(90 days)
The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.
A surgically implantable polypropylene mesh bolster with monofilament sutures.
The provided text is a 510(k) summary for the Island Biosurgical Bladder Neck Suspension Bolster. It explicitly states:
"Performance testing: Performance testing was not included in this 510 (k)."
Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance against such criteria, or any study that proves the device meets acceptance criteria.
As a result, I cannot provide the requested information. This device received substantial equivalence without requiring performance testing to demonstrate its safety and effectiveness.
§ 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.