The SudoPath system is a programmable electro medical device namely a USB plug and play hardware including and electronic box, cables and reusable electrodes and associated software for assessment of sudomotor function using galvanic skin response measurements.
The SudoPath patented measurement process is an improved sympathetic skin response method following a constant electrical stimulation, and provides a quantitative evaluation of the sweat response according to the redox (reduction/oxidation) measurements on the bulk of the electrodes.
The sweat response is evaluated in 4 sites of the body with highest density of eccrine sweat glands - the palms of the hands and soles of the feet.
Through the protocol communication, the software manages the time and sequence of electrical stimulation as follows:
1. Left to right foot 15 seconds / change in current direction from right to left foot 15 seconds
2. Right to left foot 15 seconds / change in current direction from left to right foot 15 seconds
3. Left to right hand 15 seconds / change in current direction from right to left hand 15 seconds
4. Right to left hand 15 seconds / change in current direction from left to right hand 15 seconds
The software displays the change of the conductance values of the patient in real time and manages and analyzes the data.
The data are stored in the backup system of the software, and the history of the data can be displayed for the same patient with different dates.
Intended use and indications for use
SudoPath is a medical device for the measurement of galvanic skin response.
The SudoPath device provides values. It is the physician's responsibility to make proper judgments based on these numbers.
The device is indicated for use with the general adult population.
Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician
Notes! After opinion of experts regarding the description of the method of measurement of the SudoPath system, our suggested assumption that at the anode there is a release of chloride ions has been reviewed. In fact, it has been proven that the activation energy for the chloride ion is very low. In other words, although the voltage applied is thermodynamically sufficient to drive electrolysis, the rate is so slow that to make the process proceed in a reasonable time frame, the voltage of the external source has to be increased (General Chemistry: Media Enhanced Edition by Darrell Ebbing, Steven D. Gammon), and SudoPath has a constant voltage.
In addition, there is a competition between the negative ions at the positive anode. The chloride ions compete with the hydroxide ions to release their electrons to the anode. Regarding the very low concentration of chloride ions in the sweat (0.2 to 0.5%), OH- ions are preferentially released at the anode.
Therefore, only the OH- ions and water are oxidized at the anode.
This fact does not affect the clinical evaluation or the effectiveness and data analysis of the SudoPath based only on skin conductance measurements.
FDA Clearance 510K number k131568