(145 days)
The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of:
a .Endoscopic Marking
b. Hemostasis for:
- Mucosal/Submucosal defects
The Disposable Hemostatic Closure Clip Device is a sterile, single-use endoscopic clipping device, intended for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The device is indicated for clip placement within the GI tract for the purpose of.
a. endoscopic marking
b. hemostasis for:
- mucosal/submucosal defects
The provided text describes the acceptance criteria and the studies performed to demonstrate the substantial equivalence of the "Disposable Hemostatic Closure Clip Device" (Proposed Device) to the "OTSC™ (Over-The-Scope-Clip) System Set" (Predicate Device).
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a separate section with pass/fail results for each criterion. Instead, it states that various performance tests were conducted, and the results demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device.
The table below summarizes the technical characteristics compared, which implicitly serve as acceptance criteria for similarity to the predicate device. The "Remark" column indicates if the characteristic is "Same" or "Similar" to the predicate, implying acceptance if it falls within these categories or if differences do not affect substantial equivalence.
| ITEM | Acceptance Criteria (Implicitly based on Predicate) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| Product Code | PKL | PKL | Same |
| Regulation No. | 876.4400 Hemorrhoidal ligator | 876.4400 Hemorrhoidal ligator | Same |
| Class | II | II | Same |
| Intended use | The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects |
§ 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.