RESTORELLE M, RESTORELLE XL

K132061 · Coloplast Corp. · OTO · Aug 2, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132061
• Device Name: RESTORELLE M, RESTORELLE XL
• Applicant: Coloplast Corp.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Aug 2, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restorelle M and Restorelle XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension and/or sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Story

Restorelle M and XL are sterile, non-absorbable, knitted monofilament polypropylene surgical meshes. Designed for use by surgeons in clinical settings (OR) to treat apical vaginal prolapse. Function as bridging material during sacrocolposuspension or sacrocolpopexy procedures performed via laparotomy, laparoscopy, or robotic surgery. Restorelle M measures 10cm x 15cm; Restorelle XL measures 30cm x 30cm. Devices provide structural support to pelvic floor tissues to correct prolapse. Clinical benefit derived from mechanical reinforcement of vaginal vault.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Non-absorbable, monofilament polypropylene mesh; flat form factor; pore size 1.80 x 1.83 mm; dimensions 10cm x 15cm (M) and 30cm x 30cm (XL); sterilized via ethylene oxide.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal vault prolapse; used as 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 L (K122440)

Submission Summary (Full Text)

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2 2013

AUG

## 2. 510(k) Summary

| 510(k) Owner's Name: | Coloplast A/S | |
|----------------------------|---------------------------------------------------------------------------------------------------------|--|
| Address: | Holtedam 1<br>3050 Humlebaek, Denmark<br>Establishment Registration: 9610694<br>Owner/Operator: 8010144 | |
| Phone/Fax: | Office: [phone]<br>Fax: [phone] | |
| Name of Contact Person: | Tim Crabtree<br>Regulatory Affairs Manager | |
| Date Prepared: | July 2, 2013 | |
| Trade or Proprietary Name: | Restorelle M & XL Polypropylene Mesh | |
| Common or Usual Name: | Surgical Mesh | |
| Classification Name/ | Mesh, Surgical, Gynecological, For Apical Vaginal<br>Prolapse, Transabdominally Placed | |
| CFR Number/Product Code: | 21 CFR §878.3300/ OTO | |
| Predicate Devices: | Restorelle L (K122440) | |

Description of Device: Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.

Indication for Use: Restorelle M and Restorelle XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension and/or sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Technological Characteristics Summary: The Coloplast Restorelle M and Restorelle XL Polypropylene Mesh devices share the same materials, features, intended use, and technological characteristics as Restorelle L. The following table lists the properties associated with the subject and predicate devices.

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| Property | Subject Devices<br>Restorelle M & XL | Predicate Device<br>Restorelle L |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Restorelle M & XL<br>Polypropylene Mesh devices<br>are indicated for use as bridging<br>material for<br>sacrocolposuspension /<br>sacrocolpopexy (laparotomy<br>laparoscopic or robotic<br>approach) where surgical<br>treatment for vaginal vault<br>prolapse is warranted | Restorelle L Polypropylene<br>Mesh is indicated for use as<br>bridging material for<br>sacrocolposuspension/<br>sacrocolpopexy (laparotomy,<br>laparoscopic, or robotic<br>approach) where surgical<br>treatment for vaginal vault<br>prolapse is warranted |
| Materials of<br>Construction | Non-absorbable, monofilament<br>polypropylene mesh | Non-absorbable, monofilament<br>polypropylene mesh |
| Dimensions | 10cm x 15cm (M)<br>30cm x 30cm (XL) | 24cm x 8cm (L) |
| Shape | Flat | Flat |
| Pore Size (mm) | 1.80 × 1.83 | 1.80 x 1.83 |
| Sterilization<br>Method | Ethylene Oxide | Same |
| Regulatory<br>Status | Pending | Cleared K122440 (L) |
| Product Code | OTO | OTO |

The only difference in between the subject and predicate devices is the mesh size. Therefore the proposed subject device is substantially equivalent to the referenced predicate devices for indications, materials and technological features.

Conclusions: The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh.

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Public Health Service

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

August 2, 2013

Coloplast A/S % Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road Minneapolis, MN 55411

Re: K132061

Trade/Device Name: Restorelle M and Restorelle XL Polypropylene Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: July 2, 2013 Received: July 3, 2013

Dear Tim 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Tim Crabtree

(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 (OS) 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 contact 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. 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,

## Herbert P. Lerner -S

for

Beniamin 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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1. Statement of Indications for Use

## Indications for Use

510(k) Number (if known): _ K132061

Restorelle M and Restorelle XL Polypropylene Mesh Device Name:

Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Prescription Use **X**

Over-The-Counter Use ------

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:

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(Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P., Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K132061 510(k) Number_

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