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510(k) Data Aggregation

    K Number
    K040914
    Device Name
    POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
    Manufacturer
    EXERO PRODUCTS, INC.
    Date Cleared
    2004-05-27

    (49 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K971618,K974281,K993486,K993487,K013232,K030987
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PolyVial / PolyPak Contact Lens Case storuge system by Exero Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lenses during chemical disinfection

    Device Description

    The Poly Vial / PolyPak by Exero Products consists of a polypropylene body, polypropylene cap, with an integrated Thermoplastic Elastomer (TPE) seal in the cap that provides a hermetically sealed container for leak proof storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lonses during chemical disinfection The storage system consists of two removable side-by-side Poly Vials that rest on a PolyPak that clearly identifies the left from the right. The PolyVials are closed by simply pressing the cap down onto the base that engages the Thermoplastic Elastomer integrated in the cap to the flange portion of the polypropylene base.

    AI/ML Overview

    This 510(k) summary describes a contact lens case, not a medical device in the typical sense of needing performance metrics like sensitivity, specificity, or image analysis. Therefore, many of the requested fields are not applicable.

    Here's an analysis based on the provided document:

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

    Acceptance Criteria (Stated Design Goal / Regulatory Standard)Reported Device Performance
    Overflow capacity of 3.2ml in each lens well (to ensure contact lens remains immersed)The PolyVial / PolyPak contact lens case is designed to have an overflow capacity of 3.2ml in each lens well. (Implies it meets this design goal)
    Non-cytotoxic (ISO 10993-5 Elution Test)The test article meets the requirements of the ANSI/AAMI/ISO Elution Test and was considered noncytotoxic.
    Non-cytotoxic (ISO 10993-5 / USP 27 Agar Diffusion)The test article meets the requirements of the USP and ISO Agarose Overlay Method test and was considered noncytotoxic.
    Non-toxic (USP Systemic Injection Toxicity)The lens material meets the requirements of the systemic injection test and is considered non-toxic.
    Non-irritating (ISO 10993-10 Acute Ocular Irritation Test)Acute ocular irritation test was performed and did not cause a positive irritation response to the eyes of the test animals.
    Hermetically sealed container for leak-proof storageConsists of a polypropylene body, polypropylene cap, with an integrated Thermoplastic Elastomer (TPE) seal in the cap that provides a hermetically sealed container for leak proof storage. (Implies this design feature is present and functional)

    2. Sample sized used for the test set and the data provenance

    The document does not explicitly state the sample sizes for the in-vitro and in-vivo tests. It refers to "series of in-vitro and in-vivo toxicological and chemical studies." The provenance is not explicitly stated as country of origin, but the studies were conducted "in compliance with Good Laboratory Practice Regulation for Nonclinical Laboratory Studies," implying they were conducted in a controlled, prospective manner.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This device is not an diagnostic imaging or AI device that requires expert ground truth for interpretation. The ground truth for the safety studies (cytotoxicity, toxicity, irritation) would be determined by laboratory assays and observations against established biological endpoints.

    4. Adjudication method for the test set

    Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic studies. Here, the results are derived from laboratory tests with clear pass/fail criteria.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This product is a physical contact lens case, not an AI-powered diagnostic device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This product is a physical contact lens case, not an algorithm.

    7. The type of ground truth used

    The ground truth used for performance validation was based on established regulatory and scientific standards for biocompatibility and safety testing, specifically:

    • ISO Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Acute Ocular Irritation).
    • USP Standards: USP 27 (Cytotoxicity), USP Systemic Injection Test.
    • Design Specifications: The self-declared design goal of 3.2ml overflow capacity.
    • Functional Design: The claim of a hermetically sealed container.

    8. The sample size for the training set

    Not applicable. This device does not use an AI algorithm that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable. This device does not use an AI algorithm that requires a training set.

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