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The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional stainless steel scalpel and to minimize blood loss by sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated temperature blade.

The Shaw Scalpel System Controller (Model SG6) is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. The system utilizes a razor-sharp blade coated with proprietary thick-film inks which when used with the handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the Shaw Scalpel System's blade can be adjusted from 70° C to 300° C at the touch of button on the handle or the controller. The Shaw Scalpel System is intended to provide hemostasis as the surgeon incises. The sharpness of the steel blade and scalpel pressure provides the incising action. The steel blade is covered with a black non-stick coating. Below the non-stick coating surface and a layer of insulation is temperature-controlled micro- circuitry which transfers heat uniformly to the entire blade. The Shaw Scalpel System consists of the following main components: a) Controller An electronic power supply/controller that energizes the blade and provides various automatic calibration, sensing, and control functions. It has user controls with visual and audible indications of instrument status. The controller includes software installed on a PCBA. The software monitors the resistance of the blade which it uses to calculate the amount of power needed to be applied to the blade to maintain the temperature setting on the controller. b) Disposable Handle and Blade Both the subject and the Predicate Controllers utilize a sterile disposable scalpel handle and blade, connected to the controller with a light- weight, flexible electrical cable for use with disposable blades. Handles and blades were cleared via 510 (k) K002021. c) Footswitch An optional footswitch is available for use with the Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes. The footswitch was cleared via K091107.