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510(k) Data Aggregation

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    Reference Devices :

    K131912,K234032

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hudson RCI® Infant Dri-Tech™ Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in a professional healthcare environment as a conduit for warmed and humidified respiratory gases between a patient and a ventilator and includes heated wires for use with the Hudson RCI Neptune Heated Humidifier.

    Device Description

    The Hudson RCI® Infant Dri-Tech Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

    The Dri-Tech Infant Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, Cannula and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".

    The dual limb configuration consists of 12mm ID inspiratory and expiratory limbs with 22mm machine side connectors that are compliant to ISO 5356-1:2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets, and 12mm patient side connectors that utilize the same taper and engagement length as ISO 5356-1:2015 connectors. The infant circuits have two length configurations, a short inspiratory that is 1.12m or a long inspiratory that is 1.6m, either of which can be used with an expiratory limb that is 1.7m, and may be kitted with the accessories described below:

    • Accessory Tee with Closure Cap: Optional tubing adaptor for various connections as required.
    • Remote Port Tubing, 6" and 12": Unheated sections of tubing for use with incubators, isolettes, or other ambient heating to ensure the temperature probe is not heated by the environment.
    • Unheated Ventilator Tubing: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

    The single limb configuration is identical to the long version of the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:

    • Unheated Ventilator Tubing: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
    • Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.

    All Hudson RCI Dri-Tech breathing circuit configurations are packaged in polyethylene (PE) bags to protect the devices from environmental influences like dust and moisture. Included in the PE bags are additional PE bags containing ConchaSmart columns (-KIT configurations only) and included accessories. The breathing circuit PE bags are packaged ten (10) to a cardboard carton for all configurations. They are sold non-sterile.

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