(99 days)
UniPro is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable ploypropylene surgical suture
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "UniPro", which is a nonabsorbable polypropylene surgical suture.
This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It does not contain information about:
- Specific acceptance criteria for device performance.
- The details of any studies (clinical or benchtop) conducted to demonstrate performance.
- Sample sizes for test or training sets.
- Ground truth establishment or expert qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
The document states the "Indications for Use" but does not delve into the technical performance metrics or the studies supporting them. These details would typically be found in the 510(k) submission itself, which is not provided here.
§ 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.