(116 days)
The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
-
Endoscopic marking:
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Hemostasis for:
a.Mucosal/sub-mucosal defects
The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
This document outlines the acceptance criteria and supporting studies for the Micro-Tech (Nanjing) Co., Ltd. Disposable Dual Action Tissue Closure Device (K233772).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device as substantially equivalent to a predicate device (K212748) except for one indication and shelf-life, and therefore, directly stated acceptance criteria are not explicitly presented as separate quantitative values for each performance test. Instead, the document relies on demonstrating that the proposed device performs the same or better than the predicate device for all shared characteristics, and that the changes in indications and shelf-life are supported by additional testing or literature.
Below is a table summarizing the performance data presented, emphasizing the comparison to the predicate device.
| Test Item / Characteristic | Acceptance Criteria (Implied by Predicate Equivalence or Specific Testing) | Reported Device Performance (Proposed Device K233772) |
|---|---|---|
| Form Factor / Dimensions | Same as predicate (K212748) | Same as predicate (K212748), including: |
- Open width (15 mm)
- Working Length (1650, 1950, 2350 mm)
- Minimal working channel of endoscopy (3.2 mm) |
| Material / Configuration | Same as predicate (K212748) | Same as predicate (K212748) |
| Principles of Operation | Same as predicate (K212748) | Same as predicate (K212748) |
| Endoscopic Marking Indication | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Bleeding Ulcers | Same as predicate (K212748) | Same as predicate (K212748) |
| **Hemostasis for Polyps (
§ 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.