MENTOR NOVASILK MESH

K053414 · Mentor Corp. · OTP · Dec 27, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K053414
• Device Name: MENTOR NOVASILK MESH
• Applicant: Mentor Corp.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Mentor NovaSilk Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

Mentor NovaSilk Mesh is a permanent, synthetic, knitted polypropylene surgical mesh. Device is square-shaped, sterile, and intended for single use. Used by surgeons for pelvic floor reconstruction; provides mechanical support or bridging for fascial defects in vaginal wall prolapse cases. Device functions as a physical implant to reinforce weakened tissue structures. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. Assessments included product dimensions (fiber/pore size), density, porosity, burst and tear strength, tensile elongation, stiffness, suture pull strength, and edge integrity. Biocompatibility testing confirmed the device is non-toxic and non-pyrogenic.

Technological Characteristics

Permanent, synthetic, knitted polypropylene surgical mesh. Square form factor. Sterile, single-use. Mechanical properties assessed include density, porosity, burst/tear strength, tensile elongation, stiffness, and suture pull strength. No energy source, connectivity, or software.

Indications for Use

Indicated for tissue reinforcement and stabilization of pelvic floor fascial structures in patients with vaginal wall prolapse requiring surgical treatment, serving as mechanical support or bridging material for fascial defects.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• Gynemesh Prolene Soft (Polypropylene) Mesh (K013718)
• Aris Sling (K050148)

Submission Summary (Full Text)

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K053414/1/2

# DEC 2 7 2005

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Donna A. Crawford Contact Person: Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111

805-879-6304 Telephone: [phone] FAX:

December 2, 2005 Date Prepared:

## Device Name and Classification

| Proprietary Name: | Mentor NovaSilk™ Mesh |
|----------------------|--------------------------|
| Common Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, polymeric |
| Class: | Class II |
| Product Code: | OTP, PAI, OTO, PAJ |
| CFR #: | §878.3300 |

#### Device Description

NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.

#### Substantial Equivalence Claim

The Mentor NovaSilk Mesh is substantially equivalent in material, function, performance and design to the Gynemesh Prolene Soft (Polypropylene) Mesh that was cleared under 510(k) K013718. Knitted polypropylene is currently used in Mentor's Aris Sling which was cleared under 510(k) K050148.

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Image /page/1/Picture/0 description: The image shows a handwritten text string that appears to be an identifier or code. The text reads 'K.053411Y' with a subscript of '2/2' next to the 'Y'. The writing is in a dark ink, contrasting with the white background, and has a casual, handwritten style.

#### Indications for Use

The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.

### Summary of Testing

The following characteristics were assessed for NovaSilk: overall product dimensions, including fiber and pore sizes; density and porosity; burst and tear strength; tensile morating the elongation; stiffness; suture pull strength; and edge integrity and curling.

The following biocompatibility testing was performed on NovaSilk: pyrogenicity, The forlowing orocompanentic toxicity. NovaSilk has been demonstrated to be nontoxic and non-pyrogenic.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

SEP 2 8 2012

Re: K053414 Trade/Device Name: Mentor NovaSilk Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, OTO, PAJ Dated: December 2, 2005 Received: December 7, 2005

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of December 27, 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, Drug, 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 of medical device-related adverse events) (21 CFR 803); 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.

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" (21 CFR 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,

Sincerely yours,

Benjamin R. Weeks

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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K053414

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Mentor NovaSilk™M Mesh

Indications for Use:

....

The Mentor NovaSilk Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical trealment 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)

Sartine BreuilD

and Ne

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**510(k) Number** K063414