POLYFORM SYNTHETIC MESH

K051245 · Proxy Biomedical , Ltd. · OTO · Jun 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051245
• Device Name: POLYFORM SYNTHETIC MESH
• Applicant: Proxy Biomedical , Ltd.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

Polyform™ Synthetic Mesh is a surgical implant for pelvic floor reconstruction; manufactured from monofilament polypropylene fibers; supplied sterile in sheet form. Surgeon cuts mesh to size and sutures it to fascial structures during abdominal surgery. Device provides mechanical support or bridging for fascial defects. Used in clinical/surgical settings by surgeons. Benefits include stabilization of pelvic floor tissues.

Clinical Evidence

Bench testing only. Mechanical and material characterization values compared to predicates. Biocompatibility testing performed. Rodent study data cited for comparison of technical properties to contemporary materials like Gynemesh PS.

Technological Characteristics

Monofilament polypropylene fibers; sheet form; sterile; mechanical support/bridging material. No software or electronic components.

Indications for Use

Indicated for patients requiring tissue reinforcement and stabilization of pelvic floor fascial structures via abdominal approach, serving as mechanical support or bridging material for fascial defects.

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

• Mersilene Mesh (Ethicon, Inc.)
• Prolene Soft Mesh (Ethicon, Inc.)
• Bard Mesh (C.R. Bard, Inc.)

Reference Devices

• Gynemesh PS

Submission Summary (Full Text)

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# 510(k) Summary

## SUBMITTED FOR:

| Company Name: | Proxy Biomedical, Ltd. |
|---------------|----------------------------------------------------------------------------------------|
| Address: | Coilleach, Spiddal<br>Galway, IRELAND<br>Caitriona Conneely, Quality Assurance Manager |

Tel: [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: PROCODE CLASS/REGULATION: FDA REVIEW PANEL:

Elaine Duncan September 4, 2012 (revised) Polyform™ Synthetic Mesh Surgical Mesh OTO Class II/21 CFR878.3300 Obstetrics/Gynecology

SUBSTANTIALLY EQUIVALENT TO: Polyform™ Synthetic Mesh is substantially equivalent to the Mersilene Mesh (Ethicon, Inc.), the Prolene Soft Mesh (Ethicon, Inc.), and the Bard Mesh (C.R. Bard, Inc.) a polypropylene mesh.

# DESCRIPTION of the DEVICE:

Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.

### INDICATIONS FOR USE:

Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

#### SUMMARY of TESTING:

Bench test data reveal Polyform™ Synthetic Mesh 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.Updated test data on the bench and the rodent, as summarized in the updated product brochure, shows comparable technical properties to the more contemporary material properties like those in the Gynemesh PS.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

OCT 25 2012

Proxy BioMedical, Ltd. % Elaine Duncan, M.S.M.E., RAC President Paladin Medical Incorporated P.O. Box 560 STILLWATER MN 55082-0560

Re: K051245

Trade/Device Name: Polyform™ Synthetic Mesh Regulation Number: 21 CFR § 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated (Date on orig SE Itr): May 11, 2005 Received (Date on orig SE ltr) : May 16, 2012

Dear Ms. Duncan:

This letter corrects our substantially equivalent letter of June 17, 2005.

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. Drue. and Cosmetic Act (Act) that do not require approval of a premarket approval (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 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 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/ReportalProblem/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.

Hubert Humphrey

Image /page/2/Picture/7 description: The image shows a handwritten signature. The signature is in cursive and appears to be a single word or name. The writing is dark and bold against a white background. The signature has a loop at the beginning and a flourish at the end.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Polyform™ Synthetic Mesh Device Name:

Indications for Use:

Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harlan Leess

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