VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH

K111121 · Proxy Biomedical , Ltd. · FTL · May 13, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111121
• Device Name: VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
• Applicant: Proxy Biomedical , Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VitaMesh™ Blue Lightweight Macroporous PP 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™ Blue Lightweight Macroporous PP Surgical Mesh is a non-absorbable, synthetic surgical mesh designed for hernia and fascial defect repair. It is a modification of the predicate VitaMesh™ (K060520), featuring an added blue colorant for enhanced visibility and a more open, thinner weave for improved drapeability and a lighter texture. The device provides mechanical support to tissues during and after the wound healing process. It is intended for use by surgeons in clinical settings. The device is implanted to reinforce weakened fascial structures, potentially improving patient outcomes in hernia repair procedures.

Clinical Evidence

Bench testing performed per 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' (March 2, 1999). Additional qualification included biocompatibility testing and a comparative animal implant study, which showed comparable safety performance and equivalent healing properties to the predicate device.

Technological Characteristics

Non-absorbable, synthetic polypropylene (PP) surgical mesh. Features an open weave, reduced thickness, and blue colorant. Class II device (21 CFR 878.3300).

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

• VitaMesh™ surgical mesh (K060520)

Submission Summary (Full Text)

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K 11 1121
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MAY 1 3 2011

## SPECIAL 510(k)

Submitter- Manufacturer: Proxy Biomedical Ltd.,

Denise Kennedy ,Quality Assurance Manager

Coilleach, Spiddal, Galway, Ireland. Tel: + 353 91 896900 30048-59928

Submitted by and Contact Person

Elaine Duncan Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

CONTACT PERSON:

Elaine Duncan

DATE PREPARED:

April 14, 2011

TRADE NAME: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh (and as also known by various other trade names)

Surgical Mesh COMMON NAME: Surgical Mesh Polymeric CLASSIFICATION NAME: 21 CFR 878.330D REGULATION General and Plastic Surgery, FTL: Class II PROCODE and CLASS

SUBSTANTIALLY EQUIVALENT TO: VitaMesh™ Blue Lightweight Macroporous PP Mesh is a modification of and is therefore substantially equivalent to VitaMesh™ surgical mesh, cleared under K060520. The addition of a colorant (blue) and modifications to the mesh physical properties do not introduce new risks nor do they affect the fundamental performance of the predicate product.

DESCRIPTION of the DEVICE: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.

INDICATIONS FOR USE: VitaMesh™ Blue Lightweight Macroporous PP 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: Design verification tests were per the requirements of 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, March 2, 1999' and showed comparable properties to the VitaMesh. Additional qualification testing included biocompatibility and animal implant comparative study which showed comparable safety performance and equivalent healing properties when compared to predicate product.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and the USA. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Proxy Biomedical, Ltd. % Paladin Medical, Inc. Ms. Elaine Duncan P.O. Box 560 Stillwater, Minnesota 55082

1 3 2011 MAY

Re: K111121

Trade/Device Name: VitaMesh" Blue Lightweight Macroporous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2011 Received: April 21, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not-misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Elaine Duncan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Thy B. Rh

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K111121 . 510(k) Number (if known):

## Device Name: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh

Indications for Use:

VitaMesh™ Blue Lightweight Macroporous PP 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 _ 2

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kume for MXM
(Division Sign-Off)

Division S (Division of Surgical, Orthopedic, d Restorative Devices

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510(k) Number K11121