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The Hemostatix Thermal Scalpel System Handles and Blades are a surgical instrument designed to retain the precise. clean cutting characteristics of a traditional stainless 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 Hemostatix Thermal Scalpel System (HTSS) 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 Hemostatix handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the HTSS's blade can be adjusted from 70°C to 300°C at the touch of button on the handle or the controller. HTSS 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 HTSS 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 EPROM on the control 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) Footswitch An optional footswitch is available for use with the Model P8400 Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes. c) Handle A disposable scalpel handle, connected to the controller with a lightweight, flexible electrical cable for use with disposable blades. d) Blades Various sizes of sterile disposable scalpel blades similar in size, shape and sharpness to conventional #10, #12, and #15 scalpel blades.

The Model P8400 Hemostatix Thermal Scalpel System 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 Model P8400 Hemostatix Thermal Scalpel System 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 Model P8400 Hemostatix Thermal Scalpel System has the same intended use; the same technological characteristics; power modality; mode of operation: utilizes the same scalpel blades; has many of the same audible sounds and alarms; handles that are sterilized the same way (EO gas); same operating temperature ranges (70° C to 300° C), and, utilizes the same blades as the predicate device, the Hemostatix Model 2400Z Thermal Scalpel System cleared via 510(k) No .: K033089. The Model P8400 Hemostatix Thermal Scalpel System differs from the predicate device in that the Model P8400 Hemostatix Thermal Scalpel System features an aluminum enclosure vs. a thermoplastic enclosure for the Hemostatix Model 2400Z Thermal Scalpel System; requires a different handle with a unique plug-in connector which is not compatible with the Hemostatix Model 2400Z Thermal Scalpel System; will accommodate an optional footswitch to control the functions of the handle and blade; will mount on an IV pole unlike the Hemostatix Model 2400Z Thermal Scalpel System; has one multi-color 4.6 in x 3.4 in TFT display vs. two displays (1.5 in x 3 in - three color and 0.5 in x 3 in monochromatic message center); and is designed to be UL 60601-1 Type BF versus a Type B for the Hemostatix Model 2400Z Thermal Scalpel System.