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510(k) Data Aggregation

    K Number
    K121225
    Device Name
    HAMILTON-C2
    Manufacturer
    HAMILTON MEDICAL AG
    Date Cleared
    2012-11-16

    (207 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K102775,K103803,K120670,K093632
    Predicate For
    K123637,K140939,K163127
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

    Intended areas of use:

    • In the intensive care ward or in the recovery room.
    • During transfer of ventilated patients within the hospital.

    The HAMILTON-C2 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

    Device Description

    The HAMILTON-C2 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C2 is also able to ventilate infants and neonates. The HAMILTON-C2 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, HAMILTON-G5, and HAMILTON-T1, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C2 includes the ASV ventilation mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.

    The HAMILTON-C2 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMILTON-C2 offers ventilation modes that provide full and partial ventilatory support.

      1. The HAMILTON-C2 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+ with IntelliSync, and PSIMV+ without IntelliSync.
      1. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
      1. The new HAMILTON-C2 offers the mode option of both "PSIMV+ with IntelliSync" and "PSIMV+ without IntelliSync". In the previously cleared version of the HAMILTON-C2, the only version of PSIMV+ that was included had IntelliSync.
      1. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
      1. Because some clinicians prefer to set the rate and the inspiration time Ti and other clinicians prefer to set the rate and the inspiration-expiration ratio I:E to define the timing of mandatory breaths in controlled modes. Therefore, both options are available in the proposed HAMILTON-C2
    AI/ML Overview

    The provided text describes a 510(k) summary for the HAMILTON-C2 ventilator. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the ventilator's features and compliance with relevant standards. It does not contain information about acceptance criteria and a study specifically proving the device meets those criteria in the context of an AI/algorithm.

    Therefore, I cannot provide the requested information. The document is for a medical device (ventilator) and does not discuss AI/algorithm performance.

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