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510(k) Data Aggregation

    K Number
    K062873
    Device Name
    SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
    Manufacturer
    E.C.I. USA CORPORATION
    Date Cleared
    2007-03-20

    (176 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032325
    Why did this record match?
    Applicant Name (Manufacturer) :

    E.C.I. USA CORPORATION

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

    Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

    Device Description

    The SunPolar Netex Medical Stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

    AI/ML Overview

    The provided text is a 510(k) summary for the SunPolar Netex Medical Stockings, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, study methodology, or results as requested.

    The document indicates that the SunPolar Netex Medical Stockings are substantially equivalent to a predicate product (Jobst Travel Sock K032325) based on materials, mode of action, and indications for use. The acceptance criteria for substantial equivalence in a 510(k) submission are not performance metrics of the device but rather a demonstration that the new device is as safe and effective as a legally marketed predicate device.

    Therefore, I cannot populate the table or answer most of the questions as the provided document does not contain information about a study that would establish specific acceptance criteria and demonstrate the device's performance against them.

    Here's why each specific point cannot be answered from the provided text:

    1. Table of acceptance criteria and reported device performance: Not available. The 510(k) process for this device relies on substantial equivalence to a predicate, not on a full performance study with acceptance criteria.
    2. Sample size, data provenance, retrospective/prospective: No study details are provided.
    3. Number of experts and qualifications for ground truth: Not applicable, as there's no study with a ground truth established by experts mentioned.
    4. Adjudication method: Not applicable.
    5. MRMC comparative effectiveness study, effect size: Not applicable. This type of study is more common for diagnostic imaging AI.
    6. Standalone performance study: Not mentioned.
    7. Type of ground truth used: Not applicable.
    8. Sample size for training set: Not applicable, as this is not a report on a machine learning model's development.
    9. How ground truth for training set was established: Not applicable.
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