XSense Cryoablation System with CryoProbes

The XSense Cryoablation System with CryoProbes is a cryosurgical device that destroys tissue using extreme cold temperatures delivered through cryoprobes. It is intended for use in multiple surgical specialties including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology to ablate tumors, fibroadenomas, skin lesions, warts, and other tissue. The system operates with imaging guidance such as ultrasound for real-time visualization.

The subject device is identical to the predicate device (K240892) in all technological characteristics except for the CryoProbes' shelf-life, which was extended from one year to two years. The change was validated according to well-established FDA-recognized consensus standards with no deviations, demonstrating no new safety or efficacy concerns.

The shelf-life validation was conducted according to well-established FDA-recognized consensus standards. The document does not specify the particular ISO, IEC, or ASTM standards by name.

The XSense Cryoablation System with CryoProbes is substantially equivalent to its predicate (K240892) because both devices have the same intended use, indications for use, principles of operation, and technological characteristics. The only difference—an extended shelf-life from one to two years—was validated using FDA-recognized consensus standards with all acceptance criteria met, raising no new safety or efficacy questions.