(24 days)
The Modified Auto Suture* VCS** Anastomotic** clip cartridge is intended for use in the anastomosis of vascular structures and in the attachment of synthetic vascular prosthesis.
The Modified Auto Suture* VCS** Anastomotic** clip cartridge uses titanium implantable clips to hold everted tissue edges together for the creation of vascular anastomosis.
The provided text does not contain information about acceptance criteria, device performance, or studies in the context of a medical device's analytical or clinical validation, especially not in a way that aligns with the requested format (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details). Instead, the document describes a 510(k) submission for a Modified Auto Suture* VCS** Anastomotic** Clip Cartridge, focusing on its regulatory approval process, intended use, and substantial equivalence to predicate devices.
Therefore, I cannot fulfill your request for an acceptance criteria table and study details based on the provided text. The information required for such a response (like performance metrics, study designs, and data characteristics) is simply not present in the given document.
§ 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.