iovera° System

The iovera° System is a portable cryogenic surgical device that destroys tissue and produces lesions in peripheral nervous tissue by applying extreme cold (nitrous oxide) through a needle-like Smart Tip. It is indicated for tissue destruction during surgery, pain relief from peripheral nerve lesions, and relief of knee osteoarthritis pain for up to 90 days. When used with compatible nerve stimulation components, it can also facilitate nerve location detection.

The subject device introduces a new 25-gauge, 180 mm long Smart Tip (STT21180STIM) with nerve stimulation capability. Key differences from predicates: the needle is longer to reach deeper peripheral nerves, has a blunt tip (used with an off-the-shelf introducer that provides the sharp entry point), includes no parylene coating, and has extended cooling time (70 seconds) and shorter post-heat time (15 seconds). The handpiece, cartridge system, operating principle, temperature range, and all other subsystems remain identical to predicate devices.

Testing conformed to IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability engineering), IEC 62304 (software lifecycle), ISO 10993-1 (biocompatibility), ASTM F1980 and ISO 11135:2014 (sterilization), ASTM D4332 (packaging), ISO 11607 (sterile barrier systems), and EN ISO 10993-7 (ethylene oxide residuals).

The subject device shares the same intended use, indications, design, materials, and operating principles as predicates K220656 and K211334—all use nitrous oxide cryotherapy to create lesions in peripheral nerves via closed-end needles. The new STT21180STIM is a topological variant (longer needle, different gauge) designed for deeper nerve access using standard introducers; the needle itself remains uncoated stainless steel with closed-end design, same cryogenic mechanism, and same therapeutic outcome. All nonclinical testing (biocompatibility, electrical safety, software, mechanical strength, sterility) demonstrates equivalent safety and performance. The longer needle and adjusted cycle times do not create new safety or effectiveness concerns because the clinical mechanism—cellular death through cryoneurolysis—is unchanged, and mechanical testing confirmed reliability with the introducer.