MR Conditional Cup Electrodes

The MR Conditional Cup Electrodes are cutaneous electrodes consisting of a 10mm ABS disc coated with silver/silver chloride, attached to a conductive lead wire terminating in a connector. They are used for recording electroencephalograms (EEG), evoked potentials (EP), or as ground/reference electrodes. The device is non-sterile, single-patient-use only, and can remain on the patient during MRI or CT scans under specific conditions.

The subject device uses a conductive carbon fiber cable with PVC coating (versus tin-plated copper in the primary predicate), has lead wire lengths of 19.5cm for arrays and 28.2cm for singles, maximum resistance <40Ω for singles and <30Ω for arrays, impedance <500Ω, and supports 2–40 electrodes (up to 10 per array). It is MR conditional at 1.5T and 3.0T with specific SAR and gradient limits. These characteristics are identical or equivalent to the predicate devices in terms of safety and effectiveness.

IEC 60601-1 Clause 8.5.2.3 (electrical safety); ISO 10993-1:2018 (biocompatibility for surface devices >24 hours to ≤30 days); ASTM standards for MR image artifact, magnetically induced displacement force, and magnetically induced torque; ISO/TS 10974 (RF-induced and gradient-induced heating).

The MR Conditional Cup Electrodes are substantially equivalent to the predicate devices because they share identical intended use (EEG/EP recording), classification (21 CFR 882.1320, Class II, product code GXY), materials (ABS 20% glass-filled with Ag/AgCl coating), design (10mm cup electrodes with lead wires and connectors), and MR/CT conditional specifications. Performance testing demonstrates equivalence in functionality, safety, and effectiveness, and no new safety concerns were identified.