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(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.
[83 FR 27703, June 14, 2018]
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