Telemetry Monitor 5500 Release 4.0 (867232)

The Telemetry Monitor 5500 Release 4.0 is a battery-operated, patient-worn monitor with a touchscreen display that monitors and records multiple physiological parameters—including ECG, SpO2, and respiration rate—in hospitalized adults and pediatric patients and during in-hospital transport. It communicates wirelessly via 1.4 GHz radio to a central Patient Information Center and is not intended for home use.

The subject device has an updated user interface with a modernized exterior and graphical display improvements; improved battery runtime (8–31 hours for ECG-only mode with Lithium-ion vs. 9–30 hours in predicate); end-to-end data encryption and authentication via Smart-hopping 2.0 (new feature); simplified battery door design eliminating the need for a separate door when using Lithium-ion batteries; and an integrated acoustic back volume in the speaker assembly. Physiological parameters, accessories, and core monitoring algorithms (EASI, Hexad, ST/AR) remain identical to the predicate.

IEC 60601-1 (electrical safety), ANSI AAMI IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), ANSI AAMI IEC 62366-1 (usability engineering), ANSI AAMI IEC 60601-1-8 (alarm systems), ANSI AAMI IEC 60601-2-27 (ECG monitoring), IEC 80601-2-49 (multifunction patient monitoring), ISO 80601-2-61 (pulse oximetry), ANSI AAMI IEC 62304 (software lifecycle), and FDA guidance on pulse oximeter 510(k)s.

The subject device has identical intended use, patient population, physiological parameters monitored, ECG/SpO2 accessories, and core arrhythmia detection algorithms as the predicate MX40. Functional testing confirms equivalent accuracy performance. Minor technological differences—improved battery life, user interface modernization, and added cybersecurity features—do not alter clinical performance or safety. The simplified battery design was validated through usability testing. Enhanced encryption supports the same wireless communication method and does not raise safety concerns. These improvements represent evolutionary refinements to an unchanged clinical function, preserving substantial equivalence.