Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)

The Alexis Lighted Wound Protector-Retractor is a surgical device that retracts and protects surgical wounds while providing supplemental illumination during open and laparoscopic surgery. Available in extra small, small, medium, and large sizes with flexible or rigid outer rings, it allows surgeons to access the abdominal cavity with minimal incision size and can maintain pneumoperitoneum or serve as a trocar port in smaller variants.

The subject device expands the predicate's offering from medium size only to four sizes (extra small, small, medium, large). All subject sizes except extra small are available in both rigid and flexible outer ring configurations. Extra small and small variants include a tether and tether tag for removal assistance; biocompatibility of these components was validated per ISO 10993-1 standards.

IEC 60601-1 and variants (electrical/safety), IEC/CISPR 11 (emissions), IEC 61000 series (EMC and immunity), ISO 10993 series (biocompatibility), IEC 62471:2006 (optical radiation safety), and functional performance testing covering illumination, retraction, anchoring, insufflation, insertion/removal cycling, and viral penetration.

The subject device is substantially equivalent to predicate K253531 because it uses identical materials and processing, maintains the same intended use and principles of operation for wound retraction and illumination, and demonstrates equivalent safety and performance through comprehensive non-clinical testing. Size and configuration variations do not introduce new indications or risks, and differences in indications across sizes reflect clinical needs rather than fundamental design changes.