MRidium 3870 MRI Infusion Pump System (3870)

The MRidium 3870 MRI Infusion Pump System is a volumetric infusion pump designed for use in MRI environments to deliver intravenous fluids and medications in a controlled manner. It operates safely up to 3.0 Tesla MRI systems at magnetic field strengths up to 15,000 Gauss and is intended for adult, pediatric, and neonatal patients undergoing or preparing for MRI procedures.

The proposed device is a single-channel infusion pump with a touchscreen user interface and multi-color LCD display, compared to the predicate's hard-key interface and monochrome display. It operates with an improved magnetic field tolerance (15,000 Gauss vs. 10,000 Gauss), includes encryption for wireless communications, uses a lighter enclosure design, and has an integrated drug library feature rather than optional. The peristaltic pump mechanism delivers 250 µL per rotation versus the predicate's 300 µL, but flow accuracy remains equivalent per AAMI TIR101 standards.

Testing compliance with IEC 60601-1 (general electrical safety), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), AAMI TIR101 (infusion pump flow accuracy), and AAMI/ANSI HE75 (human factors engineering).

The device is substantially equivalent because it maintains the same fundamental intended use (MRI-safe infusion therapy), operating principle (ultrasonic motor-driven peristaltic pump), and essential performance specifications (flow accuracy, occlusion detection, alarm functions) as the predicate. Design improvements—such as increased magnetic field tolerance, touchscreen interface, integrated drug library, and wireless encryption—represent enhancements that do not raise new safety or effectiveness questions. All differences are documented and tested to demonstrate equivalent or superior performance in the MRI environment.