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510(k) Data Aggregation

    K Number
    K094039
    Device Name
    HYALO GYN
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Date Cleared
    2010-05-07

    (128 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K072647
    Why did this record match?
    Device Name :

    HYALO GYN

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

    HYALO GYN is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.

    Device Description

    HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process. HYALO GYN is intended for use as a personal lubricant. HYALO GYN is compatible with latex condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and a shelf life of 3 years.

    HYALO GYN acts as a moisturizer and lubricant because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol, combined with the hyaluronic acid derivative, enable HYALO GYN to achieve its thick, viscous gel form, and the mucoadhesive properties of the product allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating and protecting this tissue.

    AI/ML Overview

    The provided document is a 510(k) summary for the device HYALO GYN®, a vaginal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.

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

    The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for all performance aspects. Instead, it describes studies and their outcomes to support safety and effectiveness. Based on the information provided, the following table summarizes the performance data and the implied criteria met:

    Performance AspectImplied Acceptance Criteria (Based on Study Outcome)Reported Device Performance
    Biocompatibility
    CytotoxicityNot cytotoxicCytotoxicity studies demonstrate that HYALO GYN is not cytotoxic.
    Acute Intraperitoneal ToxicityLethal dose >10 ml/kgAn acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal dose is >10 ml/kg but
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