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510(k) Data Aggregation

    K Number
    K171102
    Device Name
    Ives MR Conditional Cup Electrode
    Manufacturer
    Ives EGG Solutions
    Date Cleared
    2017-12-21

    (252 days)

    Product Code
    GXY
    Regulation Number
    882.1320
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    Applicant Name (Manufacturer) :

    Ives EGG Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording. The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning. The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.
    Device Description
    The cutaneous surface electrode (CPE) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, conductive plastic and Ag-Ag/Cl, materials that have long been used for this intended purpose throughout the industry and compatible to the MR environment. The conductive cup electrode is permanently connected to a PVC insulated copper lead wire varying in length from 6" to 9". This joint is then covered in a heatshrink tube to provide a strain relief. The lead wires are staggered in length (6" to 9") and terminate in a small mass connector that conforms to DIN 42-802 for electrical safety. A blue sponge is provided to locate the lead wire termination off of the scalp and at the top of the patient's head. To permit EEG monitoring, this small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802. The Harness is disconnected for imaging. The electrode lead length is as short as possible to connect directly with the 10-20 EEG scalp site. This prevents coiling of the lead wires and as short as possible lead length to reduce or eliminate the RF heating antenna effect during MR scanning sequences. Electrode and lead materials are selected to avoid use of any magnetic ferrous metals.
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