(29 days)
SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
The SuperStitch® Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch® applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots, Optional accessories for use with the SuperStitch® include the KnotPusher™ for advancing the knot to the wound site and the Kwiknot™ knot tying device.
The principal differences between the modified SuperStitch® and the cleared SuperStitch® are: (1) changes made within the operating mechanism to improve manufacturability; (2) the addition of longer lengths to accommodate longer (i.e., 25cm) sheaths; (3) change in package to a single sterile barrier; (4) the inclusion of a modified KnotPusher™ accessory that is packaged with the SuperStitch® (5) a change in one of the cannula materials; and (6) the addition of a smaller (6 French) size for compatibility with 6 French procedural sheaths.
The Sutura SuperStitch® is a prescription device, restricted to use by or on the order of physicians.
The Sutura SuperStitch® is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.
The provided text does not contain detailed information about acceptance criteria, specific studies with device performance metrics, sample sizes, expert qualifications, or ground truth methodologies. The document is a 510(k) summary for a medical device (SuperStitch® Vascular Suture Delivery Device) seeking substantial equivalence to a predicate device.
Instead, the summary focuses on establishing substantial equivalence based on comparisons of design, indications, materials, and principle of operation with a previously cleared device. It states that "The differences in the technological characteristics and size of the modified SuperStitch® have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use."
However, it does not provide specific details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies or their effect sizes.
- Standalone algorithm performance studies.
- The type of ground truth used.
- Sample sizes for training sets or how their ground truth was established.
Therefore, I cannot provide the requested table and information based directly on the provided text. The document serves as regulatory submission highlighting equivalence rather than a detailed study report with specific performance metrics against defined acceptance criteria.
§ 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.