LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K200416
    Device Name
    Boston One Step Liquid Enzymatic Cleaner
    Manufacturer
    Bausch & Lomb Incorporated
    Date Cleared
    2020-09-23

    (216 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K181627
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.

    Device Description

    Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a contact lens care product, the "Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner." The submission seeks to add an alternative manufacturing site and change packaging resin and raw material suppliers.

    However, the document does not contain information about acceptance criteria for a device's performance based on AI/algorithm/software output, nor does it detail a study proving the device meets such criteria. The "Preclinical testing" mentioned is related to biocompatibility and confirms the safety and effectiveness of the product itself, not a software device.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information (specifically points 1-9 regarding an AI/algorithm-based device and its validation) is absent from the provided text.

    The text focuses on the following:

    • Device Type: A contact lens care solution (not an AI/software device).
    • Purpose of 510(k) Submission: To add an alternative manufacturing site and modify packaging components, not to introduce or validate a new AI/software feature or performance.
    • Testing Mentioned: Biocompatibility, cytotoxicity, and ocular irritation studies related to the chemical solution and its packaging components. These are standard tests for medical devices that come into contact with human tissue, not for evaluating AI performance metrics like sensitivity, specificity, or reader improvement.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1