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510(k) Data Aggregation

    K Number
    K131502
    Device Name
    SEATTLE - PAP
    Date Cleared
    2013-10-11

    (140 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEATTLE CHILDRENS HOSPITAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician. It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).
    Device Description
    Seattle-PAP is a bubble continuous positive airway pressure (CPAP) device. Seattle-PAP is installed at the end of an expiratory limb, distal to the patient, in a continuous gas flow breathing system. Seattle-PAP is intended to assist spontaneous breathing in neonates and infants, up to weights of 10 kg. Seattle-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a Lid permanently attached to help prevent splashing and spillages. The Lid has an integrated Water Level Adjustment Port, so a clinician can adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit. The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally. The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. These pressure oscillations do not adversely affect the performance of the Seattle-PAP device, i.e. the ability to deliver the desired CPAP pressure accurately.
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