring, 

MD 20993–0002, 301–796–8587, 

Stephanie.Cole@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

magnetically maneuvered capsule 

endoscopy system 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 (see 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) of the FD&C Act. 

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 


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26992 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 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 August 13, 2019, FDA received 

AnX Robotica, Inc.’s request for De 

Novo classification of the NaviCam 

Capsule Endoscope System with 

NaviCam Stomach Capsule. 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 May 22, 2020, 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 876.1310.1 We have named the 

generic type of device magnetically 

maneuvered capsule endoscopy system, 

and it is identified as consisting 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. 

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—MAGNETICALLY MANEUVERED CAPSULE ENDOSCOPY SYSTEM RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Infection .................................................................................................... Reprocessing validation, Sterilization validation, and Labeling. 

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

Aspiration of capsule leading to injury ..................................................... Labeling. 

Tissue damage ......................................................................................... Clinical performance testing, and Labeling. 

Equipment malfunction leading to injury .................................................. Electrical, thermal, and mechanical safety testing; Software validation, 

verification, and hazard analysis; Human factors testing; Non-clinical 

performance testing; Shelf life testing; and Labeling. 

Interference with other devices (e.g., interference with image acquisition, patient information compromised, and ferromagnetic implants in 

users and patients).

Electromagnetic compatibility testing; Software validation, verification, 

and hazard analysis; Non-clinical performance testing; and Labeling. 

Failure to visualize areas of the stomach and duodenum leading to inadequate treatment.Clinical performance testing, Non-clinical performance testing, and Labeling. 

Failure to excrete the capsule due to an obstruction resulting in abdominal pain, nausea, and vomiting.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. 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 

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 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 


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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’ 


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