(34 days)
The Arthrex Fiberwire™USP size 5 suture is intended for use in soft tissue approximation and or ligation.
Arthrex, Inc. Fiberwire™ suture is 38 " in length and has a diameter of 0.700 to 0.799 mm. It is made of long chain polyesters which are braided and sterilized and for surqical use. It is available in dyed and non-dyed varieties, with or without needles.
The provided document is a 510(k) summary for a surgical suture (Arthrex Fiberwire™ USP size 5 suture). It does NOT contain information about acceptance criteria, device performance studies, or AI/software validation.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to predicate devices based on basic features and intended use, rather than detailed performance studies with acceptance criteria commonly found for AI/imaging devices.
§ 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.