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The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa System includes the following system components: Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator. The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.