Electro Lube NXT

Electro Lube NXT is a single-use sterile coating applied to electrosurgical instruments during open and minimally-invasive surgery, including robotic-assisted procedures, to reduce tissue sticking and eschar (burned tissue) buildup on the electrode surfaces. It consists of a 4mL vial of Lexolube® CQ-3000 lubricant and a foam applicator pad with adhesive backing and barium strip for visibility.

The device is identical to its predicate device K241055 in composition (same Lexolube® CQ-3000 formulation), components (4mL vial, foam applicator pad, barium cord, medium-density polyethylene bottle), sterilization method (irradiation to 10⁻⁶ SAL), and performance characteristics. The proposed device includes expanded indications to explicitly cover robotic-assisted electrosurgical instruments and adds performance testing for robotic instrument cleaning and thermal spread evaluation on robotic systems.

ASTM Hemolysis Direct Contact and Extract Methods for hemocompatibility; Guinea Pig Maximization Test for skin sensitization; closed-cup flash point determination method (>200°C); MEM Elution for cytotoxicity; Material Mediated Pyrogenicity Test in rabbits; and intracutaneous reactivity testing in rabbits.

The proposed device is substantially equivalent because it maintains identical composition, materials, construction, and manufacturing specifications as the predicate K241055 while demonstrating equivalent or superior performance across all nonclinical tests (tissue adhesion reduction, eschar removal, viscosity, cutting force, ease of removal, thermal spread, and biocompatibility). The expanded claims for robotic-assisted instruments are supported by additional testing showing no negative impact on robotic instrument cleaning or thermal spread, which are extensions of the same fundamental performance characteristics already proven equivalent in the predicate.