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510(k) Data Aggregation

    K Number
    K142512
    Device Name
    Personalized Physiology Analytics Engine software
    Manufacturer
    VGBio, Inc (DBA PhysIQ)
    Date Cleared
    2015-06-11

    (276 days)

    Product Code
    PLB
    Regulation Number
    870.2300
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    Applicant Name (Manufacturer) :

    VGBio, Inc (DBA PhysIQ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient's monitored vital signs change from those measured at baseline, which has been derived from measurements previously obtained during routine activities of daily living. The MCI is based on an integrated computation evaluating changes in the parameters and their relationships to each other. The PPA Engine is an adjunct to and is not intended to replace vital signs monitoring. The MCI is intended for daily intermittent, retrospective review by a qualified practitioner. The PPA Engine is intended to provide additional information for use during routine patient monitoring. The MCI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
    Device Description
    The PhysIQ Personalized Physiology Analytics Engine ("PPA Engine") is a computerized analysis software program that is designed for detecting change in the relationships among the patient's vital signs throughout dynamic physical activity, based on data input from multi-parameter vital sign monitoring devices. The PPA Engine first "learns" a patient's personalized baseline, defined by the relationship among the vital signs derived from measurements obtained during routine activities of daily living. Once the baseline vital sign relationships are established, it analyzes the subsequent data to assess how the relationships among the vital signs incoming during the monitoring period compare to the established baseline. The PPA Engine can analyze data collected wherever the patient is monitored, reflecting a patient's activities of daily living. The device is intended for monitoring ambulatory patients. The PPA Engine requires vital sign inputs of Heart Rate (HR), Respiration Rate (RR) and Activity (ACT) (body motion). The PPA Engine can accept input from commercial vital sign monitors or combinations of monitors that can provide multivariate observations of these vital signs. The PPA Engine calculates the Multivariate Change Index (MCI), a scalar index between 0 and 1, which represents the likelihood that the relationships among the patient's vital signs are different from those at baseline, which was established during routine activities of daily living. An MCI value closer to zero (0) indicates that the monitored relationships among the vital signs are similar to the learned baseline. An MCI value closer to one (1) indicates that the patient's monitored relationships among the vital signs are likely to be different from the learned baseline. The MCI is also presented as a time series (MCI over time) and it is intended to for retrospective review by the clinician The MCI is not intended to replace standard patient monitoring. Rather, it was designed to supplement standard monitoring of ambulatory patients.
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