(78 days)
Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.
PROMEDON's Sling, SAFYRE, is manufactured with biocompatible silicone elastomers and polypropylene. It is a permanent implant and is offered as a single use sterile product. Safyre consists of a pierced polypropylene mesh between two silicone columns that are made of multiple cone-shaped soft tissue anchors. The e units are the basis of the self anchoring system. The polypropylene shilles on the mid-urethra and the interconnective tissue grows among me the perforations between the vaginal flap and the urethra, which leads to internation of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia. This self anchoring is enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.
The provided text is a 510(k) Summary for the SAFYRE Sling, which is a premarket notification for a medical device. This document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- "Bench testing and biocompatibility testing was performed on the SAFYRE Sling." (Page 2, Section 7. Performance Testing). However, no details about the results, acceptance criteria, or specific study designs for these tests are provided.
- The FDA letter (Pages 3-4) confirms that the device was found "substantially equivalent" to predicate devices, which is a regulatory determination based on comparison to existing legally marketed devices, not typically on a new performance study proving acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on establishing substantial equivalence to predicate devices, not on presenting detailed performance study results 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.