cryoICE cryoXT cryoablation probe (cryoXT)

The cryoICE cryoXT is a sterile, single-use cryoablation probe designed to temporarily block pain by freezing peripheral nerves, causing cryonecrosis (tissue death through inflammatory response). It is approximately 11 inches long with a blunt prong-shaped distal tip and operates by circulating nitrous oxide through the device via a hand-held handle connected to an AtriCure cryoICE BOX console.

The cryoXT uses the Joule-Thompson effect with nitrous oxide to reach operating temperatures below -40°C, identical to predicate devices. The key difference is the distal tip design: the proposed cryoXT features a linear prong-shaped probe with cylindrical arms (aluminum), compared to the predicate's linear cylindrical probe and reference device's ball-shaped probe. All other characteristics—shaft length (28 cm), biocompatible materials, sterile single-use packaging, gamma irradiation sterilization, and hand-held console operation—are equivalent.

Not stated in this summary. The document lists bench testing performed (cryogenic performance, iceball performance, mechanical reliability, pressure cycle withstand, drop test, dimensional verification, biocompatibility, and sterility) but does not reference specific consensus standards such as ISO, IEC, or ASTM numbers.

AtriCure argues substantial equivalence based on identical intended use (temporarily blocking pain via peripheral nerve ablation through freezing), same operating principle (Joule-Thompson effect), same energy source (nitrous oxide), and identical specifications for temperature, shaft length, materials, and sterilization. The prong-shaped distal tip design change is supported by bench testing demonstrating equivalent cryogenic and iceball performance with no new safety issues, positioning it as a design refinement based on physician feedback rather than a fundamental alteration to device function or risk profile.