AMS LARGE PORE POLYPROPHLENE MESH

K121805 · American Medical Systems · OTO · Oct 16, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121805
• Device Name: AMS LARGE PORE POLYPROPHLENE MESH
• Applicant: American Medical Systems
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Oct 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

Device Story

IntePro® Y-Mesh is a sterile, single-use surgical mesh designed for sacrocolpopexy procedures to repair vaginal prolapse. Constructed from knitted polypropylene suture fibers, the device features a pre-formed Y-shape, bi-directional elasticity, and resistance to unraveling. It is intended for use by surgeons in clinical settings during open, laparoscopic, or robotically assisted abdominal surgeries. The mesh provides structural support to the pelvic floor, aiding in the correction of prolapse and potentially improving patient outcomes by restoring anatomical support.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and design to the predicate device.

Technological Characteristics

Constructed of knitted polypropylene suture fibers. Features bi-directional elasticity and resistance to unraveling. Provided in a pre-formed Y-shape. Sterile, single-use device.

Indications for Use

Indicated for patients requiring vaginal prolapse repair via abdominal sacrocolpopexy, including open, laparoscopic, or robotically assisted surgical approaches.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• IntePro® AMS Large Pore Polypropylene Mesh (K040521)

Submission Summary (Full Text)

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## 510(k) Summary As required by 21CFR 807.92

| 510(k) Number: | K121805 | OCT 16 2012 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date Prepared: | August 29, 2012 | |
| Submitter's Name/<br>Address: | American Medical Systems<br>10700 Bren Road W.<br>Minnetonka, MN 55343 | |
| Contact Person: | Laura Moen-Ftacek<br>Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Alternate Contact: | Melanie Hess<br>Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Device Information: | | |
| Trade Name:<br>Common Name:<br>Classification Name: | IntePro® Y-Mesh<br>Surgical Mesh<br>Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed | |

#### Predicate Device:

IntePro® AMS Large Pore Polypropylene Mesh (K040521)

Product Code:

#### Device Description:

The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.

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#### Indications for Use:

The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

#### Summary of the Technical Characteristics to the Predicate Device(s):

All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

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

OCT 16 2012

Ms. Renee Mellum Senior Regulatory Affairs Associate American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

## Re: K121805

Trade/Device Name: IntePro® Y-Mesh Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 1, 2012 Received: October 3, 2012

## Dear Ms. Mellum:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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,

Benjamin K. Firkle

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): K121805

Device Name: IntePro® Y-Mesh

Indications for Use: The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

X 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)

Jopph K. Khaz

(Division Sign-Off) ( vision of Reproductive, Gastro-Renal, an Urological Devices 510(k) Number =

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