(10 days)
Novafil** and Vascufil** Sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.
Novafil** non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol.
Vascufil** coated non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol. The suture is coated with POLYTRIBOLATE**, an absorbable polymer of e-caprolactone / glycolide / poloxamer 188.
This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The provided text is a 510(k) summary for a medical suture (Novafil and Vascufil) to establish substantial equivalence to a predicate device. It discusses the device description, intended use, and regulatory classification, but it does not detail performance metrics, test methodologies, or clinical studies that would be relevant to an AI/ML system's evaluation.
Therefore, I cannot provide the requested information.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.