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510(k) Data Aggregation

    K Number
    K231366
    Device Name
    Neuronaute Plus
    Manufacturer
    BioSerenity SAS
    Date Cleared
    2023-11-09

    (182 days)

    Product Code
    GWQ, GXY
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BioSerenity SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the BioSerenity Cloud. The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver. Adequate training is recommended for proper use of the device. Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording. The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.
    Device Description
    The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders. The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi. - -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system. - -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small. - -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap. - -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional. - -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel. - Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus. - Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions. - -Bioserenity CLOUD: is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud. - -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.
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    K Number
    K202334
    Device Name
    Neuronaute
    Manufacturer
    Bioserenity SAS
    Date Cleared
    2020-12-10

    (115 days)

    Product Code
    GWQ, GWO
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioserenity SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.
    Device Description
    Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: Neuronaute Head Module, Neuronaute High Capacity Battery Module, Neuronaute BioAdapter, Neuronaute Mobile App, Neuronaute N-CLOUD, Neuronaute N-DEO, Neuronaute N-WAY, Neuronaute IceCap.
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    K Number
    K173248
    Device Name
    CARDIOSKIN
    Manufacturer
    Bioserenity SAS
    Date Cleared
    2018-08-11

    (305 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioserenity SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.
    Device Description
    Cardioskin is a wireless and wearable medical device. It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only. Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder. Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App. A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.
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