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510(k) Data Aggregation

    K Number
    K190864
    Device Name
    Konix Anti-Fog Solution
    Manufacturer
    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
    Date Cleared
    2020-08-27

    (512 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K932449
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.

    Device Description

    Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper.

    Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.

    The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.

    AI/ML Overview

    The provided text describes the Konix Anti-Fog Solution, a device intended to prevent fogging of endoscope and laparoscope lenses. The document is a 510(k) premarket notification summary submitted to the FDA. While it highlights safety and effectiveness, it does not include acceptance criteria or a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI/ML device.

    Instead, the performance data presented focuses on biocompatibility, sterilization validation, shelf-life, and a general "fog resistance test." The "acceptance criteria" for these tests are implied by "Pass" results against established standards.

    Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/Criteria CategoryAcceptance Criteria (Implied by Standards)Reported Device Performance
    BiocompatibilityMeet requirements of ISO 10993 series (Cytotoxicity, Sensitization, Intracutaneous Reactivity)All tests passed the requirements as indicated in the applicable standards.
    Cytotoxicity TestISO 10993-5:2009 standardsPass
    Sensitization TestISO 10993-10:2010 standardsPass
    Intracutaneous Reactivity TestISO 10993-10:2010 standardsPass
    Sterilization ValidationAchieve Sterility Assurance Level (SAL) < 10-6 according to ISO 11137-2, ISO 11737-1, ISO 11737-2Controlled at the dose of no less than 13.9 kGy, meeting SAL < 10-6.
    Shelf-Life (3 years accelerated aging)Maintain package integrity, seal strength, sterility, and product stability (fog resistance) according to ASTM F1980-16, ASTM F1929-15, ASTM F88/F88M-15, ISO 11737-2.All aging test data showed the product to be safe and effective for 3 years.
    Package Integrity TestASTM F1929-15 standardsPass
    Seal Peel Strength TestASTM F88/F88M-15 standardsPass
    Product Sterility TestISO 11737-2:2019 standardsPass
    Product Stability Studies (Fog Resistance Test)Internal testing protocol met (specific criteria not detailed)Pass (stated that "Konix Antifog Solution is effective" based on this test)

    Regarding the other requested information that is typically relevant for AI/ML devices, this document does not contain that information as it describes an anti-fog solution, not an AI/ML diagnostic device. Therefore, the following points cannot be answered from the provided text:

    1. Sample size used for the test set and the data provenance: Not applicable. The performance tests are laboratory-based for physical and biological properties.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. 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.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to meeting established physical, chemical, and biological safety and efficacy standards.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
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