(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."
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MAY 1 7 2004
510(k) Summary AMS Perigee™ System
page lot 2
510(k) Number_K 040623
Date of Summary Preparation: March 8, 2004
Submitter/Contact Person:
Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6000 Fax: (952) 930-6496
Device Name and Classification:
Trade Name: AMS Perigee™ System Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP, PAI Classification: Class II
Manufacturing Location:
American Medical Systems. Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
AMS Sparc Sling System - K011251 AMS Monarc Sling System - K023516 AMS BioArc - K030123 AMS Large Pore Polypropylene Mesh - K033636, K040521
Indications for 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 Perigee™ System consists of needles and connectors used to pass a polypropylene mesh for support of the anterior vaginal wall.
Summary of Testing
The mesh used in the Perigee™ System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In
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addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.
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KOYD623
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
Re: K040623 Trade/Device Name: AMS Perigee™ System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP. PAI Dated: March 8, 2004 Received: March 9, 2004
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of May 17, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K040623
Device Name: AMS Perigee™ System
Indications for 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.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.