LuMon(TM) System

The LuMon™ System is a noninvasive, non-radiation electrical impedance tomography (EIT) device that monitors regional air content and impedance variation in a patient's thorax to support respiratory assessment. It displays real-time EIT images, waveforms, and derived parameters as an adjunctive tool. The device is indicated for neonatal and infant patients (chest circumference 16.5–50 cm) and adolescent through adult patients (76–128 cm) who are breathing spontaneously or on mechanical ventilation in professional healthcare facilities; impedance-based respiratory rate monitoring is restricted to adults 22 years and older with chest circumference above 76 cm.

The LuMon™ System uses the same EIT operating principle and technology as the predicate Timpel Enlight 2100 but extends to smaller patient populations (neonates and infants) with corresponding smaller belt sizes (16.5–50 cm vs. predicate's 37.5–134 cm). The subject device includes an integrated patient position sensor (automatic measurement vs. predicate's manual GUI entry), one-way connectivity to third-party devices (ventilators and transcutaneous monitors), and displays additional derived parameters (EELI minima trending, Tidal Distribution Image, Center of Variation). The monitor is significantly more compact and portable than the predicate's cart-based system.

IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility; ISO 10993-1 for biocompatibility (surface contact, intact skin, prolonged duration); IEC 62366-1 and AAMI HE75 for human factors and usability validation; FDA guidance on software verification and validation for medical device software.

The subject device shares the same EIT-based operating principle and fundamental technology as the predicate (Timpel Enlight 2100), both measuring regional impedance variation via electrode arrays to assess respiratory mechanics. While the subject device extends to smaller patient populations (neonates and infants) and includes new features (position sensor, connectivity, additional parameters), the submission provides extensive bench, pre-clinical (rabbit and piglet models spanning 19–50 cm), and clinical validation demonstrating equivalent or superior performance for the expanded populations. Pre-clinical studies confirmed EIT accuracy against CT imaging with R² correlations of 0.97–0.98, and clinical studies in healthy volunteers and ICU patients validated regional distribution measurements against the predicate and respiratory rate accuracy against capnography references. The technological differences (e.g., position sensing, connectivity) are additive and do not raise new safety or effectiveness questions; all parameters display equivalent ranges and accuracy specifications, and the device meets identical electrical safety and biocompatibility standards.