BARD SACROCOLPOPEXY GRAFT

K090739 · C.R. Bard, Inc. · OTO · Nov 10, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090739
• Device Name: BARD SACROCOLPOPEXY GRAFT
• Applicant: C.R. Bard, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Nov 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alyte™ Y-Mesh Graft 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

Alyte™ Y-Mesh Graft is a surgical implant for vaginal wall prolapse repair. Device consists of lightweight/ultra-lightweight, nonabsorbable monofilament polypropylene mesh. Y-shape design allows surgeon to trim graft to fit patient-specific anatomical requirements without unraveling. Used by surgeons in clinical settings to provide mechanical support or bridge fascial defects. Device provides long-lasting stabilization of pelvic floor structures, potentially improving patient outcomes in prolapse repair surgeries.

Clinical Evidence

Bench testing only. Testing conducted in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

Technological Characteristics

Nonabsorbable monofilament polypropylene mesh; lightweight/ultra-lightweight construction; Y-shape form factor; trimmable design; non-unraveling material properties.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal wall prolapse; used for tissue reinforcement and stabilization of pelvic floor fascial structures as mechanical support or bridging material.

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

• Minimesh® Polypropylene Mesh (K053361)
• American Medical Systems Y-Mesh Graft (K033636)
• American Medical Systems Y-Mesh Graft (K040521)

Submission Summary (Full Text)

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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

く

NOV 1 0 2009

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

### A. SUBMITTER INFORMATION:

Submitter's Name:

Address:

Contact Person: Contact Person's Telephone Number: Contact Person's Fax:

Ms. Julie Bassett 770-784-6375 770-385-4706

Covington, GA 30014

C. R. Bard, Inc. Bard Medical Division 8195 Industrial Blvd.

#### B. Device Name:

| Trade Name(s): | Alyte ^TM Y-Mesh Graft |
|-----------------------|----------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Names: | OTQ - Mesh, Surgical, Polymeric |
| CFR Reference: | 21 CFR 878.3300 |
| Classification Panel: | General and Plastic Surgery |

#### C. Predicate Device Name:

Moathy Medical Devices Ltd. Minimesh® Polypropylene Trade Names: Mesh - K053361 and American Medical Systems Y-Mesh Graft - K033636, K040521

#### D. DEVICE DESCRIPTION:

The Alyte™ Y-Mesh Graft is a surgical implant used in the repair of vaginal wall prolapse. The graft is comprised of a lightweight/ultra-lightweight, nonabsorbable monofilament polypropylene mesh. The graft is designed such that the surgeon will be able to alter/trim the graft to different sizes as required to fit each patient's anatomical requirements without unraveling. The graft is available in a Y shape as a convenience to the physician.

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#### E. INDICATIONS FOR USE:

The Alyte™ Y-Mesh Graft 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.

- F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject Alyte™ Y-Mesh Graft has the same intended use and technological characteristics as the predicate devices.

#### ઉં. Performance Data Summary:

The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

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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 stylized eagle or bird symbol inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

C.R. Bard, Inc. % Ms. Julie Bassett Regulatory Affairs Specialist II 8195 Industrial Boulevard COVINGTON GA 30014

SEP 2 8 2012

Re: K090739 Trade/Device Name: Alyte™ Y-Mesh Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: September 18, 2009 Received: September 23, 2009

Dear Ms. Bassett:

This letter corrects our substantially equivalent letter of November 10, 2009.

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/ReportalProblem/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 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

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# Ko90 739

1.1 Indications for Use Statement

K090739 510(k) Number (if known): __

Alyte™ Y-Mesh Graft Device Name:

Indications for Use:

The Alyte™ Y-Mesh Graft 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

× Prescription Use (Pari 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Daniel Klans for MXY.

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090739

(Recommended Format 11/13/2003)