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510(k) Data Aggregation

    K Number
    K251275
    Device Name
    VitalStream ART Connect; VitalStream-Hemo
    Manufacturer
    Caretaker Medical
    Date Cleared
    2025-09-26

    (155 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K181196,K211588,K163255,K151499,K213699,K181372
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VitalStream ART Connect (aka VitalStream-Hemo) provides calibrated cardiac output/stroke volume (CO) and derived parameters, including cardiac index (CI), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA") (K211588, K163255, K151499). The device is intended for use on adult patients by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

    Device Description

    The VitalStream ART Connect is an adapter to accept the analog output channel of commercial invasive arterial catheter blood pressure monitors. An on-board analog to digital converter provides access to a digitized version of the raw invasive blood pressure signal and presents it to the Caretaker Platform (K211588) to provide the same parameters that were previously obtained through a filtered pneumatic signal (Caretaker Advanced Hemodynamic Parameters, K213699).

    AI/ML Overview

    N/A

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