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510(k) Data Aggregation

    K Number
    K232627
    Device Name
    HotDog Warming Mattress + Return Electrode
    Manufacturer
    Augustine Temperature Management, LLC
    Date Cleared
    2024-04-18

    (233 days)

    Product Code
    DWJ, GEI
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Augustine Temperature Management, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not mantain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors. The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The HotDog Return Electrode Mattress is intended for use with adult patients only.
    Device Description
    The HotDog Warming Mattress + Return Electrode (“Mattress") is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
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    K Number
    K230866
    Device Name
    HotDog Warming Mattress + Return Electrode
    Manufacturer
    Augustine Temperature Management, LLC
    Date Cleared
    2023-06-29

    (92 days)

    Product Code
    DWJ, ODR
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Augustine Temperature Management, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospital centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors. The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.
    Device Description
    The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
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    K Number
    K220941
    Device Name
    HotDog Temperature Management System
    Manufacturer
    Augustine Temperature Management
    Date Cleared
    2022-09-23

    (176 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Augustine Temperature Management

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not mantain a state of normothermia. The System can be used with adult and pediatric patients. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.
    Device Description
    The HotDog Temperature Management System (“System”) is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages. Unintended hypothermia can occur for many reasons, the most common clinically being the use of anesthetic drugs in surgery. Given the negative consequences of unintended hypothemia, active warming therapy is standard practice. The System can measure patient core temperature within the range of 31°C to 43 C° (87.8°F to 109.4°F). The System consists of the HotDog Temperature Management Controller (WC7X) and reusable Warming Blankets (BXXX) and Mattresses (UXXX). The Controller includes: 7-inch touchscreen with intuitive user interface Ability to power multiple warming devices at once Integrated educational slide shows & positioning guides Adjustable settings Additionally the controller monitors patient core temperature when receiving a signal from an Augustine YSI 400-compatible temperature probe. This requires at least a proprietary cable to make the connection. The Controller can also output the patient temperature to a third-party monitor (e.g., to port to the EMR). AUTO mode is available if Warming Devices are placed on the patient and plugged-in, and a valid human temperature is measured/monitored. AUTO mode automatically adjusts the warming device temperature setting based on a user-selectable "Normothermia Zone" in increments described in the table below. The upper limit in the example below is set at 38 C and lower limit is set at 36 C for the Normothermia Zone (selectable in the Menu -Setting - Temperature Graph; the zone must extend 1°C or greater). Blankets and mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass). They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. They are powered by a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.
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    K Number
    K210727
    Device Name
    HotDog Warming Mattress + Return Electrode
    Manufacturer
    Augustine Temperature Management LLC
    Date Cleared
    2022-02-01

    (327 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Augustine Temperature Management LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.
    Device Description
    The HotDog Return Electrode Mattress is sold with a Return Electrode Cable, 4m (A136) that enables connection to one electrosurgical generator. The HotDog Return Electrode Mattress completes the circuit required for electrosurgery through Capacitive method. A capacitor is created when two conductive plates are separated by an insulator. The separation of two conductive plates by an insulator creates a capacitor. The insulator prevents current from flowing directly between the two plates, thereby avoiding the resistance which creates heat. With capacitive grounding, current from the active electrode produces a charge on the first conductive plate. This causes an equal (but opposite) charge to form on the second conductive plate. Current produced by the charge on the second plate produces electrical returns to the generator and completes the circuit.
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    K Number
    K201779
    Device Name
    HotDog Temperature Management Controller
    Manufacturer
    Augustine Temperature Management
    Date Cleared
    2020-09-11

    (73 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Augustine Temperature Management

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.
    Device Description
    The HotDog Temperature Management Controller is part of a System intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients could become cold. The HotDog Temperature Management Controller is designed to provide power to the HotDog warming devices and to control the devices to set temperature.
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