VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

K091152 · Coloplast A/S · OTM · May 7, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091152
• Device Name: VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
• Applicant: Coloplast A/S
• Product Code: OTM · General, Plastic Surgery
• Decision Date: May 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Device Story

VIRTUE Ventral Urethral Elevation Sling System is an implantable suburethral support device for male stress urinary incontinence. Device consists of polypropylene mesh with four arms, each covered by a sleeve with attached sutures for introducer connection. Introducer comprises handle and stainless steel wireform. Provided sterile for single use. Used by surgeons in clinical settings to provide urethral support. Device functions as mechanical support to address incontinence; benefits patient by restoring urinary control.

Technological Characteristics

Polypropylene mesh; stainless steel wireform introducer; sterile, single-use kit. Mechanical support device; no software or electronic components.

Indications for Use

Indicated for treatment of male stress urinary incontinence (SUI).

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

• VIRTUE Ventral Urethral Elevation Sling System (K082640)

Submission Summary (Full Text)

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2009 -

## 510(k) Summary

| 510(K) Owner's Name: | Coloplast A/S | MAY - 7 |
|-------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Address: | Holtedam I<br>3050 Humlebaek, Denmark<br>Establishment Registration: 9610694<br>Owner/Operator: 8010144 | |
| Name of Contact Person: | Angela Byland<br>Regulatory Affairs Manager | |
| Phone and Fax Numbers: | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Submission Date: | April 17, 2009 | |
| Trade Name: | VIRTUE™ Ventral Urethral Elevation Sling System | |
| Common or Usual Name: | Sub-Urethral Sling System; Surgical Mesh | |
| Classification Name: | Surgical Mesh, polymeric . | |

## Legally Marketed Device to Which Your Firm is Claiming Equivalence:

· The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System is substantially equivalent in performance, indications, design and materials to the currently marketed VIRTUE Ventral Urethral Elevation Sling System, which was cleared under 510(k) K082640.

## Description of the Device:

The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve . and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

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Image /page/1/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 eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

Coloplast Corporation % Ms. Angela Byland Manager, Regulatory Affairs 1601 West River Road North MINNEAPOLIS MN 55411

OCT 12 2012

Re: K091152 Trade/Device Name: VIRTUE Ventral Urethral Elevation Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM Dated: April 17, 2009 Received: April 20, 2009

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of May 7, 2009.

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 (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" (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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Perkins

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

4041152

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VIRTUE Ventral Urethral Elevation Sling System Indications for Use:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM

(Division Sign-Off) Division of Surgical, Orthopedic,

. Page

(Posted November 13, 300 gestorative Devices

.510(k) Number K091152