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The Precision™ Plus TUNA® Office System is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The Precision™ Plus TUNA® Office System consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories. The Precision™ Plus TUNA® Office System delivers low levels of 460 kHz RF energy up to 15 W from each of the 2 needles directly into prostatic tissue to produce a localized necrotic lesion to treat the symptoms associate with BPH. Each lesion takes 3.0 minutes.

The TUNA® System Product Family, including Precision™ TUNA® Office System and PROVu™ TUNA® System, is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Each System of the TUNA System Product Family consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories.

The TUNA Office System is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Precision™ TUNA® Office System with Model 6800 Cartridge, Model 6198 Handle, Model 7800 RF Generator (with no rectal temperature monitoring tape)

The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The Cobra Hand Piece delivers the energy from the VidaMed TUNA System RF Generator. The Cobra Hand Piece contains two needle electrodes which are deployed at an angle of 90°. The needles can be deployed at 4 preset lengths which vary between 10-22mm. The needles are insulated at the base to protect the urethra during ablation of the prostatic tissue. The disposable Cobra Cartridge is attached to a reusable handle, containing the mechanism for the needle deployment and retraction. The Cobra Hand Piece only works with the VidaMed TUNA System RF Generator.

The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The VIDAMED TUNA System includes an RF generator and an accessory catheter for delivery of energy to the patient. The TUNA 5 Catheter contains two electrodes which can be deployed through a cystoscopic sheath at various angles between 0° and various lengths between 14 and 22 mm. The needles are insulated at the base to protect the urethra during ablation of tissue.

The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.

The VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.

The VIDAMED RF Generator Data Recorder is designed for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. When used with VIDAMED RF Generators, the VIDAMED RF Generator Data Recorder Software is capable of recording the lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.

The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics. The electrosurgical generator is capable of delivering up to 30W (15W / channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue.