IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)

The IntelliVue Multi-Measurement Module X3, Patient Monitor MX100, and MMX are multiparameter patient monitors designed for monitoring, recording, and alarming of multiple physiological parameters (ECG, respiration, SpO2, blood pressure, temperature, CO2) in adults, pediatrics, and neonates in hospital environments. The devices display measurement values, waves, and trends; generate physiological and technical alarms; and support patient data management and transfer between monitors.

The subject devices have identical hardware, design, materials, energy sources, physiological parameters, and measurement accessories to the predicate device. Software changes include enhanced STAT mode initiation during NBP measurements, modified NBP factory defaults, improved alarm logging, disabled AlarmsOffAtStart configuration, support for 100Mbps connections, and enhanced speaker malfunction indicators. No new technological hardware features, measurement capabilities, or performance specifications were introduced.

ANSI AAMI ES60601-1:2005/(R)2012 and amendments (general electrical safety), IEC 60601-1-2:2014 with AMD1:2020 (electromagnetic disturbances), IEC 60601-1-6:2010 with amendments (usability), IEC 60601-1-8:2006 with amendments (alarm systems), and IEC 62304:2006 with AMD1:2015 (medical device software life-cycle processes).

The subject devices are substantially equivalent to predicate K230604 because operational and technological characteristics are identical, no new safety or effectiveness issues are introduced, all software changes only enhance existing functionalities without modifying measurement principles or algorithms, and all non-clinical testing including electrical safety, electromagnetic compatibility, and software verification demonstrates equivalent performance and safety profiles to the predicate device.