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510(k) Data Aggregation

    K Number
    K213900
    Device Name
    WAVi SCAN EEG System and Accessories
    Manufacturer
    WAVi Co.
    Date Cleared
    2022-05-06

    (143 days)

    Product Code
    GWQ,GWJ,OLT
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K162460,K171781,K143233,K141316
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    Device Name :

    WAVi SCAN EEG System and Accessories

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

    WAV SCAN EEG System is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

    Device Description

    WAVi™ SCAN EEG system (WAVi™ SCAN 1.0) is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming. The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone.

    AI/ML Overview

    The WAVi Scan EEG System has acceptance criteria primarily related to its electrical performance and adherence to established medical device standards. The study presented is a pre-market notification (510(k)) submission to the FDA, which demonstrates substantial equivalence to predicate devices rather than a comparative effectiveness study in the traditional sense of human reader improvement.

    Here's a breakdown of the acceptance criteria and the study's proof of meeting them:

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria are derived from recognized international standards for electroencephalographs, particularly IEC 80601-2-26:2019, and general electrical safety and electromagnetic compatibility (EMC) standards. The study demonstrates conformance to these standards.

    Acceptance Criteria (from IEC 80601-2-26:2019)Reported Device Performance (Results)
    Accuracy of signal reproduction: Input voltages in specified ranges reproduced with error ≤ ±20% of nominal output or ±10 µV, whichever is greater.P (Pass)
    Input dynamic range and differential offset voltage: With ±150mV DC offset and ±0.5mV varying input, output amplitude change ≤ ±10% over specified range.P (Pass)
    Input noise: Signal noise caused by amplifier and patient cable ≤ 6 µV peak-to-valley referred to input (RTI).P (Pass) - Device noise reported as
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