VITAMESH MACROPOROUS PP SURGICAL MESH

K060520 · Proxy Biomedical , Ltd. · FTL · Mar 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060520
• Device Name: VITAMESH MACROPOROUS PP SURGICAL MESH
• Applicant: Proxy Biomedical , Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Proxy Biomedical VITAMESH™ surgical mesh 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

VITAMESH™ is a non-absorbable, synthetic surgical mesh constructed of knitted polypropylene filaments. Supplied sterile in sheet form, it is cut to size and sutured by surgeons in clinical settings to repair or reinforce hernia and fascial defects. The mesh structure promotes a fibroblastic response through its interstices, facilitating the formation of a strong fibrous wall. It provides elasticity in two directions and exhibits high burst and tensile strength. The device serves as a permanent implant to provide mechanical support during and after the wound healing process.

Clinical Evidence

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

Technological Characteristics

Non-absorbable synthetic mesh; material: knitted polypropylene filaments; form factor: sheet (approx. 0.010" thick); mechanical properties: elastic in two directions, high burst and tensile strength; sterilization: sterile supply.

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

• Bard PTFE Mesh (Davol Inc.)
• Mersilene Mesh (Ethicon, Inc.)
• Bard Mesh (C.R. Bard, Inc.)

Submission Summary (Full Text)

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MAR 2 8 2006

K060520
Page 1 of 1

#### SECTION 1 510(k) Summary

# SUBMITTED FOR:

| Company Name: | Proxy Biomedical, Ltd. |
|--------------------------------|------------------------------------------------------------|
| Address: | 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: | Elaine Duncan |
| DATE PREPARED: | Feb 11, 2006 |
| TRADE NAME: | VITAMESH™ |
| COMMON NAME: | Surgical Mesh |
| REGULATORY CLASS: | This device is class II |
| DEVICE PANEL AND PRODUCT CODE: | General and Plastic Surgery<br>21 CFR 878.330 FTI |

SUBSTANTIALLY EQUIVALENT TO: VITAMESH™ is substantially equivalent to the Bard PTFE Mesh. (Davol Inc.),Mersilene Mesh (Ethicon, Inc.), and the Bard Mesh (C.R. Bard, Inc.) a polypropylene mesh.

# DESCRIPTION of the DEVICE:

The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.

## INDICATIONS FOR USE:

Proxy Biomedical VITAMESH™ surgical mesh 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 demonstrate that VITAMESH™ 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 nonsensitizing to biological tissues consistent with their intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2006

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

Re: K060520

Trade/Device Name: VITAMESH™ MacroPorous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 23, 2006 Received: February 27, 2006

Dear Ms. Duncan:

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 docs 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. Elaine Duncan, M.S.M.E., RAC

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 vours.

Hubert Lemmer MD

\$

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

KO60520 510(k) Number (if known):

Device Name: VITAMESH™ MacroPorous PP Surgical Mesh

Indications For Use:

Proxy Biomedical VITAMESH™ surgical mesh 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lemons

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K060520

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