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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.

The Virtue Male Sling is an implantable, suburethral support sling intended for the surgical treatment of male stress urinary incontinence (SUI). The four-arm design of the Virtue Male Sling provides a dual mechanism of action by providing both compression of the bulbous urethra and proximal urethral elevation. The Virtue Male Sling is constructed of non-absorbable medical grade knitted, monofilament polypropylene and is intended to be permanently implanted.

The Virtue Introducer is used to facilitate transobturator and pre-pubic passages during the surgical placement of the Virtue Male Sling. The introducer is manufactured from polycarbonate thermoplastic elastomer (handle) and medical grade stainless steel (needle). The Virtue Introducer is only to be used with the Virtue Male Sling System in accordance with the Instructions for Use.

The Virtue Male Sling System with Alexis Wound Retractor includes one (1) Virtue Male Sling, one (1) single-use Virtue Introducer and one (1) Alexis Wound Retractor intended to facilitate the placement of the Virtue Male Sling.

The provided FDA 510(k) summary (K231891) for the Virtue Male Sling System with Alexis Wound Retractor indicates that performance data was not necessary for the substantial equivalence determination.

Therefore, the document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The conclusion is based on the subject device having:

• Identical intended use
• Identical target population
• Identical sterilization technique
• Identical biocompatibility features
• Identical overall device design features
• Identical duration of use

compared to its predicate device (K113496, also the Virtue Male Sling System with Alexis Wound Retractor). The submission focused solely on revised labeling, which included:

• Adding a contraindication to align with other Coloplast mesh Instructions for Use (IFU) manuals.
• Updating adverse events based on post-market surveillance and literature analysis.
• Updating procedure details aligned with current literature.

The FDA determined that these labeling changes "do not raise questions of safety or effectiveness."

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