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510(k) Data Aggregation

    K Number
    K110985
    Device Name
    ICON ADULT MANUAL
    Manufacturer
    ICON WHEELCHAIRS INC
    Date Cleared
    2011-05-03

    (25 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K082970
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICON WHEELCHAIRS INC

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

    The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide mobility to persons with disabilities restricted to a seated position.

    Device Description

    The Icon Adult Manual Wheelchair is a rigid manual wheelchair, with a centralized modular design. The frame components of the chair are aluminum.

    AI/ML Overview

    The provided text is a 510(k) summary for a manual wheelchair, not a medical device driven by an algorithm or AI. Therefore, it does not contain the information required to answer your specific questions related to AI-driven device acceptance criteria and study design.

    However, I can extract the acceptance criteria and performance information that is present in the document for this physical device.

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

    For the Icon Adult Manual Wheelchair, the "acceptance criteria" are implied by the standards it references, and the reported performance is simply that the results were "as expected" with "no pass/fail criteria" explicitly stated in the summary.

    CharacteristicStandard/Test/FDA GuidanceReported Device Performance
    Static StabilityANSI/RESNA WC/Volume 1-1998, Section 1: Determination of Static StabilityResults were as expected
    Overall dimensions, mass and manoeuvring spaceANSI/RESNA WC/Volume 1-1998, Section 5: Determination of overall dimensions, mass and manoeuvring spaceResults were as expected
    Static, Impact & Fatigue StrengthANSI/RESNA WC/Volume 1-1998, Section 8: Requirements and Test Methods for Static, Impact and Fatigue StrengthsResults were as expected
    Resistance to IgnitionANSI/RESNA WC/Volume 1-1998, Section 16: Resistance to Ignition of Upholstered PartsResults were as expected

    Regarding the other questions (2-9), these are specifically geared towards AI/algorithmic devices and are not applicable to the Icon Adult Manual Wheelchair, which is a physical mechanical device.

    The document states:

    • "There is no pass/fail criteria for this test – results were as expected."
    • The tests are "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE". These tests are designed to show that the new device performs similarly to a predicate device based on established standards for mechanical wheelchairs, rather than meeting specific performance metrics derived from a data-driven model.
    • The device is a "mechanical wheelchair," not an AI product.
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