AMS APOGEE VAULT SUSPENSION SYSTEM

K040537 · American Medical Systems, Inc. · OTP · Apr 22, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040537
• Device Name: AMS APOGEE VAULT SUSPENSION SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Device Story

Apogee™ Vault Suspension System is a surgical kit for pelvic organ prolapse repair. It consists of needles and connectors used to implant a polypropylene mesh to support the vaginal vault. The device is used by surgeons in a clinical or operating room setting. The mesh provides structural support to the vaginal vault, intended to correct prolapse and improve patient outcomes. The system is designed for manual operation by the physician during the surgical procedure.

Clinical Evidence

Bench testing only. The mesh and system components were tested for mechanical performance and biocompatibility in accordance with FDA guidance for surgical mesh, demonstrating equivalence to predicate devices.

Technological Characteristics

Polypropylene mesh, needles, and connectors. The device is a manual surgical instrument system. No electronic components, software, or energy sources are utilized. Sterilization is performed per standard medical device manufacturing practices.

Indications for Use

Indicated for patients requiring vaginal vault suspension to treat pelvic organ prolapse.

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, K013355, K020663)
• AMS Monarc Sling System (K023516)
• AMS BioArc (K030123)
• AMS Large Pore Polypropylene Mesh (K033636)
• IVS Tunneller (K010035)

Submission Summary (Full Text)

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APR 2 2 2004

page 4/2

# 510(k) Summary AMS Apogee™ Vault Suspension System KO4053

## 510(k) Number

## Date of Summary Preparation: March 1, 2003

### 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 Apogee™ Vault Suspension System Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP Classification: Class II

## Manufacturing Location:

American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343

## Predicate Devices:

AMS Sparc Sling System - K011251, K013355, K020663 AMS Monarc Sling System - K023516 AMS BioArc - K030123 AMS Large Pore Polypropylene Mesh - K033636 IVS Tunneller - K010035

#### Indications for Use:

The Apoqee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

#### Device Description:

The Apogee™ Vault Suspension System consists of needles and connectors used to pass a polypropylene mesh for support of the vaginal vault.

#### Summary of Testing

The mesh used in the Apogee™ Vault Suspension System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated

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K040537 page 2/2

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substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is simple and recognizable, and it is often used on official documents and websites.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K040537 Trade/Device Name: Apogee™ Vault Suspension System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 1, 2004 Received: March 2, 2004

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of April 22, 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 your 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Fuchs

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

510(k) Number (if known): K040537

Device Name: Apogee™ Vault Suspension System

Indications For Use: The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Prescription Use______________________________________________________________________________________________________________________________________________________________ × (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)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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