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510(k) Data Aggregation

    K Number
    K072741
    Device Name
    PRE-VA VAGINAL LUBRICANT
    Manufacturer
    INGFERTILITY, LLC
    Date Cleared
    2008-07-16

    (293 days)

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

    PRE-VA VAGINAL LUBRICANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions.
    • As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.
    Device Description

    This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms.

    AI/ML Overview

    This document is a 510(k) summary for the Pre~Va Vaginal Lubricant. It states that the device is substantially equivalent to a predicate device, and as such, it does not present acceptance criteria or a study proving that the device meets those criteria.

    The 510(k) summary explicitly states:
    "All of the technological characteristics of PreVa are identical to the predicate device."
    "The performance data of Pre    Va are identical to the predicate."
    "Pre~Va Vaginal Lubricant is safe for its intended use and substantially equivalent to the predicate device Pre' Vaginal Lubricant."

    Therefore, the requested information regarding acceptance criteria and performance studies is not available in this document because the device's approval is based on its substantial equivalence to a previously approved predicate device, not on a new performance study against specific acceptance criteria.

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