IntelliVue Measurement Rack 6000 (867317)

The IntelliVue Measurement Rack 6000 (MR6000) is a hardware interface with four slots that connects IntelliVue Plug-in Measurement Modules to IntelliVue Patient Monitors (models 6100, 6300, 6500) to enable monitoring and recording of multiple physiological parameters in adults, pediatrics, and neonates. It serves as an accessory that expands the measurement capabilities of the patient monitors by establishing communication between the modules and monitors.

The MR6000 shares the same software platform, materials (plastic housing resistant to disinfectants), and physiological measurements as the predicate device FMX-4. Key differences include updated electronic components, a new MLink connector (versus MSL on predicate), compatibility with Patient Monitor models 6100/6300/6500 (versus MX750/MX850), direct AC mains power with an integrated power button (versus powered by patient monitors), and support for independent power supply operation.

Device compliance demonstrated against IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-6:2020, IEC 60601-1-8:2006, IEC 80601-2-30:2018, IEC 60601-2-34:2011, ISO 80601-2-55:2018, ISO 80601-2-56:2017, ISO 80601-2-61:2017, and IEC 62304:2006 standards covering electrical safety, electromagnetic compatibility, usability, alarm systems, and software lifecycle processes.

The MR6000 is substantially equivalent to predicate FMX-4 because both devices perform identical functions—enabling interoperability between plug-in measurement modules and patient monitors—support the same physiological measurements, use the same software platform, and have identical intended use and indications for use. Bench testing (electrical safety, EMC, software, human factors, interoperability) demonstrated no new safety or effectiveness issues compared to the predicate, and no clinical trials were required.