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The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Switch Pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode. New Deantronics is requesting clearance two series Smoke Evacuation Pencils. The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.) The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series. The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system. These devices are single use and are sold sterile.

The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight. The Electrosurgical Generator supplies high frequency electrosurgical power from low power (<30W), medium power (Cut: 30~100W, Coag: 30~70W), to high power (Cut >100W, Coag>70W). The Electrosurgical Generator outputs high frequency energy in the following modes: 1. Monopolar CUT: Pure Blend 1 Blend 2 2. Monopolar COAG: Pin Point Spray 3. Bipolar: Standard The Electrosurgical Generator can be activated via a hand switch or a foot switch. The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode. The Electrosurgical Generator is mains powered.

A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.

The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current. The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode. During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only.

The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue.

The Argon Handset is intended to be used in electrosurgical procedures where monopolar standard or argon enhanced electrosurgery is desired. The pre-installed blade electrode is used in open surgery, while the longer argon electrodes can replace the blade electrode to be used in minimally invasive procedure. The Argon Handset has to be in conjunction with an electrosurgical generator, argon gas delivery system and patient return electrode. During the operation, the argon handset performs like a standard electrosurgical pencil, while it receives both the argon gas and high frequency current, and delivers the electrosurgical energy onto a target tissue for either a standard or argon-enhanced procedure. The Argon Handset is sold in sterile packaging and is a single use device. These devices can be used in hospitals and are used by trained professionals only. The Argon Handset is designed for fitting into the Covidien Argon Gas Delivery Unit II or Force™ GSU Argon Gas Delivery Systems, and Covidien Force EZ™ or Force FX™ series electrosurgical generators. The blade electrode of the Argon Handset is replaceable by the New Deantronics Argon Electrode Series or Covidien E35XX series Argon Electrodes depending on the surgical procedures required.

The Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired. The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired. The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.

The New Deantronics Argon Electrode is designed to connect to a third-party argon handset. The electrosurgical energy is conducted from the argon handset, through the electrode to the electrosurgical target site, as is the argon gas flow. When the device is activated, the argon gas will be transformed into a plasma state flowing out of the electrode. By directly or indirectly contacting the energized electrode with the target tissue, the New Deantronics Argon Electrode can facilitate argon-enhanced coagulation, as well as standard electrosurgical cut and coagulation, as indicated.

These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.

The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.

The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.

The Irrigation Tubing Bipolar Cord Se is designed to connect to both an electrical generator and bipolar forceps via an electrically conducting cord and to a saline source for irrigation via a catheter to provide simultaneous coagulation capabilities and irrigation capabilities. A co-extrusion manufacturing process is applied to integrate a bipolar cord with irrigation tubing into one unit. This integrated Irrigation Tubing Bipolar Cord set are helpful to keep the bipolar electrosurgery organized. The electrically conducting cord is formed with a pair of copper wires each coaxially surrounded by an outer insulation sheath. The insulated bipolar cord (24 AWG) provides safety protection to patients and surgical staff. The fluid catheter is formed of PVC and silicone tubing connected by connectors and is defined as fluid passage pathway.