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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. VortexTM Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus. The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube. The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.

The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196℃ requiring either active or passive venting during surgical procedures. The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade and/or low grade dysplasia) 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.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade dysplasia) 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 Kits: Currently, there are 2 types of spray kits available. One kit is available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting Cryo Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use. CryoDecrompression Tube (CDT): Proposed changes involve the CryoDecrompression Tube (CDT) only. The CDT is a necessary part of the truFreeze Active Venting Kit to suction gas out of the patient when liquid nitrogen is sprayed.

Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC, 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 Kits: Currently, there are 2 types of spray kits available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting CryoDecompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use. This 510(k) introduces a third Spray Kit to the truFreeze System, referred to as the Rapid AV Spray Kit. These catheters provided with the proposed truFreeze System are only to be used for active venting procedures and have been modified to shorten the time it takes to pre-cool the catheter so it can achieve frost quicker. The proposed Rapid AV Spray Kit consists of a carton with five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the Rapid AV Spray Kit includes a carton of five (5) sterile, single-use, dual-lumen Cryo- Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions 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 (e.g. Barrett's Esophagus with high grade dysplasia) 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. The console is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised. 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 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. The disposable kit is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised.

Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC 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 stop 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 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 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. There is a proposed change to the active venting disposable spray kit. The proposed change reduces the Outside Diameter (OD) of the CDT from 20 French to 16 French without changing performance specifications, adds additional Marker Bands to the 16 French version of the CDT and makes the 16 Fr CDT and 20 Fr CDT available as a 5-pack box in addition to as a part of the active venting kit.

Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC 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, 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.

The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. 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 treatment 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 wireless remote control provides alternative timer control from a distance in the treatment room. 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 no proposed changes to the 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.

The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. 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

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment 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 wireless remote control provides alternative timer control from a distance in the treatment room. 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 no proposed changes to the disposable spray kit. The truFreeze disposable spray kit continues to consist of five (5) individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the onboard suction system.

The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. 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 treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) 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 wireless remote control provides alternative timer control from a distance in the treatment room. 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: The truFreeze disposable spray kit consists of 5 individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer.) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing.). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.