Document ID: FDA-2021-N-0285-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Gastroenterology- Urology Devices; Classification of the Esophageal Tissue Characterization System
Posted Date: 2021-12-02T05:00Z

[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68398-68399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26200]

[[Page 68398]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0285]

Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Esophageal Tissue Characterization System

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the esophageal tissue characterization 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 esophageal tissue characterization 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 December 2, 2021. The classification was 
applicable on December 23, 2019.

FOR FURTHER INFORMATION CONTACT: Pramodh Kariyawasam, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002, 
301-348-1911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the esophageal tissue 
characterization 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, 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 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 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 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 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 December 17, 2018, Diversatek Healthcare Inc. submitted a 
request for De Novo classification of the Mucosal Integrity 
Conductivity Test 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 23, 2019, FDA issued an order to the 
requester classifying the device into class II. In this final order,\1\ 
FDA is codifying the classification of the device by adding 21 CFR 
876.1450. We have named the generic type of device esophageal tissue 
characterization system, and it is identified as a device intended for 
obtaining measurements of electrical properties within esophageal 
tissue.
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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.

[[Page 68399]]

 Table 1--Esophageal Tissue Characterization System Risks and Mitigation
                                Measures
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            Identified risks                   Mitigation measures
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Device malfunction related to:           Nonclinical performance
 Breaking                         testing; Shelf life testing;
 Fractures                        Software verification,
 Unintentional separation of      validation, and hazard
 components                               analysis; and Labeling.
 Inaccurate reading
 Failure to sense
 Endoscope incompatibility
Adverse tissue reaction................  Biocompatibility evaluation.
Electrical shock and electrical          Electrical safety testing,
 interference from other devices.         Electromagnetic compatibility
                                          (EMC) testing, and Labeling.
Procedural risks (which may include      Labeling.
 procedures of endoscopy with sedation).
Infection/cross-contamination..........  Reprocessing validation,
                                          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

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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. 3501-3521). 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 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 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.  876.1450 to subpart B to read as follows:

Sec.  876.1450  Esophageal tissue characterization system.

    (a) Identification. An esophageal tissue characterization system is 
a device intended for obtaining measurements of electrical properties 
within esophageal tissue.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the device can accurately 
measure the designated electrical characteristics.
    (3) Mechanical safety testing must demonstrate that the device will 
withstand forces encountered during use.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Electromagnetic compatibility and electrical safety, mechanical 
safety, and thermal safety of the device must be performed.
    (6) Performance data must validate the reprocessing instructions 
for any reusable components of the device.
    (7) Labeling must include:
    (i) Specific instructions regarding the proper placement and use of 
the device;
    (ii) Instructions for reprocessing of any reusable components; and
    (iii) An expiration date for single use components.

    Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26200 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P