Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

The Welch Allyn Connex Spot Monitor (CSM) is an integrated vital signs monitor used by clinicians to measure noninvasive blood pressure, pulse rate, oxygen saturation (SpO2), body temperature, and respiration rate in neonatal, pediatric, and adult patients. It displays and transmits patient data electronically via USB, Wi-Fi, Bluetooth, or ethernet to hospital information systems and central monitoring stations.

The CSM 1.53 adds Masimo pulse oximetry sensing technology for respiration rate measurement from photoplethysmogram (RRp), an additional Braun Pro 6000 infrared thermometer option, additional barcode scanner options, and additional stand/mounting and weight scale options. All updates were implemented through design controls and verified not to impact device safety and efficacy.

Testing followed IEC 60601-1 (general safety), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarms), ANSI AAMI IEC 80601-2-30 (sphygmomanometers), IEC 80601-2-49 (multifunction monitors), IEC 80601-2-56 (thermometers), ISO 80601-2-61 (pulse oximeters), IEC 62366-1 (usability engineering), IEC 62304 (software lifecycle), and ISO 14971 (risk management), among others.

The CSM is substantially equivalent to predicate K142356 because both are integrated vital signs monitors with the same fundamental intended use and function—measuring and displaying patient vital signs in clinical settings. The addition of respiration rate monitoring via Masimo RRp does not constitute a new intended use; it is an additional measurement parameter within the same class of patient physiological monitoring device. All technological updates were implemented through validated design controls and pose no new safety or efficacy concerns relative to the predicate.