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510(k) Data Aggregation

    K Number
    K173032
    Device Name
    Paxman Scalp Cooler
    Date Cleared
    2018-06-07

    (252 days)

    Product Code
    Regulation Number
    878.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Paxman Coolers Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.
    Device Description
    The Paxman Scalp Cooler is a self-contained, mobile, electrically-powered refrigeration unit that circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap, which is fitted to the top of the patient's head and connected to the refrigeration unit by a pair of coolant lines. A touchscreen controller with a menu-driven, graphical user interface, integrated into the refrigeration unit, allows the healthcare professional to initiate, monitor, and complete the scalp cooling process.
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    K Number
    K163484
    Device Name
    Paxman Scalp Cooler
    Date Cleared
    2017-04-17

    (126 days)

    Product Code
    Regulation Number
    878.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Paxman Coolers Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer.
    Device Description
    The Paxman Scalp Cooler is a self-contained, mobile, electrically-powered refrigeration unit that circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap, which is fitted to the top of the patient's head and connected to the refrigeration unit by a pair of coolant lines. A touch screen controller with a menu-driven, graphical user interface, integrated into the refrigeration unit, allows the healthcare professional to initiate, monitor, and complete the scalp cooling process. Two (2) models of the Paxman Scalp Cooler are available: - . ORBIS I – featuring one pair of coolant lines for attaching a single cooling cap; designed for scalp cooling of one patient at a time; and, - . ORBIS II – featuring two pairs of coolant lines for attaching two cooling caps; designed for scalp cooling of up to two (2) patients at a time. The touch screen displays a menu-driven Graphical User Interface (GUI) that provides information to the user concerning the operational status of the scalp cooling unit; it also prompts the user to initiate certain actions relating to the scalp cooling procedure and provides a timer count-down function for scalp cooling sessions. The GUI does not, however, directly control the scalp cooling process as there are pre-established programs for the scalp cooling administration. The touch screen controller provides feedback to the user concerning the status of the Paxman Scalp Cooler as it relates to achievement of the pre-set temperature of the coolant, operation of the recirculation pump and connection of a cooling cap to the software also provides a timer count-down function for the initiated pre- and post-infusion cooling procedure. At the pre-set time, a message is displayed on the touch screen and a buzzer sounds to alert the fact that the scalp cooling time is complete.
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