Document ID: FDA-2018-N-1862-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the
Endoscopic Electrosurgical Clip Cutting System
Posted Date: 2018-06-14T04:00Z

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27702-27704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12794]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2018-N-1862]

Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Endoscopic Electrosurgical Clip Cutting System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the endoscopic electrosurgical clip cutting 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 endoscopic electrosurgical clip cutting 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, in part by reducing regulatory burdens.

DATES: This order is effective June 14, 2018. The classification was 
applicable on December 22, 2017.

FOR FURTHER INFORMATION CONTACT: Purva Pandya, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G223, Silver Spring, MD 20993-0002, 240-402-9979, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the endoscopic electrosurgical 
clip cutting 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 reducing 
regulatory burdens 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate 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), respectively).
    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 shall 
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 within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. 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. As a result, other device sponsors do 
not have to submit a De Novo request or PMA in order 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 April 11, 2016, Ovesco Endoscopy AG submitted a request for De 
Novo classification of the remOVE 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.

[[Page 27703]]

    Therefore, on December 22, 2017, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.4310. We have named 
the generic type of device endoscopic electrosurgical clip cutting 
system, and it is identified as a prescription device that applies 
electrical energy to fragment metallic clips, which are devices placed 
in the digestive tract to close gastrointestinal perforations, 
hemorrhages, or perform resection. The system includes instruments that 
are then used to remove the fragmented clips from the digestive tract.
    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--Endoscopic Electrosurgical Clip Cutting System Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Unintended tissue damage (burns,         Animal performance testing, Non-
 perforations, bleeding).                 clinical performance testing,
                                          Electrical and thermal safety
                                          testing, Usability testing,
                                          and Labeling.
Electromagnetic interference/Electrical  Electromagnetic compatibility
 shock.                                   testing, Electrical safety
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life 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. We encourage sponsors to consult 
with us if they wish to use a non-animal testing method they believe is 
suitable, adequate, validated, and feasible. We will consider if such 
an alternative method could be assessed for equivalency to an animal 
test method. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, endoscopic electrosurgical clip 
cutting systems are for prescription use only. Prescription devices are 
exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as 
long as the conditions of 21 CFR 801.109 are met (referring to 21 
U.S.C. 352(f)(1)).

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. 3501-3520). 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; 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.  876.4310 to subpart E to read as follows:

Sec.  876.4310  Endoscopic electrosurgical clip cutting system.

    (a) Identification. An endoscopic electrosurgical clip cutting 
system is a prescription device that applies electrical energy to 
fragment metallic clips, which are devices placed in the digestive 
tract to close gastrointestinal perforations, hemorrhages, or perform 
resection. The system includes instruments that are then used to remove 
the fragmented clips from the digestive tract.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) 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) Performance bench testing to evaluate the functionality 
(including stress, compatibility, usability, and reliability) of the 
device during use;
    (ii) Electrical and thermal safety testing; and
    (iii) Electromagnetic compatibility testing.
    (2) Animal testing must evaluate tissue damage, including thermal 
effects, during the clip removal procedure. This testing must also 
evaluate usability and effectiveness of the device.
    (3) The 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 shelf life by demonstrating 
continued sterility of the device (or the sterile components), package 
integrity, and device functionality over the labeled shelf life.
    (6) Labeling of the device must include:
    (i) Instructions for use, and
    (ii) A shelf life for single use components.

[[Page 27704]]

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12794 Filed 6-13-18; 8:45 am]
 BILLING CODE 4164-01-P