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510(k) Data Aggregation

    K Number
    K242406
    Device Name
    SiOxC Cream
    Manufacturer
    SiOxMed, LLC
    Date Cleared
    2025-03-13

    (211 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K241660,K052643
    Why did this record match?
    Reference Devices :

    K241660

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.

    Device Description

    SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "SiOxC Cream". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

    Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a topical cream, primarily through:

    • Comparison of technological characteristics: This involves comparing the composition, principle of operation, preservative, available offerings, reapplication frequency, sterility, and biocompatibility of the SiOxC Cream with a predicate device (EPICERAM® Skin Barrier Emulsion).
    • Non-clinical performance testing: This includes characterization of pH, viscosity, macroscopic and microscopic appearance, and preservative effectiveness testing (USP ) to support shelf-life.
    • Biocompatibility testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23.
    • Human Repeat Insult Patch Test (HRIPT): This study assessed the potential for dermal irritation and sensitization.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to an AI/ML medical device, because the provided text is for a topical cream and lacks any mention of AI/ML or corresponding performance metrics.

    The text states that SiOxC Cream is a "skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment." and that it is "unclassified". This is a non-AI/ML product review.

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