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510(k) Data Aggregation

    K Number
    K180219
    Device Name
    JO H2O Flavored Personal Lubricants
    Manufacturer
    United Consortium
    Date Cleared
    2018-04-20

    (85 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K140590
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

    Device Description

    JO H2O Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

    These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in polyester-faced laminated pouches.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA regarding "JO H2O Flavored Personal Lubricants." This document describes the device, its intended use, comparison to a predicate device, and performance data from various tests. However, it does not pertain to an AI/ML-enabled medical device or a study involving human readers and AI assistance. Therefore, I am unable to extract the specific information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML context.

    The document discusses acceptance criteria and studies for a personal lubricant, focusing on:

    • Biocompatibility: Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity, and Sensitization.
    • Shelf-Life: Real-time aging study testing device specifications at 0, 1, 2, and 3 years.
    • Condom Compatibility: Evaluation with different condom materials (natural rubber latex, polyisoprene, polyurethane) in accordance with ASTM D7661-10.

    Without information specific to an AI/ML medical device, I cannot fulfill the request as formatted.

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