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510(k) Data Aggregation

    K Number
    K243900
    Device Name
    eMotus Respiratory Motion Management System
    Manufacturer
    EmpNia Inc.
    Date Cleared
    2025-06-27

    (190 days)

    Product Code
    LHN, IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EmpNia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EmpNia eMotus system is used to measure and record the patient's respiratory waveform to aid with respiratory-synchronized image acquisition or reconstruction during CT diagnostic imaging or radiation treatment planning procedures, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with organ position verification for radiation therapy treatment using CT or Xray imaging by monitoring the patient's respiratory waveform during the image acquisition, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with radiation therapy treatment, where there is a risk of respiratory motion compromising the resulting treatment accuracy.
    Device Description
    The eMotus Respiratory Motion Management System ("eMotus system") is designed to monitor patient respiratory motion and to provide information about this respiratory motion to an external medical device system, such as a radiation therapy delivery device (TDD) or a diagnostic imaging device (DX). The main components of the eMotus system include: - Sensor pad with optical fiber sensors, - Optical fiber cables, - Optical transceiver, - Data acquisition computer with eMotus software application, - Communication modules for compatible external systems, and - Cables to allow data transmission between the components. The sensor pad is a single-use, disposable component with an adhesive backing that is placed directly on the patient's thorax or abdomen. The sensor pad is attached to optical fiber cables that connect to the optical transceiver, which collects optical signal data based on deflection of the sensors in response to respiratory motion. The transceiver digitizes the data and transmits it to the eMotus computer, which visualizes the data as a waveform that can be highlighted when the waveform amplitude reaches a user-specified threshold or the patient's respiratory cycle reaches a user-specified phase. The user can utilize the respiratory threshold and phase information to manually control an external TDD or DX system. When connected to an external TDD or DX, the eMotus system supports the following functions (as applicable given the functions of the external system): - **Threshold-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the amplitude of the respiratory waveform. - **Phase-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the phase of the respiratory waveform cycle. - **Retrospective four-dimensional planning scan:** Delivery of the respiratory waveform to an imaging device to synchronize the waveform data with the scan data, enabling retrospective four-dimensional reconstruction of the imaging session for use in treatment planning. - **Prospective four-dimensional planning scan:** Automatic patient's respiratory waveform are within preset limits, which is used to disable the radiation beam automatically. The eMotus device is an ancillary device and does not provide stand-alone therapy or diagnostic information.
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