SURGIMESH XB

K072974 · Aspide Medical · FTL · Aug 18, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072974
• Device Name: SURGIMESH XB
• Applicant: Aspide Medical
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair. The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.

Device Story

SURGIMESH®XB is a non-absorbable, non-knitted, non-woven polypropylene surgical mesh with a silicone coating on one side. Used by surgeons in clinical settings for hernia repair, soft tissue reconstruction, and fascial defect bridging. The mesh provides structural reinforcement to tissues; the silicone layer acts as a barrier to minimize tissue attachment when in direct contact with viscera. Supplied sterile in various anatomic forms to accommodate patient-specific surgical requirements.

Clinical Evidence

Bench testing only. Biocompatibility results demonstrate the material is non-toxic and non-sensitizing to biological tissues.

Technological Characteristics

Non-absorbable synthetic mesh; non-knitted, non-woven polypropylene fibers; one surface coated with silicone. Supplied sterile. Available in anatomic forms. Class II device.

Indications for Use

Indicated for reconstruction of hernias, soft tissue deficiencies, and temporary bridging of fascial defects in patients requiring surgical tissue reinforcement.

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

• ASPIDE MEDICAL SURGIMESH®WN (K061445)
• Sofradim Production's Parietex Composite mesh (K040998)
• AMS triangle silicone-coated sling (K002721)
• Gore-Tex® DualMesh® PLUS Biomaterial with Holes (K010228)
• Davol Inc., Bard® Soft Mesh (K033814)
• Davol Inc., Bard Composix® L/P Mesh (K061754)

Submission Summary (Full Text)

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K072974
pg 1082

## 510(k) SUMMARY

## Aspide Medical's SURGIMESH®XB

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ASPIDE MEDICAL Impasse George SAND 246 Allée LAVOISIER 42350 LA TALAUDIERE (FRANCE)

Phone: [phone] Facsimile: [phone]

Contact Person: Mr. William WIECEK

Date Prepared: August 8, 2008

# Name of Device and Name/Address of Sponsor

## SURGIMESH®XB

ASPIDE MEDICAL Impasse George SAND 246 Allée LA VOISIER 42350 LA TALAUDIERE (FRANCE)

## Common or Usual Name

Polymeric Surgical Mesh

## Classification Name

Surgical Mesh Product Code: FTL Regulation Number: 21 C.F.R. 878.3300

# Predicate Devices

- (1) ASPIDE MEDICAL SURGIMESH®WN (K061445)
- (2) Sofradim Production's Parietex Composite mesh (K040998)
- (3) AMS triangle silicone-coated sling (K002721)
- (4) Gore-Tex® DualMesh® PLUS Biomaterial with Holes (K010228)
- (5) Davol Inc., Bard® Soft Mesh (K033814)
- (6) Davol Inc., Bard Composix® L/P Mesh (K061754)

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# AUG 1 8 2008

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## Intended Use / Indications for Use

The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.

The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.

### Technological Characteristics

The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.

## Performance Data

The SURGIMESH®XB mesh's mechanical and material characteristics are substantially equivalent to its predicate devices. The biocompatibility results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues when used as intended

## Substantial Equivalence

The SURGIMESH®XB is as safe and effective as the (1) the ASPIDE MEDICAL SURGIMESH®WN; (2) the Sofradim Production's Parietex Composite mesh; (3) the AMS triangle silicone-coated sling; (4) the Gore-Tex® DualMesh® PLUS Biomaterial with Holes; (5) the Davol Inc., Bard® Soft Mesh; and (6) the Duvol Inc., Bard® Composix® L/P Mesh. The SURGIMESH®XB has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the SURGIMESH®XB and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SURGIMESH®XB is as safe and effective as (1) the ASPIDE MEDICAL SURGIMESH®WN; (2) the Sofradim Production's Parietex Composite mesh; (3) the AMS triangle silicone-coated sling; (4) the Gore-Tex® DualMesh® PLUS Biomaterial with Holes; (5) the Davol Inc., Bard® Soft Mesh; and (6) the Davol Inc., Bard® Composix® L/P Mesh. Thus, the SURGIMESH®XB is substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aspide Meccal % Hogan & Hartson, LLP Mr. Howard M. Holstein, Esq. Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

AUG 1 8 2008

Re: K072974

Trade/Device Name: SURGIMESH®XB Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 8, 2008 Received: August 8, 2008

Dear Mr. Holstein:

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

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and a ribbon flowing beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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Page 2 - Mr. Howard M. Holstein, Esq.

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. Mulkerson

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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## Indications for Use Statement

510(k) Number (if known):

Device Name: SURGIMESH®XB

Indications for Use:

The SURGIMESH®XB is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Malkuss

Division of Ge and New 510(k) Number