Rule2022-09735
Medical Devices; Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System
Primary source
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Published
May 6, 2022
Effective
May 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 88 (Friday, May 6, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#e9ba9d8c99818887808cc7aa86858ca98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="d487a0b1a4bcb5babdb1fa97bbb8b194b2b0b5fabcbca7fab3bba2">[email protected]</span></a>.
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.
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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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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
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