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510(k) Data Aggregation

    K Number
    K251598

    Validate with FDA (Live)

    Device Name
    Intellidrop
    Manufacturer
    Date Cleared
    2025-12-10

    (197 days)

    Product Code
    Regulation Number
    882.5550
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intellidrop system is indicated for use to provide external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.

    Device Description

    The Intellidrop system continuously monitors intracranial or spinal pressure and manages external drainage of cerebrospinal fluid (CSF) and other body fluids to a user-selected pressure target or volume target.

    Key features of the Intellidrop include:

    • Wearable sensor array facilitating position-agnostic pressure monitoring
    • Closed-loop, gravity-based drainage to a pressure or volume target
    • Real-time display of intracranial pressure (ICP) waveform
    • Historical trend data of daily, hourly, and minute-by-minute ICP and drainage volume
    • User selectable audio-visual alarm thresholds for both pressure and volume
    • Patented Continuous Drift Detection Technology
    • Continuous operation on AC power and up to 4 hours of continuous operation on rechargeable battery power
    • Real-time data streaming of ICP to a patient monitor via cable
    • Proximal sampling port and optional distal sampling port
    AI/ML Overview

    N/A

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