Delphi MCS Electrode Cap

The Delphi MCS Electrode Cap is an EEG electrode set designed for rapid placement of multiple electrodes on a patient's head in routine clinical settings. It consists of an elastic textile cap with integrated Ag/AgCl electrodes positioned according to the international 10-20 system, available in five adult sizes (M through XL), and secured with a chinstrap.

Both the subject device and predicate (Electro-Cap System) feature an elastic fabric cap with plastic electrode mounts, Ag/AgCl sensors, detachable electrodes, and maximum impedance of 5 kΩ. Key differences include: subject device uses neoprene vs. predicate's spandex; polyurethane mounts vs. polyethylene; external wiring vs. internal; up to 32 electrodes vs. 256; and cable lengths of 1.2-1.8 m vs. 0.9-1.5 m. Both use standard ribbon and lead wires with D-sub or similar connectors.

Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), and ISO 10993-23:2021 (irritation). Electrical safety per IEC 60601-1. Device also underwent use cycle reliability testing, AC impedance, offset voltage, bias current tolerance, and shelf-life testing.

The subject device shares identical intended use with the predicate—rapid placement of EEG electrodes in clinical settings. Although material and design differences exist (neoprene vs. spandex, external vs. internal wiring, fewer electrodes), these differences do not introduce new safety or effectiveness concerns and are supported by equivalent biocompatibility and electrical safety testing. All performance parameters, electrode sensor technology, and operational principles remain substantially similar to the predicate.