(26 days)
The GYNECARE TVT Obturator device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT Obturator device is a sterile, single patient use device, consisting of one piece of undyed or blue (Phtalocyanine blue, Color index Number 74160) PROLENE* polypropylene mesh (tape) covered by a plastic sheath overlapping in the middle. Medical grade plastic tube receptacles are attached at each end of the mesh to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT Obturator device and are used to deliver of the mesh implant via the trans-obturator “inside-out” approach. The “inside-out” approach delivers the mesh trans-vaginally, along the posterior ischiopubic ramus and through the obturator membrane.
The provided text describes a 510(k) summary for a medical device (GYNECARE TVT Obturator device) and its substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria with performance metrics.
Therefore, an analysis based on your request for acceptance criteria and study details cannot be fully generated from this document because it does not contain the requested information about a study proving the device meets acceptance criteria.
The 510(k) summary states:
- "Performance Data: Results of verification testing indicates that the product meets the established performance requirements."
However, it does not provide any specific acceptance criteria, reported device performance (metrics, thresholds), details about the study design, sample sizes, ground truth establishment, or expert involvement.
This document is primarily focused on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, form, fit, function, and method of operation. It doesn't present a detailed performance study with quantifiable 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.