ALYTE Y-MESH GRAFT

K101722 · C.R. Bard, Inc. · OTO · Apr 1, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K101722
• Device Name: ALYTE Y-MESH GRAFT
• Applicant: C.R. Bard, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Apr 1, 2011
• 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 use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapsed is warranted.

Device Story

ALYTE Y-Mesh Graft is a surgical implant for sacrocolpopexy; used to treat vaginal vault prolapse. Device consists of lightweight, non-absorbable, monofilament polypropylene mesh in a Y-configuration. Design features two anterior/posterior flaps for vaginal attachment and one sacral flap for attachment to the anterior longitudinal ligament. Includes blue polypropylene fiber indicator stripes for placement guidance. Surgeon trims graft to fit patient anatomy without unraveling. Implanted by surgeons during laparotomy or laparoscopic procedures. Provides structural support to correct pelvic organ prolapse.

Clinical Evidence

Clinical evidence included a 2010 retrospective survey of 69 sacrocolpopexy procedures in women with POP-Q stage ≥2. Median follow-up was 6 months; median POP-Q stage was 0-1. Mesh erosion rate was 2.9% (2/69). Supporting evidence included a literature review of six studies comparing synthetic mesh materials for sacrocolpopexy, confirming effectiveness in correcting pelvic organ prolapse with vaginal erosion rates within clinically acceptable ranges.

Technological Characteristics

Non-absorbable, monofilament, polypropylene mesh. Y-configuration design with blue polypropylene fiber indicator stripes. Lightweight/ultralight material. Mechanical performance characterized per FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

Indications for Use

Indicated for women requiring surgical treatment for vaginal vault prolapse via sacrocolposuspension or sacrocolpopexy (laparotomy or laparoscopic).

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

• ALYTE™ Y-Mesh Graft (BARD Graft) (K090739)
• Caldera Mesh (K060004)
• AMS Sacral Colpopexy Sling (K010931)

Submission Summary (Full Text)

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APR - 1 2011

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

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

- Scott R. Robirds Contact: Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014 Ph: 770-784-6722 Fax: [phone] E-mail: [e-mail]
Date of Submission: March 31, 2011

ALYTE™ Y-Mesh Graft Proprietary Name:

Common Name: Surgical Mesh

21 CFR 878.3300 Requiation:

Regulatory Class: =

OTO - Mesh, Surgical, Gynocological, For Apical Vaginal Prolapse, Product Codes: Transabdominally Placed

Predicate Device(s): ALYTE™ Y-Mesh Graft (BARD Graft), CR BARD, K090739 Caldera Mesh, Caldera Medical, K060004 AMS Sacral Colpopexy Sling, American Medical Systems, K010931

Device Description: The ALYTE™ Y-Mesh Graft is composed of lightweight/ultralight, non-absorbable, monofilament, polypropylene mesh. The Y configuration of the design provides two wide layers of mesh (A/P flaps) for anterior and posterior vaginal attachment that combine seamlessly into one double layer mesh (Sacral flap) for attachment to the anterior longitudinal ligament. The ALYTE™ Y-Mesh Graft contains a center line indicator created by knitting a blue polypropylene fiber in the mesh. The anterior and posterior flaps (A/P flaps) contain additional lateral indicator stripes also made from the same blue polypropylene fiber to provide guidance for placement. The graft is designed such that the surgeon will be able to alter/trim the graft to lefferent sizes and lengths as required to fit each patient's anatomical requirements without unraveling.

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K101722

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Indications for Use: The ALYTE Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapsed is warranted.

Technological Characteristics Summary: The ALYTE™ Y-Mesh Graft is composed of a non-absorbable, polymeric mesh material which is the same technology used in each of the selected predicates. The design of the subject device is a Y configuration, which is identical to the predicate Alyte Y-Mesh (K090739) and similar to the AMS Sacral Colpopexy Sling (K010931).

Non Clinical Testing: Non-clinical performance of the subject device was characterized in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999) to demonstrate substantial equivalence to the predicate device for the intended use of sacrocolposuspension. The components of the subject device have been subjected to mechanical testing and are identical to the predicate Alyte Y-Mesh (K090739) and substantially equivalent to the Caldera Mesh device (K060004). The subject device is unchanged from the device cleared in K090739; therefore stability and biocompatibility testing was not repeated.

Clinical Testing: Data were provided from a 2010 European retrospective survey of 17 surgeons who reported outcomes following 69 sacrocolpopexy procedures (approximately 2/3 laparoscopic, 1/3 laparotomy) in women with POP -Q stage >/= Stage 2 using the Alyte Y -mesh graft. Median POP-Q stage at median follow-up of approximately 6 months was Stage 0-1. Rate of erosion of mesh in this survey was 2/69 (2.9%). The 510(k) was also supported by a review of clinical studies described in the peer-review medical literature comparing different graft materials used in the pelvic floor space. Six of the studies evaluated synthetic mesh for sacrocolpopexy. Although different graft materials were compared, all studies showed effectiveness of synthetic mesh in sacrocolpopexy to correct pelvic organ prolapse. Vaginal erosion was within a clinically acceptable range.

Conclusions: The data provided in this submission demonstrate that the Alyte Y-Mesh Graft is substantially equivalent to the predicate devices for the proposed indications for use, i.e for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

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APR

1 2011

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

Mr. Scott Robirds Vice President, Regulatory and Clinical Affairs Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014

K101722 Trade/Device Name: Alyte™ Y-Mesh Graft Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated: January 26, 2011 Received: January 27, 2011

Dear Mr. Robirds:

Re:

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 of medical device-related

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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/CDRHQffices/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/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stuker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) 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): K101722 ·

Device Name: ALYTE™ Y-Mesh Graft

### Indications for Use:

The ALYTE™ Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

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

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)

Norm M Whay

of Reproductive. Gastro-Renal, and 510/k) Numbe

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