(85 days)
For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.
This document is a 510(k) Premarket Notification for a Suture/Mesh Fixation System (K021384/K021834). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process for this type of device (Class II surgical suture) typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the same way a novel high-risk device or an AI/ML powered device might.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory classification, intended use, and the claim of substantial equivalence.
§ 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.