(315 days)
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) consists of a stainless steel needle and poly(ethylene terephthalate) suture, for use in short term tissue approximation, including use in ophthalmic surgery.
The provided text is a 510(k) summary for the MANI Needle and Suture Pack. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided document.
§ 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.