VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM

K082640 · Coloplast Manufacturing Us, LLC · OTM · Oct 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082640
• Device Name: VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
• Applicant: Coloplast Manufacturing Us, LLC
• Product Code: OTM · General, Plastic Surgery
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• 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

The VIRTUE Ventral Urethral Elevation Sling System is a surgical implant designed to treat male stress urinary incontinence. The device consists of a polypropylene mesh with four arms, each covered by a sleeve with an attached suture for connection to an introducer. The introducer features a handle and a stainless steel wireform. The system is provided sterile for single-use. It is intended for surgical implantation by a physician to provide suburethral support, thereby assisting in the management of incontinence.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and biocompatibility testing.

Technological Characteristics

Polypropylene mesh; stainless steel wireform introducer; single-use; sterile; non-active implantable device.

Indications for Use

Indicated for the treatment of male stress urinary incontinence (SUI) in adult males.

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

• American Medical Systems (AMS) AdVance Male Sling System (K053371)

Submission Summary (Full Text)

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K08 2640
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#### 5 510(k) Summary

| 510(K) Owner's Name: | Coloplast A/S | OCT 17 2008 |
|-------------------------|---------------------------------------------------------------------------------------------------------|-------------|
| Address: | Holtedam 1<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: | September 9, 2008 | |
| 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 Coloplast VIRTUE Ventral Urethral Elevation Sling System is substantially equivalent in performance, indications, design and materials to American Medical Systems (AMS) AdVance Male Sling System cleared under premarket notification number K053371.

# Description Of The Device:

The 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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K082640
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#### Intended Use Of The Device:

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

# Technological Characteristics Compared To Predicate Device:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is substantially equivalent in design, materials, performance characteristics, and indications to the predicate American Medical Systems (AMS) AdVance Male Sling System cleared under premarket notification number K053371.

# Summary and Conclusions of The Nonclinical Tests Submitted:

Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2008

Coloplast Corporation % Ms. Angela Byland Manager, Regulatory Affairs 1499 West River Road North Minneapolis, Minnesota 55411

Re: K082640

Trade/Device Name: VIRTUE Ventral Urethral Elevation Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 13, 2008 Received: October 14, 2008

Dear Ms. Byland:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Angela Byland

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milken

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

Enclosure

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#### Indications for Use Statement 4

Indications for Use

K082640 510(k) Number (if known): Device Name: VIRTU E Ventral 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 Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Yurke Dyle for man

and Neu cal Device

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(Posted November 13, 200