CAIs Sensor (CAIs-001)

The CAIs Sensor (CAIs-001) is a disposable, pre-gelled cutaneous electrode array with four electrodes arranged in a circle, applied to the patient's skin to record electrophysiological signals such as EEG. It is a single-patient-use, low-impedance device designed for frontal/temporal area application and works in conjunction with CAI Monitoring System software.

The CAIs Sensor has substantially the same major characteristics as the predicate BIS Sensor, including the same design (circle-shaped, four-electrode array), application method (direct skin contact), intended use (EEG recording), and material composition. Both are single-patient-use, disposable electrodes with hydrogel adhesive.

Biocompatibility testing per ISO 10993-1:2018, 10993-5:2009/(R)2014, 10993-10:2021, 10993-23:2021. Bench testing per FDA Guidance on Cutaneous Electrodes and standards ANSI/AAMI EC12:2000/(R)2015, IEC 60601-2-2 (2016). Risk analysis and usability engineering also performed.

The CAIs Sensor is substantially equivalent because it has the same indications for use as the predicate (recording electrophysiological signals from skin), is applied using the same method (direct skin contact), and demonstrates the same major safety and performance characteristics through non-clinical testing including biocompatibility, electrical performance, and adhesive durability. The technological comparison confirmed no material differences affecting safety or effectiveness.