(164 days)
The Coloplast Exair Anterior and Posterior prolapse repair systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.
The provided text is for a 510(k) summary for a medical device called Exair Anterior and Posterior Prolapse Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The summary states that "Substantial equivalence is supported by bench testing comparing Exair to the predicate devices and biocompatibility testing performed on the Exair device and instrumentation." This indicates non-clinical testing was performed, but no details about specific performance metrics or acceptance criteria for that testing are provided in this document.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.