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510(k) Data Aggregation

    K Number
    K221338
    Device Name
    F&P Airvo 3
    Manufacturer
    Fisher & Paykel Healthcare
    Date Cleared
    2023-01-27

    (263 days)

    Product Code
    QAV, BTT
    Regulation Number
    868.5454
    Why did this record match?
    Product Code :

    QAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities. The Airvo 3 provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.
    Device Description
    The F&P Airvo 3 is a high-flow device comprised of heated humidifier with integrated flow source, intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required). The F&P Airvo 3 can be reprocessed for use on multiple patient interfaces, heated breathing tube, and water chambers are disposable and are for single patient use only, however, the internal outlet elbow is high-level-disinfected for multi-patient use. The F&P Airvo 3 is comprised of two main connected functional units: the blower and the humidifier. The blower is a motorized fan assembly that provides air flow. The flow is adjustable, where a separate source of oxygen independently controlled can be input and mixed with the entrained air. The blower assembly output connects directly to a humidification chamber at the front of the device. The second functional unit of the F&P Airvo 3 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
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    K Number
    K221318
    Device Name
    HVT 2.0
    Manufacturer
    Vapotherm Inc.
    Date Cleared
    2022-12-13

    (221 days)

    Product Code
    QAV
    Regulation Number
    868.5454
    Why did this record match?
    Product Code :

    QAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).
    Device Description
    The HVT 2.0 System is comprised of hardware containing software, and single use disposables that are designed to deliver the same High Velocity Nasal Insufflation (HVNI) as the Vapotherm Precision Flow HVNI. The HVT 2.0 system consists of the HVT 2.0 hardware containing software, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows 5 to 45 L/min (BTPS) to spontaneously breathing patients, without the need of wall air or any pressurized air source. The addition of an external oxygen source (wall or tank for QAV indication) enables FiO2 delivery from 21% to 100%. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently. The HVT 2.0 main hardware device contains all the electrical and electronic components including the electronic blender and flow controllers, and sensors to monitor the disposable patient circuit. The main hardware device has no water pathways and the gas pathway only contains dry gas at room temperature, and therefore does not require internal cleaning or disinfection.
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    K Number
    DEN170001
    Device Name
    Precision Flow® HVNI
    Manufacturer
    VAPOTHERM, INC.
    Date Cleared
    2018-04-10

    (462 days)

    Product Code
    QAV, OAV
    Regulation Number
    868.5454
    Why did this record match?
    Product Code :

    QAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.
    Device Description
    The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains: - Water path: tubing from sterile water supply to vapor transfer cartridge - . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm) - Delivery Tube: triple lumen tubing - . Nasal Cannula The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.
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