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AtriCure's cryoICE® cryoXT™ cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

The cryoICE® cryoXT™ probe is a sterile, single-use device designed to enable cryoablation of target nerves by allowing surgeons to surround exposed peripheral nerves with its blunt prong-shaped distal tip, and in conjunction with an AtriCure cryoICE BOX (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. cryoXT is offered in one single probe length of approximately 11" (28 cm) long. The device has a flexible tubeset that consists of a gas supply tube and exhaust tube, a handle, a malleable probe which is covered by an insulating sheath and has a prong-shaped distal tip at the distal end.

The iovera® System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera System is not indicated for treatment of central nervous system tissue. When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

The iovera System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of four main components: - A reusable Handpiece . - A Charging Dock ● - An assortment of single-patient-use Smart Tips ● - A Cartridge containing nitrous oxide ●

The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F). In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle. The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

FOR ADULT PATIENTS AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis). FOR ADOLESCENT PATIENTS The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age. *Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are sterile, single use devices that achieve cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX device is offered in two probe length configurations: approximately 11" and 17" long. At the distal end, the ryoICE cryoSPHERE+ and cryoICE cryoSPHERE MAX probe features an 8mm or 10mm diameter ball tip shape for each length configuration. The flexible region of the probe is malleable and is capable of being bent by the end user using an included forming tool.

The iovera System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" System is not indicated for treatment of central nervous system tissue. When stimulation compatible components are used , the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

The iovera? System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device comprises four main components: - A reusable Handpiece - A Charging Dock - An assortment of single-patient-use Smart Tips - A Cartridge containing nitrous oxide The iovera® System Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece contains an LCD display for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery. An assortment of Smart Tips is available for the ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera® System. The user removes the Smart Tip from its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment. The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.

The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The ioveraº system is not indicated for treatment of central nervous system tissue.

The iovera° system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N₂O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The device comprises four main components: A reusable Handpiece, A Charging Dock, An assortment of single-patient-use Smart Tips, A Cartridge containing nitrous oxide.

For Adult Patients AtriCure's Cryo2 cryo2 cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. For Adolescent Patients The Cryo2 cryolCE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age. 1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology. For Adult Patients AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves. For Adolescent Patients The cryolCE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age. 1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac surgery; it is also intended for use in blocking pain by temporarily ablatinq peripheral nerves. The cryosurgical handpiece uilizes a high-pressure cryogen (nitrous oxide, N20) to freeze target tissues, creating an inflammatory response, and ultimately, cryonerosis. The cryosurgical handpiece provides below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitous oxide is supplied to the cryprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryolip, of the probe is malleable to allow access to varying anatomy and anatomical sites. The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three infices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be cryotip into the desired form. The cryolip is attached to an insulated rigid shaft that allows the surgeon to adjust the exposed cryolip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM). The cryoICE PROBE is a sterile, single-use cryosurgical instrument. The form tool facilitates bending of the malleable tip. This PROBE was designed for treatment of cardieving controlled temperatures down to -50° to -70°C; it can also be used to temporarily block pain by ablating peripheral nerves in adolescent patients of at least 12 years of aqe. The cryolCE cryoSPHERE cryoablation (CRYOS/CRYOS-L) probe is a single use cryablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe. The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the supplied TOOL. The PROBE features a spherical 8mm cryoablation tip.

AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryolCE cryoSPHERE cryoablation (CRYOS) probe is a single use device that achieves cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable, and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.

The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue. The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

The iovera system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® system may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of four main components: 1. A reusable Handpiece 2. A Charging Dock 3. An assortment of single-patient use Smart Tips 4. A Cartridge (Nitrous Oxide)

AtriCure's cryolCE cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery; it is also intended for use in blocking pain by temporarily ablating peripheral nerves. The cryosurgical handpiece utilizes a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpiece provides probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probe is malleable to allow access to varying and anatomical sites. The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used to bend the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).