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The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The ForceTriad™ is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The generator is intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired. The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed. including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. This 510(k) only applies to the LigaSure™ Vessel sealing portion of the generator. The generator is electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power. The generator is used with a selection of instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete. No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.