ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

The ERBECRYO 2 is a cryosurgical unit that delivers regulated CO₂ gas to flexible cryoprobes to destroy tissue through extreme cold (Joule-Thomson effect). The new Erbe Flexible Cryoprobes are sterile, single-use probes intended for palliative devitalization and removal of foreign bodies, blood clots, tumors, and tissue biopsies during interventional procedures, particularly in the gastrointestinal tract.

The subject device adds an elongated variant of the flexible cryoprobe with increased distal length (2550 mm vs. 1150 mm in predicate), outer diameter of 1.7 mm, and same input pressure range (769–943 psi). All other characteristics—materials (stainless steel, silicone, plastics), operating principle (CO₂ cooling), energy delivery, sterilization method (ethylene oxide), and shelf-life (3 years)—are identical to the predicate device.

ISO 13485 (design controls), ISO 14971 (risk analysis), ISO 11135 (sterilization validation), ISO 10993-1 and ISO 10993-7 (biocompatibility and EO residuals), ISO 11607-1 (packaging), ASTM F 1980 (shelf-life aging), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1 (electrical safety), and IEC 62304 (software verification).

The subject device is substantially equivalent because it has identical intended use, the same fundamental design and energy source, and equivalent freezing performance as demonstrated by side-by-side tissue testing. The only difference—increased probe length—poses no new safety or effectiveness questions and actually provides improved benefits (better reach in the GI tract) while maintaining the same risk profile, supported by peer-reviewed literature and a randomized controlled trial.