(119 days)
The "Fast Throw" Stainless Steel Surgical Suture is indicated for use in superficial skin closure.
The Advanced Surgical Products "Fast Throw" Stainless Steel Surgical Suture is a sterile single use knot-less suture that is primarily designed for skin wound closure The device incorporates barbs along the length of the suture and works in conjunction with a Tshaped backstop incorporated at the proximal end of the device. As the suture is passed through the wound, the wound is cinched up to the T-shaped backstop.
This is a 510(k) premarket notification for a medical device (a surgical suture), not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable in the context of AI/ML performance evaluation.
The document describes the device, its intended use, comparison to predicate devices, and pre-clinical data (needle attachment pull strength and tensile testing per USP standards, and in vivo testing). The FDA determined substantial equivalence based on this information.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.