(90 days)
MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair.
The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, stainless steel needle and a plastic handle.
The provided text is a 510(k) summary for the MR-III Suture Retention Device. It does not contain information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria. The document primarily focuses on the administrative aspects of a 510(k) submission, including company contact, device description, predicate devices, and intended use as well as the FDA's decision letter. Studies proving performance are not part of the 510(k) Summary. Therefore, I cannot generate the requested table and study details from the provided input.
§ 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.