RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

K103568 · Coloplast A/S · FTL · Dec 22, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103568
• Device Name: RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
• Applicant: Coloplast A/S
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Device Story

Restorelle is a non-absorbable, warp-knitted surgical mesh made from extruded polypropylene monofilaments. Designed for surgical repair of abdominal wall hernias and fascial deficiencies; provides structural support to tissues. The knitted construction allows cutting to desired size/shape without unraveling and provides isotropic mechanical properties. Used by surgeons in open, laparoscopic, or vaginal procedures. Device is supplied sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro (bench) testing, including retention, mechanical, and mass density testing, demonstrating the device's ability to withstand stresses encountered during clinical use.

Technological Characteristics

Non-absorbable polypropylene monofilament mesh; warp-knit construction; isotropic properties; supplied sterile. No specific ASTM standards cited.

Indications for Use

Indicated for patients requiring surgical repair of abdominal wall hernias (inguinal, femoral, incisional), uterovaginal prolapse, or other fascial deficiencies requiring support material. Suitable for open, laparoscopic, or vaginal route procedures.

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 (K092207)
• Minimesh (K041632)
• Minimesh (K053361)

Submission Summary (Full Text)

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KIOSS68 レ.. . .

Image /page/0/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into horizontal lines, with the bottom half being solid black and the top half being white lines on a black background. The word "Coloplast" is written in a bold, sans-serif font.

## 3 510(k) Summary

'

DEC 2 2 2010

:

| 510(k) Owner/SUBMITTER | Coloplast A/S |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | Holtedam 1 |
| | Humlebaek 3050 - Denmark |
| CONTACT PERSON | Janell A. Colley |
| | Coloplast Corp |
| | 1601 West River Road North |
| | Minneapolis, Minnesota 55411 USA |
| DATE PREPARED | 20 December 2010 |
| CLASSIFICATION | Polymeric Surgical Mesh (Product Code FTL) is a Class II device per 21 CFR<br>878.3300 |
| COMMON NAME | Polymeric Surgical Mesh |
| PROPRIETARY NAME | Restorelle™ polypropylene mesh |
| PREDICATE DEVICE | K092207 - Restorelle |
| | K041632 & K053361 - Minimesh (Mpathy Medical Ltd) |
| DEVICE DESCRIPTION | Restorelle is a non-absorbable polypropylene mesh constructed from knitted |
| | monofilaments of extruded polypropylene. |
| | Restorelle polypropylene mesh is constructed using a warp-knit process that |
| | permits the mesh to be cut into desired shape or size without unraveling. |
| | It maintains excellent isotropic properties arising from its knitted construction. |
| | Restorelle polypropylene mesh has the necessary strength, flexibility, |
| | durability and surgical adaptability properties which permit the correct |
| | adaptation to the various stresses encountered in the body. |
| | The device is supplied sterile. |
| INDICATIONS | Restorelle polypropylene mesh may be used for the repair of abdominal wall |
| | hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse |
| | and other fascial deficiencies that require support material. It may be used in |
| | open or laparoscopic abdominal procedures or for repair by the vaginal route. |
| TESTING | The components of the Restorelle device have been subjected to |
| | biocompatibility and mechanical testing and are substantially equivalent to the |
| | predicate Restorelle (K092207) and Minimesh devices (K041632 & K053361). |
| TECHNOLOGICAL<br>CHARACTERISTICS | Restorelle polypropylene mesh has the same intended use, general design, |
| | material and fundamental scientific technology as the predicate Restorelle |
| Summary Of The Nonclinical<br>Tests Submitted | polypropylene mesh device (K092207).<br>In vitro (bench) tests: Retention, Mechanical, Mass density testing |
| Summary Of Clinical Tests<br>Submitted (As Applicable) | Not applicable |
| Conclusions Drawn From The<br>Nonclinical And Clinical Tests | The device has been subjected to in-vitro testing which demonstrate the |
| | ability of the device to adequately permit correct adaptation to the various |
| | stresses encountered in the body during normal clinical use. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three flowing lines representing its body and wings. To the left of the bird is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Coloplast A/S % Coloplast Corporation Ms. Janell A. Colley 1601 West River Road N Minneapolis, Minnesota 55411

DEC 2 2 200

Re: K103568

Trade/Device Name: Restorelle Polypropylene Mesh Regulation Number: 21 CFR 878,3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 3, 2010 Received: December 6, 2010

Dear Ms. Colley:

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. Iisting 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

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Page 2 - Ms. Janell A. Colley

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 vours.

AK B. Nh

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image contains the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is made up of several horizontal lines that are stacked on top of each other. The word "Coloplast" is written in a bold, sans-serif font.

DEC 2 2 2010

## Statement of Indications for Use 2

## Indications for Use

510(k) Number (if known):

K103568

Device Name:

Restorelle Polypropylene Mesh

Indications for Use:

Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Prescription Use **X**

Over-The-Counter Use

(Part 2) CFR 80T Subpart D)

AND/OR (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number /C103568