(90 days)
Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.
Deknatel® Deklene® Maxx™ Polypropylene Suture is a nonabsorbable, sterile surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is available dyed (blue) or undyed (colorless).
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) except for suture sizes 7-0 and 8-0 which differ from USP in diameter only.
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is available in USP sizes 8-0 through 0. The suture is provided in a variety of lengths, with and without 300 or 400 series stainless steel needles, with and without PTFE felt pledgets, and may be supplied in a variety of cut lengths. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
The provided text is a 510(k) summary for a medical device (surgical suture) and does not contain information about the acceptance criteria or a study proving that an AI device meets acceptance criteria. The document explicitly states: "No clinical trials were conducted."
Therefore, I cannot extract the requested information regarding AI device performance.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.