MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH

K052100 · Proxy Biomedical , Ltd. · FTL · Aug 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052100
• Device Name: MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
• Applicant: Proxy Biomedical , Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MOTIFMESH ™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Device Story

MotifMesh Soft Tissue Patch is a non-absorbable, inert, porous surgical mesh made from expanded polytetrafluoroethylene (ePTFE). The device features a high-strength film with closed cell openings, allowing for bidirectional stretching to accommodate and reinforce tissue defects. It is used by surgeons in clinical settings to repair or reinforce hernia and fascial defects. The mesh promotes a fibroblastic response through its interstices, facilitating the formation of a fibrous wall to support tissue healing. The device is provided sterile.

Clinical Evidence

Bench testing only. Mechanical and material characterization testing demonstrated equivalence to the predicate. Biocompatibility testing confirmed the material is non-toxic and non-sensitizing.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Form: porous surgical patch, 0.006" +/- 0.001" thickness. Structure: high-strength film with sinusoidal closed cell openings. Sterilization: sterile. Energy source: none (passive implant).

Indications for Use

Indicated for patients requiring repair or reinforcement of hernia and other fascial defects needing nonabsorbable implant support during and after wound healing.

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

• MOTIFMESH™ Soft Tissue Patch (K050678)

Submission Summary (Full Text)

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K052100

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# AUG 1 1 2005

#### SECTION 1 510(k) Summary

## SUBMITTED FOR:

### Proxy Biomedical, Ltd.

Unit 6D, Mervue Business Park Galway, IRELAND Contact Person: Peter Mulrooney, Quality Assurance Manager

Tel: [phone] Fax: [phone]

Submitted by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

CONTACT PERSON: DATE PREPARED: TRADE NAME: COMMON NAME:

Elaine Duncan August 1, 2005 MOTIFMESHTM Soft Tissue Patch urgical Mesh

SUBSTANTIALLY EQUIVALENT TO: MOTIFMESH™ Soft Tissue Patch with the sinusoidal cell opening is substantially equivalent to the MOTIFMESH™ Soft Tissue Patch with the hexagonal shape previously cleared under K050678.

#### DESCRIPTION of the DEVICE:

Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.

#### INDICATIONS FOR USE:

MOTIFMESH ™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

#### SUMMARY of TESTING:

Bench test data reveal MOTIFMESH TM Soft Tissue Patch has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with their intended use.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Proxy Biomedical, Ltd. c/o Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082-0560

Re: K052100

Trade/Device Name: Modification to Motif Mesh Soft Tissue Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 1, 2005 Received: August 3, 2005

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave acterimerally marketed predicate devices marketed in interstate for use stated in the clerosure) to regarly nameted to of the Medical Device American procession of to conniferee prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassinod in accerative who f a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require appt to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the recess 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 If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to suell additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods of reacts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr o locality a your device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must of any I cacial statuted and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 81equirements, and manufacturing practice requirements as set CFR Part 877, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2- Ms. Elaine Duncan, M.S.M.E., RAC

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,

Barbara Brigham

Mark N. Melkerson Acting 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

510(k) Number (if known):_____K052100

Modification to Motif Mesh Soft Tissue Patch Device Name:

'

Indications For Use:

Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

تتخذ بدر

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saulare Buchus

Division of General, Restorative. and Neurological Devices

510(k) Number K052100

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