AMS LARGE PORE POLYPROPYLENE MESH

K033636 · American Medical Systems, Inc. · OTP · Dec 31, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K033636
• Device Name: AMS LARGE PORE POLYPROPYLENE MESH
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Dec 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The AMS Large Pore Polypropylene Mesh is 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.

Device Story

AMS Large Pore Polypropylene Mesh is a knitted polypropylene fiber mesh; designed for surgical implantation to reinforce and stabilize pelvic floor fascial structures in cases of vaginal wall prolapse. Device acts as mechanical support or bridging material for fascial defects. Mesh is cut to desired shape/size by surgeon during procedure; resists unraveling. Used in clinical/surgical settings by physicians. Provides structural reinforcement to pelvic floor tissues; intended to benefit patients by stabilizing fascial structures.

Clinical Evidence

Bench testing only. Biocompatibility of polypropylene material demonstrated. Mechanical characterization performed in accordance with FDA guidance for surgical mesh.

Technological Characteristics

Knitted polypropylene fiber mesh; biocompatible material; cut-to-size form factor; resists unraveling. No electronic components or software.

Indications for Use

Indicated for patients requiring tissue reinforcement and stabilization of pelvic floor fascial structures for vaginal wall prolapse, serving as mechanical support or bridging material for fascial defects.

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

• Gynemesh Prolene Soft Mesh (K013718)
• Ethicon Prolene Soft Mesh (K001122)
• AMS Sacral Colpopexy Sling (K010931)

Submission Summary (Full Text)

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K033636 P/2

DEC 3 1 2003

# 510(k) Summary AMS Large Pore Polypropylene Mesh

510(k) Number _

### Date of Summary Preparation: November 17, 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 Large Pore Polypropylene Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP, OTO Classification: Class II

# Manufacturing Location:

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

#### Predicate Devices:

Gynemesh Prolene Soft Mesh - K013718 Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling - K010931

## Indications for Use:

The AMS Large Pore Polypropylene Mesh is 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.

### Device Description:

The AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.

## Summary of Testing

The material used in the AMS Large Pore Polypropylene Mesh has been demonstrated to be biocompatible.

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K033636
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In addition, the AMS Large Pore Polypropylene Mesh has been tested for a in addition, the AMG Largo Ford : crypt a coordance with FDA's Guidance for the vanety of mechaniour characteristication for a Surgical Mesh and has r repuration of a vemaintent to the listed predicate devices.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a bird, or possibly a bird in flight. The symbol is rendered in solid black, creating a strong contrast against the white background.

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: K033636 Trade/Device Name: AMS Large Pore Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 17, 2003 Received: November 19, 2003

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of December 31, 2003.

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,

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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K033636

# INDICATIONS FOR USE ENCLOSURE

510(k) Number:

AMS Large Pore Polypropylene Mesh Device Name:

Indications for Use: The AMS Large Pore Polypropylene Mesh is indicated for midications for Ose. The Ame Eargo volte , byt it is cial structures of the pelvic tissue relimordement and long thems withing surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Prescription Use مكو (Part 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)

Miriam C. Provost

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

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510(k) Number K633636