KnoxFog Anti-fogging Device

KnoxFog is a semi-gel anti-fog coating applied to rigid endoscope lenses immediately before endoscopic procedures to prevent condensation and maintain optical clarity during surgery. It forms a transparent hydrophilic film on the lens surface that prevents fogging in high-humidity surgical environments and is terminally sterilized using gamma radiation.

KnoxFog utilizes a semi-sol gel formulation that transforms into a solid-phase film when applied to the endoscope lens, creating a hydrophilic surface that prevents water condensation when the lens encounters temperature differentials and humid environments typical of endoscopic procedures.

ISO 10993 standards for biocompatibility testing were applied to demonstrate that KnoxFog is biocompatible for its intended use.

KnoxFog demonstrates superior or equivalent performance to the predicate device VitreOx (K163257) through comparative bench testing showing 71.6 ± 3 minutes fog-free performance versus VitreOx's 62 ± 5.5 minutes (117% relative performance). Transportation, accelerated aging, and biocompatibility testing confirm the product performs as intended without raising new safety or effectiveness questions, establishing substantial equivalence based on similar intended use and technological function despite improved performance metrics.