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510(k) Data Aggregation

    K Number
    K180247
    Device Name
    DAEHAN Adhesive Surface Electrodes
    Manufacturer
    Daehan Medical Systems Co., Ltd.
    Date Cleared
    2018-11-01

    (276 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K073532
    Why did this record match?
    Device Name :

    DAEHAN Adhesive Surface Electrodes

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

    The DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

    Device Description

    DAEHAN Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for DAEHAN Adhesive Surface Electrodes. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not directly available or applicable in this context for a novel device performance study.

    Instead, the submission focuses on comparing the new device to a predicate device based on technical characteristics and demonstrating that the new device meets relevant performance standards.

    Here's how to address your request based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    For a 510(k) of an adhesive surface electrode, acceptance criteria are typically defined by recognized consensus standards. The document states that the device was tested against these standards.

    Acceptance Criteria (Standard)SectionReported Device PerformanceComments
    Biocompatibility (Cytotoxicity)ISO 10993-5Met standardDevice evaluated for general biological safety.
    Biocompatibility (Irritation & Skin Sensitization)ISO 10993-10Met standardDevice evaluated for general biological safety.
    Electrical PropertyAAMI/ANSI EC12Met standardSpecific to "Disposable ECG Electrodes", implying electrical performance (e.g., impedance) requirements are met.
    Shelf-lifeASTM F1980-02Met standardEvaluates the accelerated aging of sterile medical device packaging (though the device itself is non-sterile).
    Electrical Safety (Patient Leads)AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3Conforms to standardConfirmed compliance with safety standards for patient leads.
    ImpedanceN/A (listed in comparison table)
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