(86 days)
The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
The SRM-Stitch™ 8F version is hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.
This document is a 510(k) premarket notification for a medical device and does not contain the specific information requested about acceptance criteria or a study that proves the device meets those criteria.
The 510(k) summary (Sections {0} and {1}) states that the SRM-Stitch™ 8F is substantially equivalent to a predicate device (SuperStitch® Vascular Suturing Device) because it has the same intended use, indications for use, principles of operation, and fundamental technological characteristics. The document mentions "minor modifications" to the suture sleeve and guidewire port but asserts these "do not raise any new questions of safety or effectiveness."
The FDA letter (Sections {2} and {3}) confirms the substantial equivalence determination for the device based on the information provided in the 510(k) submission.
Therefore, I cannot provide the requested information, which typically would be found in a detailed study report or clinical trial summary. This 510(k) entry is a regulatory filing focused on demonstrating equivalence to an already approved device rather than presenting new performance study data 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.