AMS PERIGEE SYSTEM

K040623 · American Medical Systems, Inc. · OTP · May 17, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040623
• Device Name: AMS PERIGEE SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

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 Story

The AMS Perigee™ System is a surgical instrument kit designed for the treatment of anterior vaginal wall prolapse. The system comprises specialized needles and connectors used to facilitate the placement of a polypropylene mesh graft into the anterior vaginal wall via the obturator foramen. The device is intended for use by surgeons in a clinical or operating room setting. The mesh provides structural support to the anterior vaginal wall to correct prolapse. The system relies on the mechanical properties of the polypropylene mesh and the surgical technique for placement to achieve clinical benefit.

Clinical Evidence

Bench testing only. The mesh and system components were tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, demonstrating mechanical performance and biocompatibility equivalent to predicate devices.

Technological Characteristics

System consists of needles, connectors, and polypropylene mesh. Materials are biocompatible. Mechanical performance evaluated per FDA guidance for surgical mesh. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring surgical treatment of anterior vaginal wall prolapse via placement of graft material in the anterior vaginal wall through the obturator foramen.

Regulatory Classification

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).

Predicate Devices

• AMS Sparc Sling System (K011251)
• AMS Monarc Sling System (K023516)
• AMS BioArc (K030123)
• AMS Large Pore Polypropylene Mesh (K033636)
• AMS Large Pore Polypropylene Mesh (K040521)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: [phone] Fax: [phone]

# 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

{1}------------------------------------------------

addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.

.

.

KOYD623

{2}------------------------------------------------

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

{3}------------------------------------------------

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 [phone] or [phone] 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

{4}------------------------------------------------

# 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

Page 1 of _1

510(k) Number_________________________________________________________________________________________________________________________________________________________________