Co-Ablation System with Sterile Co-Ablation Probe

The Co-Ablation System with Sterile Co-Ablation Probe is a cryosurgical device designed to destroy solid tumors by freezing tissue using liquid nitrogen, followed by active warming to facilitate probe removal. It is intended for use in open, minimally invasive, or endoscopic surgical procedures across multiple specialties including general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery.

The device uses a phase-change effect with liquid nitrogen to achieve freeze temperatures of -186°C ± 10°C and warm temperatures of 75°C ± 10°C using ethyl alcohol. It features 20 probe specifications in straight and right-angled configurations with outer diameters ranging from 1.7 to 3.0 mm, operates in freeze/warm/pause modes with manual and procedural planning controls, and supports 1–4 probe channels and temperature monitoring channels. The system includes a mobile console with cryogenic and warming tanks, control display, and single-use sterile probes made of 304 stainless steel with vacuum insulation and trocar tips.

ISO 10993 (biocompatibility), ISO 11135 and ISO 11737 (sterilization validation), ISO 11607 (packaging), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 and IEC 62366 (usability), IEC 62304 (software development), and ANSI/AAMI ES60601-1.

The subject device shares substantially identical intended use, indications for use, principles of operation (phase-change cryoablation), materials (304 stainless steel), sterilization method (ethyl oxide), and biocompatibility classification with predicate devices CRYOCARE TOUCH System (K201588), XSense Cryoablation System (K240892), and ISOLIS Cryoprobe (K230271). Minor technological differences—such as higher warm temperature (75°C vs. 40°C), different cryogen source (liquid nitrogen vs. argon or nitrogen gas), and varying probe configurations and channel counts—do not introduce new safety or effectiveness concerns because they operate on the same fundamental freezing-thawing mechanism and non-clinical testing (ex-vivo, animal, performance) demonstrates comparable efficacy and safety profiles.