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510(k) Data Aggregation

    K Number
    K021125
    Device Name
    SENSUA!
    Manufacturer
    AAC CONSULTING GROUP, INC.
    Date Cleared
    2002-10-25

    (200 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K983216,K935299,K001077
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

    Device Description

    SENSUA! is a clear, colorless personal lubricant composed of: purified water. Propylene glycol, L-arginine, Hydroxyethyl cellulose, Methylparaben and other ingredients.

    AI/ML Overview

    This document is a 510(k) summary for a personal lubricant called "SENSUA! Personal Lubricant". It is not a study about a medical device that utilizes an algorithm or AI. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

    The document discusses the device's general information, predicate devices, description, and intended use as a moisturizer for vaginal dryness and personal lubrication. It also confirms that the device has been tested for condom compatibility and preservative effectiveness to demonstrate substantial equivalence to predicate devices. However, no specific performance metrics or studies are detailed in relation to these tests.

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