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    K Number
    K103317
    Device Name
    RESUSCITATION UNIT 105
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-04-20

    (161 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K925982,K053232,K060461,K070210
    Why did this record match?
    Device Name :

    RESUSCITATION UNIT 105

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

    The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.

    Environment of use - Hospitals, delivery suites, NICU

    Device Description

    There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.

    • Resuscitation Unit 105PV .
    • . Resuscitation Unit 105EV
      They have the same basic design. Table 1 outlines the basic features and differences of each model.
    AI/ML Overview

    The Atom Medical Corporation Resuscitation Unit 105EV and 105PV are medical devices intended to remove secretions from neonatal/infant airways and to provide blended air and oxygen at a desired concentration (21-100%) to respiratory assist devices. The devices underwent performance testing to demonstrate substantial equivalence to predicate devices.

    1. Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (from predicate devices)Reported Device Performance (Resuscitation Unit 105EV/PV)
    Air/O₂ blender:
    • Range: 21-100%
    • Accuracy: ±3%O₂ | Achieved 21-100% oxygen concentration with ±3%O₂ accuracy (implied by substantial equivalence to predicates like Bio-Med Devices BMD air/oxygen blender K925982 and Precision Medical Precision Blender K053232). |
      | Airway pressure manometer:
    • Range: -20 to 80cmH₂O
    • Accuracy: ±1% of full scale | Achieved -20 to 80cmH₂O range with ±1% of full scale accuracy (implied by substantial equivalence to Atom V-505 Infant Warmer K060461, which features an airway pressure manometer). |
      | Relieving valve:
    • Set to 5.9 kPa (60 cmH₂O) for preventing excessive airway pressure | The device has a relieving valve with a default setting of 5.9kPa (60cmH₂O), which is a feature not present in some predicates, indicating it meets or exceeds this safety aspect. |
      | Gas sources input pressure:
    • Air/O₂: 206-517kPa | Achieved 300-500kPa (which falls within the predicate's range of 206-517kPa and implies compliance). |
      | Gas flow rate range (blender):
    • ≥ 30 lpm (for certain predicates) |
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