(315 days)
Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.
The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:
- Intended use
- Material
- Design
- Performance (Diameter, Needle attachment, and Tensile strength)
- Sterilization method
- Biocompatibility evaluation
The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.
§ 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.