Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

The RX-1 mini Rhythm Express Remote Cardiac Monitoring System is a wearable device for patients over 10 kg with cardiac disease or cardiac symptoms. It continuously records two-channel ECG data, detects arrhythmias using an on-board algorithm, and transmits recorded cardiac activity to a monitoring center within 1-7 minutes for physician review. The device does not deliver therapy, administer drugs, or provide diagnostic interpretations.

The RX-1 mini shares the same cardiac monitoring modes, ECG algorithm design, ECG performance standard, 2-channel 4-lead input, heart rate range, and event storage as the predicate RX-1 device. Key differences include smaller housing and lighter weight, new patient contact material (lead), simplified user interface with LED and haptic feedback, additional arrhythmia detections (SVEs, VT, SVT), shorter ECG lead length, smaller battery with magnetic charger, and addition of Wi-Fi and Bluetooth interfaces.

Testing followed IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-11:2015, IEC 60601-2-47:2012, IEC 62304:2006, IEC 62366-1:2015, IEEE C63.27-2017, IEEE C95.1-2005, ISO 10993 series (biocompatibility), ISO 14971:2019 (risk management), and ANSI AAMI standards for ECG electrodes and cardiac rhythm measurement algorithms.

The RX-1 mini has identical intended use and indications for use as the predicate RX-1 device. Although the mini version is smaller, lighter, has enhanced detection capabilities (SVE, VT, SVT), simplified user interface, and new wireless connectivity, these differences do not raise new safety or effectiveness questions because the core ECG monitoring, analysis algorithm, and data transmission functions are substantively preserved. Performance testing demonstrates the RX-1 mini meets the same performance specifications as the predicate, establishing safety and effectiveness equivalence.