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510(k) Data Aggregation

    K Number
    K193415
    Device Name
    physIQ Heart Rhythm and Respiration Module
    Manufacturer
    Date Cleared
    2020-06-11

    (185 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    physIQ, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The physIQ Heart Rhythm and Respiration Module (Version 3.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module is intended to be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display). The physIQ Heart Rhythm and Respiration Module may only be used with FDA-cleared, chest-worn biosensors using "wet electrode" technology that capture single-lead digital ECG data at 125Hz or higher and integrated triaxial accelerometer data at 15Hz or higher and that are recorded in a compatible format for analysis. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.
    Device Description
    The physIQ Heart Rhythm and Respiration Module (Version 3.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physlQ Heart Rhythm and Respiration Module (3.0) will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the physIQ Heart Rhythm and Respiration Module (3.0) to input ECG and triaxial accelerometer data for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.
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    K Number
    K183322
    Device Name
    physIQ Heart Rhythm and Respiratory Module
    Manufacturer
    Date Cleared
    2019-07-10

    (222 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    physIQ, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The physIQ Heart Rhythm and Respiration Module (Version 2.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.
    Device Description
    The physIQ Heart Rhythm and Respiration Module (Version 2.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physIQ Heart Rhythm and Respiration Module will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the phys/Q Heart Rhythm and Respiration Module to input ECG and triaxial accelerometer data for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.
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