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510(k) Data Aggregation

    K Number
    K242525
    Device Name
    iTOF®
    Manufacturer
    Nerbio Medical Software Platforms, Inc.
    Date Cleared
    2024-12-05

    (101 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nerbio Medical Software Platforms, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iTOF is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
    Device Description
    The iTOF is an accelerometery based Quantitative Neuromuscular Blockade Monitor that provides continuous, non-invasive neuromuscular transmission (NMT) monitoring by measuring the acceleration of muscle movement (acceleromyography) during controlled electrical stimulations. The iTOF allows medical professionals to accurately monitor and evaluate the depth of neuromuscular blockade of an adult or paediatric patient in the intensive care ward, operating theatre, or recovery room. It is used by health professionals - anaesthesiologists, doctors, or fully qualified nurse anaesthetists for objective or subjective neuromuscular transmission monitoring. The iTOF system consists of a mobile device app (User Interface Software), a Bluetooth connected nerve stimulation device (Hardware and Firmware) powered by a 9 Volt nonrechargeable battery, an Accelerometer Sensor, and Stimulation Cables. The App displays user interface elements including the various stimulation settings controls, the time elapsed between stimulations (all modes), and the results for the measurements made in response to types of stimulation chosen by the user (TOF, PTC, and DBS) (TET and TWI responses are gauged visually by the health professional). The hardware device portion of the iTOF system provides the electrical stimulation patterns via the Stimulation Cables and quantitatively measures the resulting twitch via the Accelerometer Sensor. The iTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice: TOF (Train Of Four), PTC (Post Tetanic Count), DBS (Double Burst) (3.3), TWI (Single Twitch) (0.1Hz, 1 Hz, 2Hz), TET (Tetanus) (50Hz). The accessories that can be used with the device include: iTOF Splint (included).
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