(117 days)
The IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.
The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.
The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.
The provided text is a 510(k) Summary for a medical device (IVS Tunneller™ Device / Obturator IVS Tunneller™ Device). It outlines the device's description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a specific study proving the device meets those criteria.
The phrases "PERFORMANCE DATA: The performance of the subject IVS Tunneller™ device is substantially equivalent to the currently marketed predicate IVS Tunneller™ device." and "PERFORMANCE DATA: The performance of the subject Obturator IVS Tunneller™ device is substantially equivalent to the currently marketed predicate IVS Tunneller™ device." indicate that the device's performance was likely evaluated by comparing it to an existing device, but no details of such a study (acceptance criteria, sample size, ground truth, etc.) are included in the provided text.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the given information. The document focuses on demonstrating substantial equivalence rather than detailing performance study outcomes against specific acceptance criteria.
§ 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.