(239 days)
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects
ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is pre-loaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.
ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.
Here's an analysis of the acceptance criteria and the study information for the ClearEndoclip device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or a pass/fail percentage for a diagnostic or AI-driven device.
Instead, the performance data section focuses on demonstrating conformance to established standards and comparing the device's characteristics to a predicate device. The general acceptance criterion seems to be "demonstrates equivalent safety and performance profile as the predicate device" and "conformance to the appropriate recognized standards of FDA, ISO 10993-1 (2009)."
Here's a summary of the performance claims:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Favorable biocompatibility test results drawn in 2018 testing, ensuring FDA's latest consensus standards (ISO 10993-1: 2009) are met. Classified as "Implant Device - Tissue/bone/dentin (Prolonged contact duration)" for the clip and "Externally Communicating Devices ( |
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.