LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091554
    Device Name
    PHARMAPAC PERSONAL LUBRICANT
    Manufacturer
    PHARMAPAC LLC
    Date Cleared
    2009-08-07

    (72 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K955648
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lubricating 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, polyisoprene, and polyurethane condoms.

    Device Description

    PharmaPac Personal Lubricant is a water-based personal lubricant formulated to be a non-greasy, non-sticky, non-staining clear gel-like liquid. The water-soluble formula allows this product to be rinsed off with water.

    AI/ML Overview

    The provided text is a 510(k) summary for the PharmaPac Personal Lubricant. It documents the submission for FDA clearance of a medical device, in this case, a personal lubricant. The content of this document does not contain the specific type of performance data and study details requested in the prompt, as it is a summary for a device that is substantially equivalent to a predicate device, and thus relies on the predicate's established performance rather than extensive new clinical studies.

    Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.

    The "Performance Data" section specifically states:
    "Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards."

    This indicates a stability study was performed, which is a chemical/physical performance test, not a study involving human subjects or expert review for diagnostic accuracy. This type of device (personal lubricant) does not typically require the kinds of studies (e.g., MRMC, standalone algorithm performance, expert consensus on images) that would involve the criteria you've outlined, as it's not an AI/imaging diagnostic device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1