MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH

K040521 · American Medical Systems, Inc. · OTP · Mar 24, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040521
• Device Name: MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Special
• 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 provide mechanical support or bridging for fascial defects in pelvic floor reconstruction. Device is cut to size by surgeon during procedure; resists unraveling. Provides long-lasting stabilization of fascial structures in vaginal wall prolapse cases. Used in clinical/surgical settings by physicians. Benefits include structural reinforcement of weakened pelvic floor tissues.

Clinical Evidence

Bench testing only; performed in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'.

Technological Characteristics

Knitted polypropylene fiber mesh; resists unraveling; cut-to-size form factor. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for patients requiring tissue reinforcement and stabilization of pelvic floor fascial structures for vaginal wall prolapse. Used 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

• AMS Large Pore Polypropylene Mesh (K033636)

Submission Summary (Full Text)

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K040521 Page '1/

MAR 2 4 2004

# 510(k) SUMMARY

| Submitter's Name: | American Medical Systems, Inc. |
|------------------------------|--------------------------------------------------------------------------------------------------|
| Address: | 10700 Bren Road West<br>Minnetonka, MN 55343 |
| Tel: | 952-930-6000 |
| Fax: | 952-930-6157 |
| Contact Person: | Elsa A. Linke |
| Date of Summary Preparation: | February 27, 2004 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | AMS Large Pore Polypropylene Mesh |
| Device Classification Name: | Surgical Mesh, polymeric (21 CFR 878.3300)<br>Classification: Class II<br>Product Code: OTP, OTO |
| Predicate Device: | AMS Large Pore Polypropylene Mesh<br>K033636 |

### 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.

#### Indications for Use

The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and longlasting 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.

#### Comparison to Predicate Device

The fundamental scientific technology of this device and the predicate device does not differ. The base material and mesh design remain the same.

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K040521 page 2/2

[510(k) Summary continued]

#### Summary of Testing

The new device 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 device.

#### Conclusion

The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

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: K040521 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: February 27, 2004 Received: March 1, 2004

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of March 24, 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. Weeks

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): | K040521 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AMS Large Pore Polypropylene Mesh |
| Indications For Use: | The AMS Large Pore Polypropylene Mesh is<br>indicated for tissue reinforcement and long-lasting<br>stabilization of fascial structures of the pelvic floor in<br>vaginal wall prolapse where surgical treatment is<br>intended, either as mechanical support or bridging<br>material for the fascial defect. |

Prescription Use_ × (Per 21 CFR 801 Subpan 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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