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510(k) Data Aggregation

    K Number
    K093156
    Device Name
    PRUCLAIR NONSTEROIDAL CREAM
    Manufacturer
    PRUGEN IP HOLDINGS, INC
    Date Cleared
    2010-06-24

    (261 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K024367
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
    PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.

    Device Description

    PruClair™ non-steroidal cream is a non-sterile, viscous emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.

    AI/ML Overview

    The provided K093156 510(k) summary for "PruClair™ non-steroidal cream" does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or MRMC studies) typically associated with an AI/ML device.

    This document describes a drug/biologic product (a cream), not an AI/ML powered medical device. The "functional testing" mentioned is likely related to the chemical and physical properties of the cream, its stability, safety (e.g., irritation studies), and possibly its efficacy in a clinical setting as a topical treatment for dermatoses, minor burns, cuts, lacerations, and irritations.

    Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving device performance as they would apply to an AI/ML device. The information you are asking for is not present in this type of submission for a non-AI/ML product.

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