IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)

The IntelliVue Patient Monitors 6100, 6300, and 6500 are multiparameter display units with built-in CPUs designed to monitor and record multiple physiological parameters (ECG, SpO2, NIBP, IBP, temperature) and generate alarms for adults, pediatrics, and neonates. They feature touchscreen interfaces, integrated measurements, compatibility with external modules including Medtronic's NanoPod capnography and a Predictive Temperature Module, and can communicate with central stations. The devices serve as stationary monitors and portable monitors for in-hospital transport only.

The subject devices use the same IntelliVue Software platform as the predicate but add updated electronic components, a new FlexLink connector for external modules, chemically strengthened glass, and modified plastic for disinfectant resistance. They integrate ECG/Resp, SpO2, NIBP, IBP, and Temperature measurements directly rather than only through external modules. Software version R.00.01 includes new hardware integration features, user interface optimizations, cybersecurity enhancements, and a Clinical Monitoring Analytics application, but measurement specifications, algorithms, and performance characteristics remain unchanged from existing IntelliVue monitors.

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-8:2006, IEC 60601-2-25:2011, IEC 60601-2-27:2011, 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, IEC 62304:2006, IEC 62133-2:2017, and UL 2054.

The subject devices are substantially equivalent because they employ the same software platform, measurement principles, and algorithms as the predicate MX550; the integrated measurements and external module compatibility provide the same physiological parameters already available on the predicate through its external module connections. While the subject devices feature updated hardware components, new connectors, and software enhancements, these represent evolutionary improvements rather than fundamental technological changes, and performance specifications for all measurements remain unchanged. Testing against recognized IEC standards and clinical validation of the SpO2 technology demonstrate that the devices do not raise new safety or effectiveness questions.