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510(k) Data Aggregation

    K Number
    K071203
    Device Name
    SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
    Manufacturer
    OPTIKEM INTERNATIONAL, INC.
    Date Cleared
    2007-06-13

    (43 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K011561
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIKEM INTERNATIONAL, INC.

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

    The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear.

    Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

    Device Description

    Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses.

    Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a soft contact lens cleaning solution. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI-specific metrics are not applicable.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical performance data to support the safety and effectiveness of the Sereine Extra Strength Daily Cleaner.

    However, I can extract the information that is available regarding the performance of the device and the studies conducted:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (What was tested for)Reported Device Performance
    30-day Silicone Hydrogel Compatibility
    Parameter Change (15 days)No Change (for all tested lens types)
    Parameter Change (30 days)No Change (for all tested lens types)
    Color ChangeNo Change (for all tested lens types)
    Cytotoxicity (after 30-day cleaning)Lenses met ISO requirements for Cytotoxicity.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: Not explicitly stated as a numerical sample size. The compatibility study tested "Four Silicone Hydrogel contact lens types," namely: senofilcon A (Oasys), lotrafilcon A (Night & Day), comfilcon A (Biofinity), and balafilcon A (Purevision). For cytotoxicity, it refers to "the four Silicone Hydrogel lenses" cleaned over 30 days.
    • Data Provenance: The studies appear to be pre-clinical, conducted by the applicant or a contract research organization in support of the 510(k) submission. No information on country of origin of data or whether it was retrospective/prospective is provided.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    • This information is not applicable. The studies referenced are laboratory-based compatibility and cytotoxicity tests, not expert-adjudicated clinical studies for AI/ML performance. The "ground truth" here is determined by objective physical and biological measurements against established standards (e.g., ISO standard 81369-2 for lens parameters, ISO requirements for Cytotoxicity).

    4. Adjudication Method for the Test Set:

    • This information is not applicable. There was no human adjudication process described, as the tests involved objective measurements.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

    • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a contact lens cleaning solution.

    6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:

    • This information is not applicable. The device is a physical cleaning solution, not an AI algorithm.

    7. The Type of Ground Truth Used:

    • For compatibility: Objective measurements of lens parameters and visual inspection for discoloration/clarity changes, compared against a baseline and established ISO standards (ISO standard 81369-2).
    • For cytotoxicity: Laboratory assessment of cytotoxicity, meeting "ISO requirements."

    8. The Sample Size for the Training Set:

    • This information is not applicable. The device is not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established:

    • This information is not applicable. There is no training set for this type of medical device submission.
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