CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

The CoolCryo is a cardiac cryoablation system consisting of a single-use sterile cryoapplicator probe and a reusable control console with a liquid nitrogen reservoir. It is indicated for cryosurgical treatment of cardiac arrhythmias by freezing target heart tissues to create lesions that block electrical conduction pathways. The device is intended for use by trained healthcare professionals in hospital operating rooms on adult patients.

The CoolCryo uses liquid nitrogen delivered via direct flow to freeze tissue, compared to the predicate's nitrous oxide gas via Joule-Thompson effect. The probe is made of aluminum alloy (5.7 mm diameter) versus the predicate's stainless steel (3.9 mm). The console is larger (115 cm height) than the predicate (11.4 cm height) and includes a touch screen plus additional display on the applicator. Both devices have similar operating modes (standby/freeze/defrost), active defrost, automatic treatment timing, and monitor comparable parameters including temperature, pressure, and cryogen levels.

ISO 10993-1 for biocompatibility testing; IEC 60601-1 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility; FDA guidance on device software documentation (Enhanced level); and FDA guidance on non-clinical bench performance testing. Sterilization validation and shelf-life testing were also performed.