(90 days)
The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
A single-use, surgical instrument for placing stainless steel sutures.
The provided text is related to a 510(k) submission for the Manual Touché Suturing System. However, it does not contain information about acceptance criteria, device performance testing, or study details (like sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The document primarily focuses on:
- Identifying the device (Manual Touché Suturing System).
- Claiming substantial equivalence to predicate devices (Powered Touché Suturing System and Salute Fixation System).
- Describing the subject device and comparing its technical aspects to predicate devices.
- Stating its intended use and indications.
- Providing the FDA's clearance letter for the device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information on the study design elements you asked for. The document does not describe the specific testing or studies conducted to prove the device meets performance criteria.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.