Device Dossier

ProSense Unit - Electronic general cryosurgical system

Device Dossier for ProSense Unit - Electronic general cryosurgical system (General cryosurgical system, cryogen gas, electronic, Class IIb, sponsor…

Intended purpose

The ProSense™ cryoablation system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.An assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is typically used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

TGA Public Summary