RESTORELLE Y CONTOUR

K123914 · Coloplast A/S · OTO · Mar 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123914
• Device Name: RESTORELLE Y CONTOUR
• Applicant: Coloplast A/S
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Mar 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Story

Restorelle Y Contour is a sterile, Y-shaped surgical mesh used as a bridging material for sacrocolposuspension or sacrocolpopexy. It is implanted by surgeons (gynecologists/urologists) during laparotomy, laparoscopic, or robotic procedures to treat vaginal vault prolapse. The device acts as a structural support to reinforce pelvic floor tissues. It is constructed from non-absorbable, monofilament polypropylene. The device is provided sterile and is intended for single-use during surgical intervention.

Clinical Evidence

No clinical data. Bench testing, biocompatibility, shelf life, and sterilization validations were not required as the device is identical in materials and design to the predicate Restorelle Y.

Technological Characteristics

Non-absorbable, monofilament polypropylene mesh; Y-shape; pore size 1.80 x 1.83 mm; dimensions 24 x 3 cm; sterilization via Ethylene Oxide.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal vault prolapse; used as a bridging material for sacrocolposuspension or sacrocolpopexy via laparotomy, laparoscopic, or robotic 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

• Restorelle® Y (K112322)

Submission Summary (Full Text)

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K123914
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#### 510(k) Summary

ﺎ ﺳﺮ

# MAR 0 5 2013

| Submitter: | Coloplast A/S<br>Holtedam 1<br>Humlebaek Denmark |
|--------------------|-------------------------------------------------------------------------------------------------------------|
| Company Contact: | Tim Crabtree<br>Regulatory Affairs Manager<br>Phone: [phone] Fax: [phone]<br>[e-mail] |
| Date Prepared: | December 14, 2012 |
| Device Name: | Restorelle® Y Contour |
| Common Name: | Surgical Mesh |
| Regulation: | 21 CFR §878.3300 |
| Regulatory Class: | Class II |
| Product Code: | OTO-Mesh, Surgical, Gynecological, For Apical Vaginal<br>Prolapse, Transabdominally Placed. |
| Predicate Devices: | Restorelle® Y (K112322) |

Description of Device: Restorelle L Contour is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a Y shaped mesh that is designed for the treatment of apical vaginal prolapse.

Indication for Use: Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Technological Characteristics Summary: The Coloplast Restorelle Y Contour shares the same materials, features, intended use, and technological characteristics as Restorelle Y. Restorelle Y Contour differs in the sacral flap dimension which is 3 cm wide versus the 4 cm wide of the original Restorelle Y. All other properties, materials, packaging, shelf life and sterilization remain unchanged.

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K123914
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| Property | Subject Device<br>Restorelle Y Contour | Predicate Device<br>Restorelle Y |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Restorelle L Polypropylene<br>Mesh is indicated for use as a<br>bridging material for<br>sacrocolposuspension /<br>sacrocolpopexy (laparotomy<br>laparoscopic or robotic<br>approach) where surgical | Restorelle Y Polypropylene<br>Mesh is indicated for use as a<br>bridging material for<br>sacrocolposuspension /<br>sacrocolpopexy (laparotomy<br>laparoscopic or robotic<br>approach) where surgical |
| | treatment for vaginal vault<br>prolapse is warranted. | treatment for vaginal vault<br>prolapse is warranted. |
| Material | Non-absorbable, monofilament<br>polypropylene mesh | Non-absorbable, monofilament<br>polypropylene mesh |
| Dimensions | 24x 3cm | 24 x 4cm & 27 x 4cm |
| Shape | Y | Y |
| Pore Size<br>(mm) | 1.80 x 1.83 | 1.80 x 1.83 |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide |
| Product<br>Code | OTO | OTO |

The only difference in properties between the subject and predicate devices is size. Since the subject device falls in the range between the predicated devices, no new issues, regarding safety and efficacy, have been identified. Therefore the subject device is substantially equivalent to the cited predicate devices for indications, materials and technological features.

Performance Summary: Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle Y Contour since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle Contour device.

Conclusions: The performance and non-clinical cited supporting this submission demonstrates that the Restorelle Y Contour is substantially equivalent to Restorelle Y mesh.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

#### Public Health Service

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

March 5, 2013

Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corporation 1601 West River Road North MINNEAPOLIS MN 55411

Re: K123914

Trade/Device Name: Restorelle® Y Contour Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: February 4, 2013 Received: February 7, 2013

Dear Mr. Crabtree:

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.

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Page 2 – Mr. Tim Crabtree

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 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,

Image /page/3/Picture/9 description: The image shows the name "Benjamin R Fisher-S" in a stylized font. The words are written in black ink on a white background. The letters "R" and "F" are stylized with a geometric pattern.

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): K123914

Device Name: Restorelle® Y Contour

Indications for Use: Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

# Benjamin Bestisky
2013.03.05 05 03.03 05 0

uctive, Gastro-Renal, and k) Number

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