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510(k) Data Aggregation

    K Number
    K070623
    Device Name
    PHARMAPAC LUBRICATING JELLY
    Manufacturer
    PHARMAPAC LLC
    Date Cleared
    2007-08-31

    (178 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K810310
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

    Device Description

    PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

    AI/ML Overview

    The provided text describes a 510(k) submission for a personal lubricant device and does not contain information about acceptance criteria, device performance metrics, or a study that typically involves ground truth, experts, or comparative effectiveness for an AI/ML device. The "Performance Data" section solely refers to stability and microbial studies for the lubricant.

    Therefore, most of the requested information cannot be extracted from the given text.

    However, I can extract what little "performance data" is mentioned:

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    Shelf life stabilityConfirmed through 24 months
    Microbial conformanceIn accordance with USP standards

    Regarding the other requested information:

    • Sample sized used for the test set and the data provenance: Not applicable. The "performance data" concerns product stability and microbial testing, not a test set for an AI/ML device.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/ML device.
    • Adjudication method for the test set: Not applicable.
    • If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
    • The sample size for the training set: Not applicable. This is not an AI/ML device.
    • How the ground truth for the training set was established: Not applicable.
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