PREVADH MESH

K073287 · Sofradim Production · FTL · Mar 13, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073287
• Device Name: PREVADH MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.

Device Story

PREVADH™ Mesh is a sterile, fully resorbable surgical mesh designed for temporary wound support in abdominopelvic surgery. Device consists of three layers: a porous side of lyophilized porcine collagen for tissue in-growth; a non-porous smooth side of porcine collagen, polyethylene glycol, and glycerol to minimize visceral attachment; and a central multifilament polylactic acid mesh for mechanical strength. Device is implanted by surgeons during abdominopelvic procedures. The porous collagen layer resorbs within one week, the non-porous layer within three weeks, and the polylactic acid mesh provides support for at least 12 weeks during the healing period. By separating the mesh from adjacent organs, the device reduces the risk of visceral adhesions. The device is intended for use in clinical settings by qualified healthcare professionals.

Clinical Evidence

No clinical data provided. Evidence consists of bench and animal testing to evaluate mechanical properties and performance characteristics. Mechanical testing results indicate performance similar to the VICRYL Mesh predicate.

Technological Characteristics

Three-layer resorbable surgical mesh: porous porcine collagen foam, multifilament polylactic acid mesh, and non-porous hydrophilic porcine collagen/polyethylene glycol/glycerol film. Materials comply with ISO 10993-1 and USP standards. Large-pore knitted design facilitates tissue in-growth. Device is fully resorbable.

Indications for Use

Indicated for patients requiring temporary wound support during abdominopelvic surgery.

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

• PARIETEX™ COMPOSITE (PCO) Mesh (K040998)
• VICRYL Mesh (K810428)
• UGYTEX™ Mesh (K033376)

Submission Summary (Full Text)

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K073287
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## MAR J 3 2008 510(k) Summary of Safety and Effectiveness

- SUBMITTER: Sofradim Production 116, avenue du formans 01600 Trevoux, France Phone: [phone] CONTACT PERSON: Sharon Alexander Senior Associate, Regulatory Affairs Covidien 60 Middletown Avenue North Haven, CT 06473 USA Phone: [phone] DATE PREPARED: November 20, 2007 TRADE/PROPRIETARY NAME: PREVADH™ Mesh COMMON/USUAL NAME: Surgical Mesh CLASSIFICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): PARIETEX™ COMPOSITE (PCO) Mesh (K040998) Ethicon, Inc. VICRYL Mesh (K810428) UGYTEX™ Mesh (K033376) DEVICE DESCRIPTION: PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period. INTENDED USE: PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera. TECHNOLOGICAL CHARACTERISTICS: The technological characteristics of PREVADH™ Mesh are similar to those of the predicate devices. PREVADH™ Mesh is manufactured from three resorbable components: porous collagen foam, polylactic acid mesh, and a hydrophilic collagen

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PREVADH™ Mesh

film. PREVADH™ Mesh is knitted in a design with large pores that allow fast tissue in-growth. The collagen-based components of PREVADH™ Mesh are derived from a porcine source already cleared by FDA for predicate PARIETEX™ COMPOSITE (PCO) Mesh (K040998). As with this predicate PCO Mesh, the hydrophilic collagen film serves to temporarily separate the mesh from adjacent organs to minimize visceral attachment to the mesh which may occur during the healing process.

MATERIALS: PREVADH™ Mesh is comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards.

- PERFORMANCE DATA: Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh. Results of mechanical properties testing show that PREVADH™ Mesh has similar performance characteristics to the predicate VICRYL Mesh.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Sofradim Production % Covidien Ms. Sharon Alexander Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K073287

Trade/Device Name: PREVADH™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 15, 2008 Received: February 19, 2008

Dear Ms. Alexander:

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 - Ms. Sharon Alexander

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M Millman

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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PREVADH™ Mesh

## Indications For Use

510(k) Number (if known): {_c 7 328

Device Name: PREVADH™ Mesh

Indications For Use:

PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.

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 IF NEEDED)

RH, Office of Device Evaluation (ODE) Concurre (Division Sign-Off Division of General, Restorative.

and Neurological Devices

**510(k) Number** K073287