ARTISYN Y-SHAPED MESH

K113205 · ETHICON, Inc. · OTO · Jun 11, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113205
• Device Name: ARTISYN Y-SHAPED MESH
• Applicant: ETHICON, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Jun 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ARTISYN™ Y-Shaped Mesh is a surgical implant used to support pelvic floor organs. It consists of a Y-shaped configuration with a vaginal section (anterior/posterior flaps) and a sacral section for attachment to the sacral promontory. The device is constructed from partially absorbable mesh (polypropylene and poliglecaprone-25 monofilament). Blue polypropylene stripes are incorporated into the mesh to assist surgeons with positioning, trimming, and suturing during the procedure. The device is used by surgeons in an operating room setting to treat vaginal vault prolapse. By providing a bridging material for sacrocolposuspension/sacrocolpopexy, the mesh helps restore pelvic organ support, potentially improving patient outcomes related to prolapse.

Clinical Evidence

Bench testing only. Mechanical performance testing was conducted in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' (March 22, 1999). Results demonstrated that the device provides performance similar to the predicate devices.

Technological Characteristics

Y-shaped surgical mesh composed of non-absorbable polypropylene and absorbable poliglecaprone-25 monofilament. Features blue polypropylene contrast striping for surgical guidance. Dimensions and shape are similar to predicate Y-mesh devices. Mechanical performance characterized per FDA surgical mesh guidance.

Indications for Use

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

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, CR BARD (K101722)
• GYNECARE GYNEMESH M® Partially Absorbable Mesh, ETHICON Inc. (K082216)
• RESTORELLE® Y, Mpathy Medical Devices, Ltd. (K092207)

Submission Summary (Full Text)

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K113205

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

:

JUN 1 2 2012

| Sponsor: | ETHICON Women's Health and Urology<br>ETHICON, Inc.<br>P.O. Box 151<br>Route 22 West<br>Somerville, New Jersey 08876 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah McManus<br>ETHICON Women's Health and Urology<br>ETHICON, Inc.<br>P.O. Box 151<br>Route 22 West<br>Somerville, New Jersey 08876<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | 13 January 2012 |
| Proprietary Name: | ARTISYN™ Y-Shaped Mesh |
| Common Name: | Surgical Mesh |
| Regulation: | 21 CFR878.3300 |
| Regulatory Class: | II |
| Product Codes: | OTO - Mesh, Surgical, Gynecologic, For Apical Vaginal Prolapse,<br>Transabdominally Placed.<br>FTL - Mesh, Surgical, Polymeric |
| Predicate Devices: | ALYTE™ Y-Mesh Graft, CR BARD, K101722<br>GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216<br>RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 |
| Device Description: | ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh<br>provided in a Y shape: a vaginal section with anterior/posterior flaps and a<br>sacral section. The anterior and posterior flaps are for anterior and posterior<br>vaginal attachment, and the sacral flap for attachment to the sacral<br>promontory. The mesh consists of non-absorbable undyed and dyed<br>polypropylene and absorbable undyed poliglecaprone-25 monofilament. The |

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vaginal and sacral sections are sewn together using polypropylene monofilament. Blue polypropylene monofilaments have been incorporated in the mesh material to produce contrast striping. The vertical stripes on the sacral flap and the horizontal stripes on the anterior and posterior vaginal flaps help aid in positioning, trimming and suturing the mesh.

ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for Indications for Use sacrocolposuspension/sacrocolpopexy (laparatomy or laparascopic approach) where surgical treatment for vaginal vault prolapse is warranted.

ARTISYN™ Y-Shaped Mesh is composed of the same partially absorbable mesh Technological material used in the predicate device, GYNECARE GYNEMESH M® Partially Characteristics Absorbable Mesh. The design of the ARTISYN™ Y-Shaped Mesh is a Y Summary configuration with a similar shape and similar dimensions as the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.

Non-clinical performance of the ARTISYN™ Y-Shaped Mesh was characterized Performance Data 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 devices. The mesh material used in the ARTISYN™ Y-Shaped Mesh device has been subjected to mechanical testing and is identical to the predicate, GYNECARE GYNEMESH M® Partially Absorbable Mesh, and substantially equivalent to the predicate, BARD ALYTE™ Y-Mesh Graft. The finished ARTISYN™ Y-Shaped Mesh device was subjected to mechanical testing and is substantially equivalent to the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.

Conclusions

The data provided in this premarket notification demonstrate that the ARTISYN™ Y-Shaped Mesh is substantially equivalent to the predicate devices. All four devices have the same intended use, fundamental technology and principle of operation.

ARTISYN™ Y-Shaped Mesh and the three predicate devices, BARD ALYTE® Y-Mesh Graft, GYNECARE GYNEMESH M® Partially Absorbable Mesh and Mpathy MEDICAL RESTORELLE® Y are surgical mesh intended to support organs in the pelvic floor to address pelvic organ prolapse. ARTISYN™ Y-Shaped Mesh, BARD ALYTE® Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y are the same shape and same approximate dimensions. ARTISYN™ Y-Shaped Mesh and GYNECARE GYNEMESH M® Partially Absorbable Mesh are made of the same mesh material.

Bench testing was performed in accordance with the FDA guidance document Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999. Results show that all four devices provide similar performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 1 1 2012

Ms. Sarah McManus Manager, Regulatory Affairs ETHICON Women's Health and Urology ETHICON, Inc. P.O. Box 151. Route 22 West SOMERVILLE NJ 08876

K113205 Re:

. •

Trade/Device Name: ARTISYN™ Y-Shaped Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: May 18, 2012 Received: May 21, 2012

Dear Ms. McManus:

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 (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" (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,

Sincerely yours,

Benjamin K. Kirk

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):

Device Name: ARTISYN™Y-Shaped Mesh

Indications for Use:

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

Prescription Use_ V 21 CFR Part 801 Subpart D

and/or

Over-the-Counter Use 21 CFR Part 801 Subpart C

(Please DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

6/11/2012

Division of Reproductive, Gastro-Renal, and
Urological Devices K1/3205
510(k) Number.