LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170138
    Device Name
    NEURONAUTE
    Manufacturer
    BIOSERENITY
    Date Cleared
    2017-12-26

    (343 days)

    Product Code
    GWQ,GXY
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K061148,K131383
    Why did this record match?
    Reference Devices :

    K061148

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

    The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.

    It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.

    The Neuronaute requires operation by a trained healthcare professional.

    The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

    Device Description

    The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).

    The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.

    The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.

    The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting study for the Neuronaute device, based on the provided FDA 510(k) summary:

    The Neuronaute device is an electroencephalograph (EEG) system intended for acquiring, recording, storing, transmitting, and displaying EEG from adult patients. The acceptance criteria and supporting studies focus on demonstrating that the Neuronaute performs similarly to or better than predicate devices, and meets relevant electrical, software, and biocompatibility standards.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly list "acceptance criteria" with numerical targets and then "reported device performance" in a separate section. Instead, the "Performance Data" and "Technological Characteristics" sections describe testing conducted and the device's measured specifications, often compared directly to predicate devices to demonstrate substantial equivalence. I will synthesize the relevant information into a table, focusing on direct and inferable criteria for signal quality and electrical characteristics.

    Acceptance Criteria (Inferred from Predicate Equivalence & Standards)Neuronaute Reported Performance
    Electrical Performance:
    Sampling rate500 s/s (vs. predicate 256 s/s)
    Dynamic range+/- 600mV (vs. predicate +/- 1000 µV - note: units differ, but generally implies a range adequate for EEG)
    Noise
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1