(50 days)
USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue.
USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are . composed of biosafe materials.
This document is a 510(k) Premarket Notification for a surgical suture (USSC POLYSORB CSL Suture). It is not a study describing the acceptance criteria and performance of an AI/ML-based medical device.
Therefore, I cannot provide the requested information, such as tables of acceptance criteria, device performance, sample sizes, expert qualifications, or details about AI/ML studies (MRMC, standalone).
The document's purpose is to demonstrate substantial equivalence to an already marketed device (USSC POLYSORB suture) based on:
- Biosafe materials
- Indications for use
- Manufacturing processes and controls
- Packaging processes and controls
- Sterilization processes and controls
It focuses on showing that the new suture is essentially the same as an existing one, not on providing performance metrics against specific acceptance criteria in the way an AI/ML device submission would.
§ 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.