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Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196 C requiring either active or passive venting during surgical procedures. Indications for Use: The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit. Console: The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction. Disposable spray kit: There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.