RESTORELLE L

K122440 · Coloplast Corp. · OTO · Nov 19, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122440
• Device Name: RESTORELLE L
• Applicant: Coloplast Corp.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Nov 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restorelle L 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 L is a sterile, flat, non-absorbable monofilament polypropylene surgical mesh (24cm x 8cm). It is used by surgeons during sacrocolposuspension or sacrocolpopexy procedures (laparotomy, laparoscopic, or robotic) to treat vaginal vault prolapse. The mesh acts as a bridging material to provide structural support to the vaginal vault. It is a passive implantable device; no electronic or algorithmic components are involved. The device is substantially equivalent to existing polypropylene meshes, differing only in physical dimensions.

Clinical Evidence

No clinical data. Bench testing and biocompatibility data from the predicate Restorelle Y were leveraged as the subject device is identical in materials and design.

Technological Characteristics

Non-absorbable, monofilament polypropylene mesh; flat form factor; 24cm x 8cm dimensions; 1.80mm x 1.83mm pore size; Ethylene Oxide sterilization.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal vault prolapse; used as a bridging material for sacrocolposuspension/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)
• Vertessa™ Polypropylene Mesh (K120327)

Submission Summary (Full Text)

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Page 1 of 2

## 510(k) Summary

# K122440

| Submitter: | Coloplast A/S<br>Holtedam 1<br>Humlebaek Denmark | | NOV 1 9 2012 |
|--------------------|-------------------------------------------------------------------------------------------------------------|--|--------------|
| Company Contact: | Tim Crabtree<br>Regulatory Affairs Manager<br>Phone: [phone] Fax: [phone]<br>[e-mail] | | |
| Date Prepared: | November 6, 2012 | | |
| Device Name: | Restorelle® L | | |
| 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), Vertessa™ Polypropylene Mesh<br>(K120327) | | |

Description of Device: Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

Indication for Use: Restorelle L Polypropylene Mesh 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 L shares the same materials, features, intended use, and technological characteristics as Restorelle Y. Restorelle L also shares the same materials, intended use and shape of the Vertessa Polypropylene Mesh. The follow table lists the properties associated with the subject and predicate devices.

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K122440
Page 2 of 2

| Property | Subject Device<br>Restorelle L | Predicate Device<br>Restorelle Y | Predicate Device<br>Vertessa<br>Polypropylene Mesh |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Restorelle L<br>Polypropylene Mesh is<br>indicated for use as a<br>bridging material for<br>sacrocolposuspension /<br>sacrocolpopexy<br>(laparotomy laparoscopic<br>or robotic approach) where<br>surgical treatment for<br>vaginal vault prolapse is<br>warranted. | Restorelle Y<br>Polypropylene Mesh is<br>indicated for use as a<br>bridging material for<br>sacrocolposuspension /<br>sacrocolpopexy<br>(laparotomy laparoscopic<br>or robotic approach)<br>where surgical treatment<br>for vaginal vault prolapse<br>is warranted. | Vertessa may be used<br>for the repair of uterine<br>or vaginal vault<br>prolapse that requires<br>support material. It<br>may be used in open or<br>laparoscopic abdominal<br>procedures. |
| Materials of<br>Construction | Non-absorbable,<br>monofilament<br>polypropylene mesh | Non-absorbable,<br>monofilament<br>polypropylene mesh | Non-absorbable,<br>monofilament<br>polypropylene mesh |
| Dimensions | 24x8cm | 24 x 4cm & 27 x 4cm | 12x20cm / Flat |
| Shape | Flat | Y | Flat |
| Pore Size (mm) | 1.80 x 1.83 | 1.80 x 1.83 | 1.47 x 0.64 |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Product Code | OTO | 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 L 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 L device.

Conclusions: The performance and non-clinical cited supporting this submission demonstrates that the Restorelle L is substantially equivalent to Restorelle Y and Vertessa Polypropylene Mesh.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 19, 2012

Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 5541 I

Re: K122440

Trade/Device Name: Restorelle® L Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 10, 2012 Received: October 11, 2012

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 vour 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.

ff 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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): K122440

Device Name: Restorelle® L

Indications for Use: Restorelle L is indicated for use as a bridging material for Indications for Use: Resiorene L Is millementomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.11.19 15:12:57,05500'

| (Division Sign-Off) | |
|----------------------------------------------------------------|---------|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K122440 |

Colopiast Restorelle L

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