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510(k) Data Aggregation

    K Number
    K100315
    Device Name
    12 LEAD GLOVE
    Manufacturer
    I NEEDMD, INC
    Date Cleared
    2010-04-23

    (78 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    I NEEDMD, INC

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

    The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

    Device Description

    The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter does not contain the specific information required to answer your questions regarding the acceptance criteria, study details, and performance of the "12 Lead Glove" device.

    The document is a clearance letter indicating that the device has been found substantially equivalent to a predicate device, allowing it to be legally marketed. It specifies the trade/device name, regulatory number, regulation name, regulatory class, product code, and the date of the 510(k) submission and review. It also includes the "Indications for Use" for the device, which states:

    "The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm."

    However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test sets or data provenance.
    3. Number of experts, their qualifications, or adjudication methods for ground truth.
    4. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
    5. Details on standalone algorithm performance.
    6. The type of ground truth used in studies.
    7. Sample size or ground truth establishment for the training set.

    To obtain this information, you would typically need to refer to the full 510(k) submission document, which would contain the clinical or non-clinical testing data that the FDA reviewed to make its substantial equivalence determination. This letter is merely the outcome of that review.

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