PROCEED SURGICAL MESH

K060713 · ETHICON, Inc. · FTL · May 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060713
• Device Name: PROCEED SURGICAL MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh for hernia and fascial deficiency repair. Device consists of oxidized regenerated cellulose (ORC) fabric and PROLENE Soft Mesh (nonabsorbable polypropylene) encapsulated by a polydioxanone polymer. Polypropylene side facilitates tissue ingrowth; ORC side provides a bioresorbable layer to physically separate mesh from underlying tissue/organs during wound healing, minimizing tissue attachment. Polydioxanone bonds the ORC layer. Used by surgeons in clinical settings to reinforce or bridge tissue defects.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics to the predicate device.

Technological Characteristics

Laminate mesh composed of oxidized regenerated cellulose (ORC) fabric, PROLENE Soft Mesh (polypropylene), and polydioxanone polymer. Sterile, thin, flexible form factor. No electronic or software components.

Indications for Use

Indicated for patients requiring hernia repair or repair of fascial deficiencies needing reinforcing or bridging material.

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

• PROCEED Trilaminate Surgical Mesh

Submission Summary (Full Text)

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MAY 2 5 2006

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## SECTION 5 – 510(K) SUMMARY

| 510(k) Summary | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Ethicon Inc., a Johnson and Johnson Company |
| Contact Information | Sergio J. Gadaleta, Ph.D.<br>Director, Worldwide Regulatory Affairs<br>Ethicon Inc., a Johnson & Johnson Company<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876<br>Telephone: [phone]<br>Facsimile: 908-218-2595<br>e-mail: [e-mail] |
| Date | March 10, 2006 |
| Trade Name | PROCEED Surgical Mesh |
| Common Name | Surgical Mesh |
| Classification Name | Surgical Mesh<br>Regulation Number: 878.3300<br>Product Code: FTL |
| Predicate Device | PROCEED Trilaminate Surgical Mesh |
| Device Description | PROCEED Surgical Mesh is a sterile, thin,<br>flexible laminate mesh deigned for the repair<br>of hernias and other fascial deficiencies. The<br>mesh product is comprised of an oxidized<br>regenerated cellulose (ORC) fabric, and<br>PROLENE* Soft Mesh, a nonabsorbable<br>polypropylene mesh, which is encapsulated by<br>a polydioxanone polymer. The polypropylene |
| | KO60713<br>2 of 2 |
| | mesh side of the product allows for tissue<br>ingrowth while the ORC side provides a<br>bioresorbable layer that physically separates the<br>polypropylene mesh from underlying tissue<br>and organ surfaces during the wound-healing<br>period to minimize tissue attachment to the<br>mesh. The polydioxanone provides a bond to<br>the ORC layer. |
| Intended Use | PROCEED Mesh may be used for the repair<br>of hernias and other fascial deficiencies that<br>require the addition of a reinforcing or<br>bridging material to obtain the desired surgical<br>result. |
| Technological Characteristics | The technological characteristics of<br>PROCEED Surgical Mesh are identical to the<br>predicate device, PROCEED SURGICAL<br>Mesh. |
| Conclusions | The descriptive information provided about<br>PROCEED Surgical Mesh demonstrates<br>substantial equivalence to the predicate device. |

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

Ethicon Inc., a Johnson & Johnson Co. % Sergio J. Gadaleta, Ph.D. Director, Worldwide Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876

Re: K060713

Trade/Device Name: PROCEED Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 10, 2006 Received: May 11, 2006

Dear Dr. Gadaleta:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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## Page 2 - Sergio J. Gadaleta, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,
Mike A Millhurn

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

Enclosure

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## SECTION 4 – INDICATIONS FOR USE STATEMENT

5071

510(k) Number (if known): _ Device Name: PROCEED Surgical Mesh Indications for Use:

PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desiréd surgical result.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

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)

> > Page 1 of 1

Mark A. Millican

ision Sign-Division of General. Restorative and Neurological Devices

Number: K060713

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