IntelliVue Patient monitors MX400, MX450, MX500, MX550

The IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 are multiparameter bedside monitors that acquire physiological signals (ECG, SpO2, blood pressure, temperature, and others), display measurements and trends, generate alarms, and record patient data. They are intended for use by healthcare professionals in hospitals to monitor adults, pediatrics, and neonates, and are not for home use.

The subject devices have the same hardware design and IntelliVue software platform as their predicate, with minor software enhancements for functionality and the addition of a new FloTrac plug-in module (P/N 867409) for MX500/MX550 models to interface with Edwards Lifesciences pressure cables and sensors. The new module acts as a communication interface without altering data content. Three older measurement modules (M1019A, M1013A, M1014A) are no longer supported.

IEC 60601-1:2005 (general safety and essential performance), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-1-6:2010 (usability), IEC 60601-1-8:2006 (alarm systems), and IEC 62304:2006 (medical device software life-cycle processes).

The subject devices are substantially equivalent because they maintain the same intended use, operating principle, hardware design, and core physiological measurements as the predicate device K223574. Software enhancements address only existing functionalities and add compatibility with the new FloTrac module without introducing new safety or effectiveness concerns. Non-clinical bench testing, electrical safety, and electromagnetic compatibility testing demonstrate no new safety or effectiveness issues.