eMotus Respiratory Motion Management System

The eMotus Respiratory Motion Management System is a device that measures and records a patient's respiratory waveform using optical fiber sensors placed on the chest or abdomen. It provides gating signals to coordinate radiation therapy delivery and diagnostic imaging with the patient's breathing cycle, helping to minimize image artifacts and improve treatment accuracy when respiratory motion is a concern.

The eMotus uses optical fiber strain sensors placed on the patient's skin with adhesive backing, whereas the predicate device uses load cell strain gauges with an elastic belt. Both systems convert sensor data into respiratory waveforms that support threshold-based and phase-based gating. Both have similar latency (≤50ms), compatible gating methods, power requirements, and operating environments, but differ in sensor technology and patient-contacting materials.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation), IEC 60601-1:2005 and amendments (electrical safety), IEC 60601-1-2:2014/AMD1:2020 (EMC), and FDA Guidance on Device Software Functions (2023). The device also underwent biocompatibility, electrical safety, EMC, cybersecurity, human factors, and bench performance testing.

Although the eMotus uses optical fiber sensors instead of the predicate's strain gauge technology, both systems achieve the same functional outcome: monitoring respiratory motion and outputting gating signals to external medical devices. Bench performance testing demonstrated that both devices produce equivalent respiratory waveforms and meet identical signal latency requirements. The difference in sensor technology does not raise different safety or effectiveness questions because the sensors perform the same physiologic function and the data is processed identically downstream. All other technological differences (materials, power, software) are routine variations that do not affect safety or effectiveness.