(17 days)
The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve . and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.
This 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document describes a medical device called the "VIRTUE Ventral Urethral Elevation Sling System" and its substantial equivalence to a previously cleared device. It details the device's components (polypropylene mesh with four arms, sleeves, sutures, and an introducer), its intended use for male stress urinary incontinence (SUI), and the regulatory classification.
The document is a regulatory communication from the FDA to Coloplast Corporation, confirming the substantial equivalence of the modified VIRTUE device. It does not include performance data, clinical study results, or specific acceptance criteria.
Therefore, I cannot provide the requested information from this text.
§ 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.