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Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures. AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

AEM Single-Use Suction Irrigation Instruments are • Electrosurgical accessories, which combine – Classic active electrode functions of cutting and coagulating tissue with monopolar high-frequency electrical energy – Shape, size and reach to work laparoscopically or endoscopically – Elimination of stray-energy emission outside surgeon view provided by AEM shielding and monitoring – Convenience/peace-of-mind provided by product provided clean and sterile from manufacturer to operating room – Convenience of providing suction or irrigation to the surgical site without having to swap instruments in and out of the cannula • Used to ablate, remove, resect, and coagulate soft tissue where associated hemostasis and visualization is required • For use in open, endoscopic, and laparoscopic surgical procedures The instruments of this submission are configured to support foot-controlled laparoscopic electrosurgery • Direct connection from instrument tip to electrosurgical unit foot-switched power outlet via AEM Cord and Monitor • Suction irrigation channel adapted directly to commercially available suction-irrigation valves • Working length: 32 cm • Fits within 5.5 mm diameter cannula

The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The EM3 AEM Monitor performs two distinct functions: - Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument. - End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.

The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery. - For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view - In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation The EM3 AEM Monitor system comprises two components - The Monitor or electronic unit. - A specific or standard ESU Adapter. An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.

Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures. AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) are electrosurgical accessories that - . Conduct high-frequency monopolar electrosurgical energy from compatible electrosurgical generators (ESU) - . Provide suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. They combine the classic active electrode functions of cutting and coagulation by monopolar energy with the convenience of being able to provide suction and irrigation without having to swap instruments in and out of trocar, port, or cannula. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.

The Encision AEM Monitoring System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The AEM Monitoring System consists of two distinct functions: - . Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument. - End point monitoring is intended to aid the surgeon in determining the end point . of bipolar electrosurgical desiccation.

The Encision AEM Monitoring System, consisting of the AEM Monitor and accessories, is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. The AEM Monitoring System consists of two distinct functions: - 1. End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation. The end point monitor displays the electrosurgical current being delivered during bipolar coagulation. At the point where the tissue or vessel is no longer conductive, the meter will display zero or near zero current. An audible indicator of current, presented as a variable click rate, can also be turned on. An optional remote display is also available. There is no change to the end point monitoring function. - 2. Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument. The active electrode monitoring is performed by measuring the current in the shield of the AEM electrosurgical instrument. The internal conductive shield also diverts capacitivley coupled energy back to the generator, away from the patient. If excessive magnitude or a quality indicative of a sparking condition is detected, an indicator is lit on the monitor front panel and the signal inhibits the ESU (electrosurgical unit) output using the ESU contact quality monitoring circuit. Connection is made to the ESU contact quality monitoring circuit via a jumper cord. A cord connects the AEM instrument to the monitor and to the ESU output via an adapter. Setup indicators are driven by isolating continuity monitors. These provide checks to ensure the adapters and cable assembly are properly connected. AEM monitor models, cables and adapters are available for mechanical and electrical compatibility with various ESUs, as well as for footswitching and handswitching monopolar instruments, and bipolar instruments. Minor mechanical and electrical changes may be made to optimize interface with compatible ESUs and instruments, which do not affect the safety and efficacy of the system. There is no change to the active electrode monitoring function, including the detection circuitry and instrument interface.

Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.

The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The AEM Monitoring System, with compatible electrosurgical instruments, is designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrode has a stainless electrode tip welded onto the distal ID of the active tube. The active tube acts as the suction and irrigation path. The tube assembly has primary and secondary insulation layers which separate the inner active tube from the outer shield tube. The device has a molded body that interfaces with the 30 party trumpet valves or luer valves via the appropriate adapter. The Adapters (sold separately) are attached to the body of the electrode to make a compatible connection with selected suppliers of trumpet valve/tube sets. There is an electrical connector on the body capable of accepting Encision AEM cords, which carry the active and AEM shield conductors. The electrode has various fixed tips at the distal end for surgical manipulation and delivery of electrosurgical energy to the patient. All tip styles are insulated from the end of the active tube to the working portion of the tip. There is a sliding sheath outside of the tube assembly. The sheath in the extended position minimizes risk of injury to tissue from tips when the electrode is inserted into a trocar cannula or reoriented. Holes in the distal end of the tube facilitate suction when the sheath is extended. When the sheath is retracted the electrode tip is exposed for delivery of electrosurgical energy. The sheath can be locked into place in the extended position, and has tactile stops in both the extended and retracted positions. The sheath is required for full protection from stray energy.

AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment. AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized. The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The material of the molded tip insulation has been changed. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the electrode shaft. The electrodes snap into the handpiece. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field. The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.

The Encision Disposable Handle Assemblies are used for minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.

The DH0100 series and DH0500 series Disposable Handle Assemblies are fully disposable surgical instruments which are packaged for use without additional setup. The instruments fit standard 5.5mm cannulas. The Disposable Handle Assemblies are available in various operative lengths and styles. Tip styles include scissors, and double action and single action forceps and jaws for dissection or grasping. The handle and trigger open and close the working tip of the instrument. The rotation knob turns to allow 360°orientation of the tip as the surgeon prefers. This device does not transmit electrosurgical energy. There is no connection for monopolar or bipolar output from a generator. However, the shaft is insulated, in the event the instrument comes into contact with an active instrument, to prevent stray energy burns. The assembly is supplied sterile and is not intended for more than one use.

The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized. The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece. One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field. The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.