(80 days)
Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.
Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling and Surgical Mesh
This document is a 510(k) clearance letter from the FDA to ProSurg, Inc. for their Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling and Surgical Mesh. This type of document is a regulatory approval, not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and study details for a device's performance.
To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically includes such details. This 510(k) simply states that the device is substantially equivalent to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics as a device already approved by the FDA, and thus does not require extensive new clinical studies to demonstrate safety and effectiveness for market entry.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.