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510(k) Data Aggregation

    K Number
    K213598
    Device Name
    LUOFUCON Collagen Wound Dressing
    Manufacturer
    Huizhou Foryou Medical Devices CO., Ltd.
    Date Cleared
    2022-09-20

    (309 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K102946,K060456
    Why did this record match?
    Reference Devices :

    K102946

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

    LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.

    The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

    Device Description

    LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.

    When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.

    LUOFUCON® Collagen Wound Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

    LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

    AI/ML Overview

    The provided text is a 510(k) summary for the LUOFUCON® Collagen Wound Dressing, which is a medical device intended for wound management. The document states that the device is substantially equivalent to a predicate device (Medline Collagen Wound Dressing, K060456).

    The document does not describe a study in the context of comparing the device to human readers or an AI algorithm, but rather a set of bench tests and biocompatibility tests to demonstrate safety and effectiveness for its intended use, and to prove substantial equivalence to a predicate device. This is typical for a 510(k) submission for a wound dressing, which is not an AI-powered diagnostic device.

    Therefore, many of the requested fields are not applicable to the information provided in this document.

    Here's a breakdown based on the available information:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics. Instead, it states that "the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

    However, we can infer some "performance requirements" that were tested:

    CriterionReported Device Performance
    SterilizationSterilized using gamma radiation to a sterility assurance level of 10^-6. Confirmed per ISO 11137-1/-2.
    Shelf-Life2 years (demonstrated by real-time aging test).
    BiocompatibilityMeets biocompatibility requirements of ISO 10993-1 standard and FDA Guidance; raised no new safety concerns.
    Physical/Chemical/Biological Properties (Bench Tests)Meets all product performance requirements for the intended use; demonstrates substantial equivalence to the predicate device.
    Animal-Derived Materials SafetyCompliant with FDA guidance and ISO 22442 standards; more than 6 logs reduction of viruses.

    2. Sample size used for the test set and the data provenance

    Not applicable in the context of an AI/human reader study. The document refers to "non-clinical data and performance data" and "bench tests" performed on the device itself. Specific sample sizes for these tests (e.g., number of dressings tested for tensile strength) are not provided in this summary.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. There is no mention of a test set with ground truth established by experts, as this is not an AI diagnostic device.

    4. Adjudication method for the test set

    Not applicable.

    5. 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-powered device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is not an AI-powered device.

    7. The type of ground truth used

    Not applicable. The "ground truth" here is the physical, chemical, biological, and safety characteristics of the device being evaluated against established standards and the characteristics of the predicate device. For example, for sterility, the ground truth is "sterile at SAL 10^-6". For biocompatibility, the ground truth is "meeting ISO 10993-1 requirements".

    8. The sample size for the training set

    Not applicable. There is no "training set" in the context of a machine learning model for this medical device submission.

    9. How the ground truth for the training set was established

    Not applicable.

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