(50 days)
Polyglytone*6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic Surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.
This document is a 510(k) summary for a synthetic absorbable suture. It outlines the device description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, or any study details that would allow a description of how the device meets acceptance criteria.
The information provided only demonstrates that the device's substantial equivalence determination was based on:
- A detailed device description.
- Performance testing (details not provided).
- Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, U.S.P. - Absorbable Surgical Sutures).
- Guidance from the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA".
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because those details are not present in the provided text.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.