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510(k) Data Aggregation

    K Number
    K160763
    Device Name
    ally Liquid Personal Lubricant
    Manufacturer
    GUY & O'NEILL, INC.
    Date Cleared
    2016-06-29

    (100 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K141581
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ally® Liquid 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

    Device Description

    ally® Liquid Personal Lubricant is a non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamper-proof seals.

    INGREDIANTS: Purified water, propanediol, hydroxyethylcellulose, hydroxyacetophenone, lactic acid

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant (ally® Liquid Personal Lubricant). It is not a study proving device acceptance. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data for a new medical device technology like AI.

    Therefore, I cannot provide the requested information as the document does not contain:

    • A table of acceptance criteria and reported device performance in the context of a new device's efficacy study.
    • Details on sample sizes, data provenance, ground truth establishment methods, or expert qualifications for a test set.
    • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    The document primarily states that the device was found substantially equivalent to a legally marketed predicate device (Astroglide® Natural Liquid Personal Lubricant, K141581) based on meeting recognized consensus standards for biocompatibility, microbiology, condom compatibility, and shelf-life testing. These are regulatory compliance aspects, not detailed performance studies in the way you've outlined for AI or other complex medical devices.

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