(69 days)
The Perigee™ System is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior vaginal wall prolapse.
The Perigee™ System consists of needles and connectors used to pass a polypropylene mesh for support of the anterior vaginal wall.
This document describes a 510(k) premarket notification for the AMS Perigee™ System, a surgical mesh device. The review of the provided text reveals that it does not contain the information requested in the prompt regarding acceptance criteria and a study to prove device performance.
The document primarily focuses on:
- Administrative details: Submitter contact, device name and classification, manufacturing location, summary preparation date, and 510(k) number.
- Predicate devices: A list of previously cleared AMS sling and mesh systems.
- Intended Use: "The Perigee™ System is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior vaginal wall prolapse."
- Device Description: The system consists of needles and connectors for passing a polypropylene mesh.
- Summary of Testing (limited): It states the mesh was tested according to FDA guidance and shown to be equivalent to predicate devices, and other components demonstrated substantial equivalence in mechanical performance and biocompatibility.
- FDA Communication: A letter from the FDA confirming substantial equivalence and outlining regulatory responsibilities.
- Indications for Use Statement: A form reiterating the intended use.
Therefore, I cannot provide the requested information as it is not present in the provided text.
To answer your prompt, specific study reports, performance data, and detailed acceptance criteria for the AMS Perigee™ System would be necessary. This type of detailed performance data is typically found in the full 510(k) submission, particularly in sections like "Performance Data" or "Non-Clinical Studies."
§ 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.