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510(k) Data Aggregation

    K Number
    K213170
    Device Name
    SENSOSEEG Depth Electrodes
    Manufacturer
    Sensomedical Labs LTD
    Date Cleared
    2023-04-18

    (567 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K170959,K964644,K802152
    Why did this record match?
    Device Name :

    SENSOSEEG Depth Electrodes

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

    Senso Medical Depth Electrodes are intended for temporary (

    Device Description

    The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.

    AI/ML Overview

    This FDA 510(k) summary provides information on the SENSOSEEG Depth Electrodes. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the typical format of a diagnostic algorithm's performance study.

    This document is a premarket notification for a medical device (depth electrodes), not a diagnostic algorithm. Therefore, the "acceptance criteria" and "study" described are focused on the device's physical and functional properties, and its substantial equivalence to predicate devices, rather than on diagnostic performance metrics like accuracy, sensitivity, or specificity common to AI/ML software.

    The acceptance criteria are implied by the comparison to predicate devices and the non-clinical testing performed.

    Here's an attempt to categorize the information based on your request, keeping in mind the nature of this submission:

    1. A table of acceptance criteria and the reported device performance

    Since this is a physical medical device (depth electrodes), the "acceptance criteria" are related to its design specifications, material properties, and functional performance, rather than diagnostic accuracy. The "reported device performance" is largely demonstrated by showing equivalence to legally marketed predicate devices through bench testing and material comparison.

    Acceptance Criterion (Implied)Reported Device Performance (as demonstrated by comparison and testing)
    Intended Use (Temporary recording, monitoring, stimulation of electrical brain signals)Identical to all predicate devices (DIXI Medical Microdeep Depth Electrode (K170959), Ad-tech depth electrodes (K964644), PMT Depthalon Electrodes (K802152)).
    Clinical Application (Placement in subsurface brain for recording, monitoring, stimulation)Identical to DIXI Medical and Ad-tech depth electrodes.
    Contraindications (Patients at risk for infection or unsafe surgical procedures)Identical to Ad-tech depth electrodes.
    Single-patient use, DisposableIdentical to all predicate devices.
    Provided SterileIdentical to all predicate devices; EO Sterilization validated.
    Environment of Use (Intraoperative and Neurological monitoring locations)Identical to all predicate devices.
    Duration of Use (
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