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    K Number
    K221137
    Device Name
    Play and Joy Water-Based Lubricant
    Manufacturer
    InnoveMed Bio-tech Co., Ltd.
    Date Cleared
    2023-07-11

    (448 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K203654
    Why did this record match?
    Device Name :

    Play and Joy Water-Based Lubricant

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

    Play and Joy Water-Based Lubricant is a water-based personal lubricant, for penile 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. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

    Device Description

    Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device called "Play and Joy Water-Based Lubricant." It is a submission to the FDA demonstrating substantial equivalence to a predicate device.

    This document does not contain the type of acceptance criteria and study information (such as AI performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods) typically found for AI/ML-driven medical devices.

    The product described is a personal lubricant, and the performance testing focuses on its physical characteristics, biocompatibility, and condom compatibility, not on an AI algorithm's diagnostic performance. Therefore, I cannot extract the information requested in your prompt regarding AI device acceptance criteria and study data from this document.

    However, I can provide the acceptance criteria and performance data for the mechanical/physical performance of the lubricant as reported in the document:

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

    Physical SpecificationAcceptance Criteria (Specifications)Reported Device Performance
    AppearanceClear, semi-viscous liquidClear, semi-viscous liquid
    ColorColorlessColorless
    OdorOdorlessOdorless
    PH@25° C (per USP )4.92-5.384.92-5.38 (within range)
    Viscosity (cps, per USP )1727-3463 cps1727-3463 cps (within range)
    Specific Gravity (per USP )1.04-1.081.04-1.08 (within range)
    Osmolality (mOsm/Kg, per USP )(944-984) mOsm/kg(944-984) mOsm/kg (within range)
    Antimicrobial effectiveness (per USP )Category 2 product: bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 daysMet criteria (demonstrated antimicrobial effectiveness)
    Total yeast and mold count (TYMC, per USP ))
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