Focused Cryotherapy System

The Focused Cryotherapy System is a cryoablation platform comprising a handheld probe, console, and software that uses high-pressure argon gas to freeze and destroy tissue through extreme cold temperatures. It is indicated for cryoablative destruction of tissue across multiple surgical specialties including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for ablation of tumors, nerves, prostate tissue, skin lesions, and other targets.

The subject device includes an electrical heating element for directional ablation (versus helium thaw in predicate), operates at 3500 psi (same as secondary predicate), supports 4 simultaneous probes versus 8 in predicates, features both circumferential and directional freeze modes, uses a 2.1 mm diameter probe with 20 cm length, and incorporates software-enabled temperature feedback with internal thermocouple.

Testing was conducted per IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 62304 (software development), IEC 62366 (human factors), ISO 10993 series (biocompatibility), and ISO 11135 (sterilization validation).

Although the subject device differs in heating mechanism, directional ablation capability, number of active channels, and probe length compared to predicates, performance testing including ex-vivo tissue studies and isotherm comparative testing demonstrated substantially equivalent thermal performance and safety profile. The device has identical intended use as predicates and all performance tests met acceptance criteria, with no new safety or effectiveness risks identified.