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    K Number
    K223086
    Device Name
    Ceribell Instant EEG Headcap
    Manufacturer
    Ceribell, Inc.
    Date Cleared
    2023-03-22

    (173 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Abbreviated
    Panel
    Neurology
    Reference & Predicate Devices
    K200162
    Why did this record match?
    Device Name :

    Ceribell Instant EEG Headcap

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

    The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

    Device Description

    The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

    The Ceribell Instant EEG Headcap is comprised of the following components:

    • An elastic fabric headcap
    • An elastic chin strap
    • A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes
    • A cable attached to the headcap to allow connection to an EEG acquisition/recording device
    AI/ML Overview

    The Ceribell Instant EEG Headcap is a cutaneous electrode device. The provided text outlines the acceptance criteria and performance data for this device, comparing it to a predicate device (Wuhan Greentek Disposable EEG Electrodes, K200162) to establish substantial equivalence.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Ceribell Instant EEG Headcap are based on the same requirements as its predicate device and defined by FDA-recognized consensus standards, primarily ANSI/AAMI EC12 Disposable ECG Electrodes and ISO 10993 series for biocompatibility.

    AttributeAcceptance Criteria (Standard)Reported Device Performance
    Electrical Performance
    Average AC Impedance≤ 2 kΩ (individual pairs ≤ 3kΩ) (ANSI/AAMI EC12)Met the same requirements per FDA guidance document.
    DC Offset Voltage≤ 100 mV (ANSI/AAMI EC12)Met the same requirements per FDA guidance document.
    Combined Offset Instability and Internal Noise≤ 150 μV (ANSI/AAMI EC12)Met the same requirements per FDA guidance document.
    Bias Current Tolerance (DC Voltage Offset)≤ 100 mV (ANSI/AAMI EC12)Met the same requirements per FDA guidance document.
    Biocompatibility
    CytotoxicityISO 10993-5Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1".
    Sensitization, Irritation or Intracutaneous ReactivityISO 10993-10Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1".
    Electrical Connection ComplianceConductive Connection Compliance per ES 60601-1, IEC 60601-1 clause 8.5.2.3, 21 CFR 898.12Met the same requirements per FDA guidance document.
    Shelf LifeANSI/AAMI EC12 and IEC 60601-2-2Testing completed (results not explicitly detailed, but implied compliance).

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify the exact sample size for the test sets (e.g., number of EEG headcaps or subjects) used for each performance test. It only mentions that performance data was "provided" and "completed testing" was done.

    Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    This information is not applicable to this type of device and study. The Ceribell Instant EEG Headcap is a physical medical device (an electrode headcap), not an AI algorithm or diagnostic tool that requires expert interpretation for ground truth establishment. The performance criteria are objective measurements of electrical properties and biocompatibility.

    4. Adjudication Method for the Test Set

    This is not applicable as the tests performed are objective physical and electrical measurements, not interpretive clinical assessments requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. The Ceribell Instant EEG Headcap is a hardware device for signal acquisition.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This is not applicable. The device is a physical electrode headcap, not an algorithm. Its performance is measured through objective electrical and biocompatibility testing, not algorithmic accuracy.

    7. The Type of Ground Truth Used

    The "ground truth" for the tests performed on the Ceribell Instant EEG Headcap is based on established industry standards and objective measurable physical and electrical properties. For example:

    • Electrical Performance: The ground truth is defined by the limits set in ANSI/AAMI EC12.
    • Biocompatibility: The ground truth is defined by the pass/fail criteria of ISO 10993 tests (e.g., absence of cytotoxicity, sensitization, irritation).

    8. The Sample Size for the Training Set

    This is not applicable. The Ceribell Instant EEG Headcap is a physical medical device, not an AI model requiring a training set.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable for the same reason as above.

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