(93 days)
The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Cytoplast PTFE Suture." It confirms that the device has been found substantially equivalent to a predicate device.
This document DOES NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document primarily focuses on regulatory clearance, device classification, and indications for use. It does not include performance data, clinical study details, or analytical validation results.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.