(134 days)
StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.
StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch.
Each StitchKit® version contains strands of existing legally-marketed Suturing Materials. The subject StitchKit® versions contain:
- StitchKit® V-Loc™90: Contains Covidien V-Loc™90 Wound Closure -Devices
- -StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices
- -StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures
The provided text is a 510(k) premarket notification for a medical device called StitchKit®. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-based product. As such, it does not contain the information requested regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or MRMC studies.
The document primarily discusses the physical characteristics and intended use of the StitchKit® (a suture delivery canister) and conducts performance testing to show it functions comparably to predicate suture materials and delivery systems.
Therefore, I cannot provide the requested information based on the provided text.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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.