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510(k) Data Aggregation

    K Number
    K251974
    Manufacturer
    Date Cleared
    2025-10-24

    (120 days)

    Product Code
    Regulation Number
    870.5900
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

    Device Description

    The Arctic Sun™ Temperature Management System Model 5000 is a non-invasive, thermal regulating device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The system consists of a console, non-sterile single patient use ArcticGel™ Pads, and associated accessories.

    The Arctic Sun™ Temperature Management System Model 5000 circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ Pads, resulting in heat exchange between the water and the patient. A commercially available Yellow Springs Instrument (YSI) 400 series compatible patient temperature probe connected to the console provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Model 5000 console has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, which are USB and RS-232, do not allow the user to write to the device and are intended for user convenience only.

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