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The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.

Indications: General, urologic, thoracic, plastic/reconstructive, gynecologic, laparoscopic and arthroscopic surgical procedures.

This device is used to activate the CUT and COAGULATE modes of an electrosurgical generator in order to cut soft tissue via a handheld push button or rocker switch controlled electrosurgical pencil. The body of the device has a molded plastic housing with either two buttons (one for cut and one for coagulate) or a rocker switch located at the distal end of the pencil. A ten foot cable exiting the housing features a universal three prong plug allowing the pencil to be connected to the monopolar side of a standard electrosurgical generator. A PTFE coated electrode or an uncoated stainless steel electrode will be packaged with this device with the option of including an insulated holster.

The Holster serves as an insulated container to store the pencil while it is inactive in order to avoid accidental activation when not in use. The holster conveniently attaches to a surgical drape.

The uncoated stainless steel electrode is used to cut and coagulate soft tissue. The PTFE coated electrode is a stainless steel electrode coated with a non-stick material (PTFE), which is also used to cut and coagulate soft tissue. The PTFE coating reduces the build up of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup.

This device is a single use, disposable device which will be sold sterile and bulk nonsterile to be sterilized by the customer. Electrode tips are also single use, disposable devices which may be sold individually sterile or bulk non-sterile to be sterilized by the customer.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for an electrosurgical pencil, primarily focusing on its equivalence to a predicate device and its intended use. There are no details regarding specific performance metrics, test methods, sample sizes, or expert involvement in a study.

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