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510(k) Data Aggregation

    K Number
    K042578
    Manufacturer
    Date Cleared
    2005-01-25

    (125 days)

    Product Code
    Regulation Number
    886.5928
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    I-PROMOTIONS, INC.

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

    For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only, Not to be used with heat.

    Device Description

    The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.

    AI/ML Overview

    This document describes the regulatory submission for the "i-Promotions Contact Lens Case" and does not contain information about the acceptance criteria or a study that proves a device meets such criteria in the context of advanced medical technologies or AI/ML.

    The provided text focuses on the device's classification, intended use, and summary of safety testing carried out for regulatory clearance. It benchmarks the device against predicate devices based on design and materials, rather than performance metrics.

    Therefore, I cannot provide the information requested in your bullet points (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details) because the document does not discuss these aspects in the context of device performance or clinical studies. The "Summary of Safety Testing" section only mentions cytotoxicity testing to demonstrate the product is safe for its intended use, but doesn't provide specific performance acceptance criteria or detailed study results beyond a general statement of safety.

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