Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

The Alexis Lighted Wound Protector-Retractor is a surgical device that retracts and protects abdominal incisions during laparoscopic and open surgery while providing supplemental illumination via embedded LEDs. It consists of a sterile sheath, outer ring, inner ring with LEDs, a power cord, and a reusable power supply, allowing surgeons to access the abdominal cavity with minimal incision size and maximum exposure.

The subject device uses embedded LEDs powered by a mains-connected reusable power supply for illumination, whereas the secondary predicate uses a filament bulb powered by battery. Both devices share the same wound protection and retraction design with a sheath, outer ring, and inner ring made of identical materials. The subject device was evaluated against IEC 60601-1, IEC 60601-1-2, and IEC 62471 standards for electrical, mechanical, thermal, and photobiological safety.

Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, irritation, acute toxicity, pyrogens); electromagnetic compatibility and immunity per IEC 60601-1-2 and ANSI AAMI standards; electrical, mechanical, and thermal safety per IEC 60601-1 and related editions; optical radiation safety per IEC 62471:2006; functional performance testing including illumination, retraction, anchoring, and viral penetration.