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The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.

The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues. The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items: - Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator - Canady Helios™ Cold Plasma Ablators - Foot Pedal - Trolley Cart The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.

The Canady Flex RoboWrist is intended for grasping, mobilization, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

The Canady Flex RoboWrist is a motorized, hand-held laparoscopic surgery instrument available with hook, scissors, or needle holder end-effectors. The device includes a connector for an electrosurgical generator, which allows the option of using the mono scissors or hook for electrosurgery. The Canady Flex RoboWrist primarily intended for dissection, and/or suturing of tissue under direct and endoscopic visualization in minimally invasive surgical procedures for interventions such as laparoscopic (urologic, gynecologic) or thoracic surgeries. The Canady Flex RoboWrist is composed of an instrument (with end-effectors) and a control unit, which provides power to the instrument. Three models of instruments are available: needle-holder, monopolar hook and monopolar scissors. An electrical cable is provided to connect the instrument to the control unit. It is also provided with a sterilization tray.

The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces. The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.

The Canady Plasma® SMART XL-1000™ Electrosurgical Generator (CPSXEG) with Accessories is a High Frequency (HF) Electrosurgery Unit (ESU) used in combination with electrosurgical probes. The CPSXEG combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. The CPSXEG is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting, coagulation, hybrid plasma, and argon plasma modes to meet the physician's flexibility performing the specific procedure with the device. The modified Canady Plasma Smart XL-1000™ ESU has the same intended use as the predicate SS-601/Argon 4 Canady Plasma® Electrosurgical Unit as well as the same performance specifications. The modified device has the same protective circuits as the predicate ESU which displays the equipment output error on the monitor screen with a graphic symbol so that the user can determine the cause of the error. The packaging, labeling (i.e. user manual) are the same. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator has a touch screen color monitor that provides the user with quick start, on screen tutorial and user manual as well as operational and settings. Various cutting, coagulation, bipolar, and plasma modes are the predicate unit, but the modified device has improved programmable software. When turned on, an APPS screen is displayed on the monitor screen. The user can decide which medical application is started by touching the particular application (i.e Pediatrics, orthopedics, endoscopy, gynecology). Upon activation of the device audio and visual error system malfunctions or user errors can be observed by the user. Once the device is activated, power in watts, gas flow rate, gas volume, PPM, and energy mode are displayed on the monitor screen.