[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Rules and Regulations]
[Pages 26991-26993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2022-N-0141]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Magnetically Maneuvered Capsule Endoscopy System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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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, 
[email protected].

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

[[Page 26992]]

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.
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    \1\ FDA 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.
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    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
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            Identified risks                   Mitigation measures
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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.,   Electromagnetic compatibility
 interference with image acquisition,     testing; Software validation,
 patient information compromised, and     verification, and hazard
 ferromagnetic implants in users and      analysis; Non-clinical
 patients).                               performance testing; and
                                          Labeling.
Failure to visualize areas of the        Clinical performance testing,
 stomach and duodenum leading to          Non-clinical performance
 inadequate treatment.                    testing, and Labeling.
Failure to excrete the capsule due to    Clinical performance testing,
 an obstruction resulting in abdominal    and Labeling.
 pain, nausea, and vomiting.
------------------------------------------------------------------------

    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

[[Page 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--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  876.1310 to subpart B to read as follows:


Sec.  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