GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL

K032168 · W. L. Gore & Associates, Inc. · FTL · Aug 15, 2003 · General, Plastic Surgery

Device Facts

Record IDK032168
Device NameGORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
ApplicantW. L. Gore & Associates, Inc.
Product CodeFTL · General, Plastic Surgery
Decision DateAug 15, 2003
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.3300
Device ClassClass 2
AttributesTherapeutic

Intended Use

GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

Device Story

Surgical mesh device; consists of ePTFE mesh coated with silver carbonate and chlorhexidine diacetate; silicone component attached to closed microstructure side via silicone adhesive. Silicone component provides stiffness and improved handling/unrolling characteristics for easier placement and fixation. Used by surgeons in clinical settings for hernia repair and soft tissue reconstruction. Device provides structural support for tissue defects.

Clinical Evidence

Bench testing only. Device integrity testing performed to demonstrate equivalence to predicate devices; all results met specified requirements.

Technological Characteristics

Materials: ePTFE mesh, silver carbonate, chlorhexidine diacetate, silicone component, silicone adhesive. Form factor: Mesh with attached stiffening component. Sterilization: Not specified.

Indications for Use

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

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Special 510(k) Premarket Notification K032168 AUG 15 2003 GORE-TEX DualMesh EMERGE PLUS Biomaterial (p.1 of 2) # 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE | Proprietary Name: | GORE-TEX DualMesh EMERGE PLUS Biomaterial | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Surgical Mesh | | Classification Name: | Surgical Mesh | | Device Classification: | Class II | | Product Classification and Code: | 878.3300, FTL | | Classification Panel: | General and Plastic Surgery Devices | | Establishment Registration Number: | 2025240 | | Contact Person: | Brandon Hansen<br>Regulatory Affairs<br>Medical Products Division<br>W.L. Gore & Associates, Inc.<br>3450 West Kiltie Lane<br>Flagstaff, AZ 86001<br>Telephone: (928) 864-3784<br>Facsimile: (928) 864-4144<br>E-mail: bhansen@wlgore.com | ### Performance Standards Performance standards do not currently exist for these devices. None established under Section 514. #### Device Description The GORE-TEX DualMesh EMERGE PLUS Biomaterial consists of an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive. The silicone component is designed to provide a stiffening {1}------------------------------------------------ Special 510(k) Premarket Notification K432168 (4.2 a 2) K032168 GORE-TEX DualMesh EMERGE PLUS Biomaterial effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component. #### Indication for Use GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects. #### Substantially Equivalent Devices In W.L. Gore & Associates' opinion, the GORE-TEX DualMesh EMERGE PLUS Biomaterial is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use. - GORE-TEX DualMesh EMERGE and EMERGE PLUS Biomaterial (W.L. Gore & � Associates, Inc., Flagstaff, AZ) -- K022782 - GORE-TEX DualMesh PLUS Biomaterial (W.L. Gore & Associates, Inc., Flagstaff, AZ) -. K000185, K981051, K965038, K946106 Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from that of the predicate devices listed above. #### Summary of Studies W.L. Gore & Associates, Inc. performed device integrity testing to support that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to the predicate devices. All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements. ### Conclusion (Statement of Equivalence) Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the W. L. Gore & Associates, Inc. GORE-TEX DualMesh EMERGE PLUS Biomaterial through this Special 510(k) Premarket Notification. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 5 2003 Mr. Brandon Hansen Regulatory Affairs W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86001 Re: K032168 Trade/Device Name: GORE-TEX DualMesh EMERGE PLUS Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 15, 2003 Received: July 17, 2003 #### Dear Mr. Hansen: 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 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. {3}------------------------------------------------ Page 2 - Mr. Brandon Hansen 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Alan Webb Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Special 510(k) Premarket Notification K032168 GORE-TEX DualMesh EMERGE PLUS Biomaterial ## INDICATION FOR USE 510(k) Number (if known): 432168 Device Name: GORE-TEX DualMesh EMERGE PLUS Biomaterial Intended Use / Indication For Use: GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number [032
Innolitics
510(k) Summary
Decision Summary
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