IceCap product line

The IceCap product line consists of single-use, non-sterile EEG electrode caps (IceCap 2, IceCap 2 Small, and IceCap Neonate in sizes XS, S, and M) designed to record electroencephalographic signals from patients with neurological disorders. The caps are placed on the patient's scalp according to the 10/20 electrode system and connect to marketed EEG recorders via adapters, enabling short or long-term EEG monitoring up to 72 hours.

The IceCap product line differs from predicates primarily in the number and sizing of electrodes to accommodate different patient head circumferences: IceCap 2/2 Small contain up to 21 electrodes for larger patients (≥10 kg, ≥43 cm head circumference), while IceCap Neonate provides 9–11 electrodes in three sizes for neonates and infants. Both use flexible printed circuits with Ag/AgCl conductive inks, silicone adhesive, and conductive gel. The Neon EEG predicate has only 6–10 electrodes and is limited to 12 hours of use, whereas IceCap extends to 72 hours and covers a broader patient population.

IEC 60601-1:2005 and amendments (AMD1:2012, AMD2:2020); IEC 60601-1-2:2014 + A1 (2020); IEC 60601-1-11:2015 and amendment (AMD1:2020). The device was tested for electrical safety, EMC, and home healthcare environment requirements.

The IceCap product line is substantially equivalent because it shares the same intended use (EEG electrode recording), principle of operation (10/20 electrode montage with conductive gel), and core technological characteristics (flexible printed circuit with Ag/AgCl inks and silicone adhesive) as the predicates. The differences—varying electrode counts to fit different head sizes and extended 72-hour duration matching the Neuronaute predicate—do not introduce new safety or effectiveness risks. Performance testing confirms the device safely and effectively captures EEG signals, with electrode number variation being a minor design adaptation that does not affect signal quality or clinical performance.