NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015

K122968 · Coloplast Corp. · OTO · Dec 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122968
• Device Name: NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
• Applicant: Coloplast Corp.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Story

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh; manufactured from knitted, monofilament polypropylene. Device is square (150mm x 150mm) and 0.25mm thick. Used by surgeons during sacrocolposuspension/sacrocolpopexy procedures (laparotomy, laparoscopic, or robotic) to treat vaginal vault prolapse. Acts as a bridging material to provide structural support to the vaginal vault. Benefits include permanent reinforcement of pelvic floor tissues.

Clinical Evidence

No clinical data. Substantial equivalence is based on design verification, biocompatibility, sterilization, and shelf-life testing performed on the predicate device.

Technological Characteristics

Implantable, permanent, non-resorbable, synthetic support mesh. Material: knitted, monofilament polypropylene. Dimensions: 150mm x 150mm, 0.25mm thick. Form factor: square sheet.

Indications for Use

Indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) in patients requiring surgical treatment for vaginal vault prolapse.

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

• NovaSilk Mesh, Coloplast (K053414)
• Vertessa, Caldera Medical (K120327)

Submission Summary (Full Text)

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K122968 Page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is made up of horizontal lines that are thicker at the bottom and thinner at the top. The word "Coloplast" is in a bold, sans-serif font.

Ostomy Care Urology & Continence Care Wound & Skin Care

#### 510(k) Summary

**DEC 1 8 2012**

| Submitter: | ColoplastA/S<br>Holtdam 1<br>3050 Humelbaek, Denmark<br>Establishing Registration: 9610694<br>Owner/Operator: 8010144 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Janell Colley<br>1601 West River Road<br>Minneapolis, MN 55411<br>Office: 612-344-2334<br>Fax: [phone] |
| Date Prepared: | December 17, 2012 |
| Trade Name: | NovaSilk Mesh |
| Common Name: | Surgical Mesh |
| Classification: | II |
| Product Code: | OTO-Mesh, Surgical, Gynecological, for<br>Apical Vaginal Prolapse, Transabdominally Placed |
| Regulation: | 21 CFR 878.3300 |
| Panel: | Obstetrics/Gynecology |
| Predicate Devices: | NovaSilk Mesh, Coloplast (K053414)<br>cleared 12/27/2005<br>Vertessa, Caldera Medical (K120327)<br>cleared 5/10/2012 |

#### Device Description:

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.

#### Intended Use:

NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

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K122968 Page 2 of 2

Image /page/1/Picture/1 description: The image shows the Coloplast logo. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into two parts, with the top part having horizontal lines and the bottom part being a solid color. The word "Coloplast" is written in a bold, sans-serif font.

Ostomy Care Urology & Continence Care Wound & Skin Care

### Predicate Device Comparison:

The technological characteristics of NovaSilk Mesh (subject device) are identical to NovaSilk Mesh (K053414, predicate device). NovaSilk Mesh (subject device) has narrower indications for use than NovaSilk Mesh (K053414, predicate device). The fundamental scientific technology has not changed from the predicate device to the subject device. NovaSilk Mesh (subject device) also has similar materials and indications for use as Vertessa (K120327, predicate device).

#### Performance Data Summary:

Design verification, biocompatibility, sterilization, and shelf life testing completed on the predicate Novasilk Mesh confirm the subject device meets the established design specifications and is substantially equivalent to the predicate:

#### Conclusions:

NovaSilk Mesh is substantially equivalent to the proposed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

December 18, 2012

Coloplast Corp. % Ms. Janell Colley Regulatory Affairs Manager 1601 West River Road North MINNEAPOLIS MN 55411

Re: K122968

Trade/Device Name: NovaSilk Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: September 24, 2012 Received: September 25, 2012

### Dear Ms. Colley:

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.

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## Page 2 – Ms. Janell Colley

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); 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Herbert R. Lerner**

for 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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#### Statement of Indications for Use 5

K122968 510(k) Number (if known): _

Device Name: NovaSilk Mesh

Indications for Use:

NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/ sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment of vaginal vault prolapse is warranted.

Prescription Use __ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

# Herbert R. Lerner

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122968 510(k) Number

> NovaSilk Narrowed Indications Traditional 510(k) 11 of 518