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The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

The Non-Telescopic PenEvac is defined as monopolar electrosurgical pencil with smoke evacuation capabilities. The device is designed for general electrosurgical applications including cutting and coagulating and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Non-Telescopic PenEvac is intended to be used by trained professionals and will be marketed as a single use device, having different configuration as far as: type of electrode, length of tubing and end connector. The proposed device is the same as the predicate Telescoping PenEvac. The only modification is a change in the telescopic tip, as the Non-Telescopic PenEvac does not have the telescope capability.

The I.C. Medical SI Controller Model SI 500 is intended to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories having compatible suction/irrigation features during wound care and closed surgical procedures. When used with appropriate accessories the SI Controller may be used for hydro-dissection. The SI Controller is not intended for use in delivering any blood or blood products

The SI Controller Model SI500 controls the flow of fluids and vacuum to suction/irrigation and multifunction accessories used during -wound-eare and-open and closed surgical procedures and may be used for hydrodissection. Also included in this 510(k) application are tubing sets, disposable fluid canisters and accessories used to connect other surgical accessories to the irrigation fluid and vacuum sources. An electrical cable is also provided to accommodate remote sensing from I.C. Medical Crystal Vision smoke evacuators (K932230) in order to automatically activate and deactivate the SI Controller. I.C. Medical recommends that this device be used with the PenEvac SI (K95166) which is a multifunction suction, irrigation, ESU monopolar electrode device.

The Telescoping PenEvac is intended to be used as the active monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during the procedure.

The Telessoping PenEvac is a combination of an electrosurgery switching handpiece and a smoke evacuation shroud with a telescoping tip that allows the surgeon to adjust the tip length. It includes pushbutton switches to allow the surgeon to select "cut" or "coagulation" operating modes on typical electrosurgery generators. The device will be marketed in two versions: As a complete single use sterile product. As a partially reusable product with the PenEvac body and electrosurgery cord being reusable and the remainder of the device as a sterile single use product. Electrodes of various lengths and shapes will be available.

The PenEvac SI is a multifunction handpiece that is meant to provide the following optional functions: monopolar electrode handpiece in an electrosurgery generator system, suction, and to facilitate the removal of smoke generated during the procedure. The intended use is the same as the predicate devices.

The PenEvac SI is a multifunction device that optionally features suction, irrigation, electrosurgery "cut" or "coag, " and smoke evacuator functions. The device is intended to be used with an I.C. Medical Suction/Irrigator/Smoke Evacuator and common electrosurgery generators. The PenEvac SI has a handpiece body that accepts various tips and endpieces to furnish different operating functions. The handpiece body will be available as either a sterile single use device or as a reusable device. The handpiece features two pushbutton switches and an electrosurgery cord and connector. The handpiece bodies are identical to the predicate Telescoping PenEvac bodies. Changing the tip will change the function of the handpiece. There are three different configurations available: SIE (Suction, Irrigation, monopolar Electrode) Configuration, SI (Suction, Irrigation) 2 Channel, and SI (Suction, Irrigation) 1 Channel.

The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.

The Telescoping PenEvac ABC is a combination of an argon beam coagulator pencil and an electrosurgery switching handpiece with a smoke evacuation shroud. It is intended to be used with argon beam generators that include electrosurgery capabilities. The device has push button switches to allow the surgeon to select CUT, COAG, or ARGON functions on the generator. An ARGON ASSIST mode can be selected by sliding the tip of the ABC Telescoping Tip back to expose the monopolar electrode. The device consists of three major components: PenEvac Body, ABC Adapter, and ABC Telescoping Tip. The PenEvac Body contains the pushbutton switches and ESU cord and connector. The ABC Adapter fits into the rear of the PenEvac Body and contains flexible tubing, generator connector, electrical conductor, and a rigid metal tube that fits into the PenEvac Body. The ABC Telescoping Tip is used during open surgical procedures. The tip may be extended or shortened as desired. It also has a sliding tip that can expose, or conceal, the electrode during argon procedures.