VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

K111881 · Coloplast A/S · OTM · Aug 17, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111881
• Device Name: VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
• Applicant: Coloplast A/S
• Product Code: OTM · General, Plastic Surgery
• Decision Date: Aug 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI). The Applied Alexis Wound Retractor is indicated for use to: Access the abdominal cavity during surgery through an atraumatically retracted incision. Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

Device Story

Convenience kit combining Virtue Male Sling System and Alexis Wound Retractor. Virtue system: polypropylene mesh with four arms, sleeves, and sutures; used for suburethral support in male SUI treatment; implanted by physician. Alexis retractor: cylindrical membrane sheath with two plastic rings; provides atraumatic incision retraction, wound protection, and exposure during surgery; smaller sizes allow peritoneal insufflation and conversion of incision to trocar port. Used in OR settings. No electronic components or algorithms.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Virtue: Polypropylene mesh, stainless steel wireform introducer. Alexis: Plastic rings, cylindrical membrane sheath. Non-electronic, mechanical devices. Sterilization: No changes to existing validated methods.

Indications for Use

Indicated for male patients with stress urinary incontinence (SUI) requiring suburethral support, and for surgical patients requiring abdominal or thoracic cavity access, wound retraction, and protection during laparoscopic or open procedures.

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 (K101297)
• Alexis (K041711)

Submission Summary (Full Text)

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K111881/

AUG 1 7 2011

| 510(k) Owner/Submitter | Coloplast A/S; Division: Coloplast Corp<br>Holtedam 1<br>Humlebaek 3050 - Denmark |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Contact | Janell A. Colley<br>Coloplast Corp<br>1601 West River Road North<br>Minneapolis, Minnesota 55411 USA |
| Date Prepared | 30 June 2011 |
| Common name/<br>Classification | Virtue: Surgical Mesh: 21CFR 878.3300;<br>Alexis: Surgical drape and drape accessories: 878.4370 |
| Proprietary Name | Virtue Male Sling System with Alexis Wound Retractor |
| Predicate Devices | Virtue: K101297;<br>Alexis: K041711 |
| Device Descriptions | |
| The Coloplast Virtue Male 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. The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large. The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box. | |
| Intended Use | |
| The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI). | |
| The Applied Alexis Wound Retractor is indicated for use to: | |
| Access the abdominal cavity during surgery through an atraumatically retracted incision. Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision. | |
| Technological Characteristics Compared to Predicate | |
| The Virtue Male Sling System with Alexis Wound Retractor has the same intended use, design, materials and fundamental scientific technology as the predicates Virtue System K101297 and Alexis K041711. | |
| Summary Of The Nonclinical Tests Submitted | |
| The Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k). There are no changes to the sterilization method, SAL, or sterilization parameters for the Virtue System or Alexis Wound Retractor and neither device will be subjected to additional sterilization cycles as a result of being offered for sale in the same package. Thus, additional sterilization validation is not necessary to support this Special 510(k). Evaluation of the packaging configuration for the Virtue Male Sling System with Alexis Wound Retractor demonstrates that the convenience kit packaging is substantially equivalent to the predicate devices' packaging; therefore, no additional design verification or validation testing was conducted. | |
| Summary Of Clinical Tests Submitted (As Applicable) | |
| Not applicable | |
| Conclusions Drawn From The Nonclinical Tests | |
| The Virtue Male Sling System with Alexis Wound Retractor is substantially equivalent to the predicates. | |

## 3 510(k) Summary

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Confidential

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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 or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Ms. Janell A. Colley Regulatory Affairs Manager Coloplast A/S Coloplast Corporation 1601 West River Road North MINNEAPOLIS MN 55411

OCT 12 2012

K11881 Re:

> Trade/Device Name: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM, GAD, KKX Dated: June 30, 2011 Received: July 1, 2011

Dear Ms. Colley:

This letter corrects our substantially equivalent letter of August 17, 2011.

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/CDRH0ffices/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. 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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## 2 Statement of Indications for Use

## Indications for Use

510(k) Number (if known):

Device Name: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit

The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

- Access the abdominal cavity during surgery through an atraumatically . retracted incision.
- Deliver maximum exposure of the abdominal cavity with minimum incision.
- . Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

- . Scal off the incision opening to permit insufflating the peritoneum.
- Convert the incision wound to an additional trocar port site. ●
- Access the thoracic cavity or other soft tissue retraction during cardiac and . general surgical procedures through an atraumatically-retracted incision.

Prescription Use **X**

(Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 801 Subpart C)

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Over-The-Counter Use

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

A. A. Turner

Concurrence of CDRH, Office of Device Evaluation (ODE) - Sign-

of Reproductive. Gastro-Renal, and 0(k) Niimhe

Confidential