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510(k) Data Aggregation

    K Number
    K113340
    Device Name
    KIMBERLY-CLARK CHILD'S FACEMASK
    Manufacturer
    KIMBERLY-CLARK
    Date Cleared
    2012-05-04

    (172 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K103150
    Why did this record match?
    Device Name :

    KIMBERLY-CLARK CHILD'S FACEMASK

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

    The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

    Device Description

    The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.

    AI/ML Overview

    This K113340 submission is for a Kimberly-Clark Pediatric/Child Facemask, which is a physical device, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment) are not applicable.

    However, I can provide information based on the provided text regarding the acceptance criteria and study that proves the device meets the acceptance criteria for this specific medical device submission, focusing on the material characteristics and performance relevant to a face mask.

    Here's the breakdown of the available information:

    Acceptance Criteria and Reported Device Performance

    The device, a Kimberly-Clark Pediatric/Child Facemask, was tested against various standards. The summary states that "All results of testing met acceptance criteria." Specific numerical acceptance criteria are not detailed in the provided text, but the standards themselves imply the criteria.

    Acceptance Criteria (Implied by Standard)Reported Device Performance (as stated in the summary)
    Mil-M369454C (Military Specifications: Surgical Mask, disposable 1992) - Specific criteria not detailed in the provided text.Met acceptance criteria
    PSC CS-191-53 (Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles) - Specific criteria not detailed.Met acceptance criteria
    ASTM F 2299 (Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres) - Specific efficiency thresholds not detailed.Met acceptance criteria
    ASTM 2101-07 (Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials. Using a Biological Aerosol of Staphylococcus aureus) - Specific BFE thresholds not detailed.Met acceptance criteria
    ISO 10993 (Standards for evaluating the biocompatibility of a medical device) - Specific biocompatibility assessment results not detailed.Met acceptance criteria

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

    • Sample Size for Test Set: The document does not specify the sample size (e.g., number of masks, number of material swatches) used for each of the tests.
    • Data Provenance: Not explicitly stated, but the tests were performed by Kimberly-Clark as part of their 510(k) submission. This is prospective testing conducted specifically for this regulatory submission. There is no information about country of origin for the data.

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

    Not applicable. This is a physical device subject to performance testing against established engineering and medical standards, not diagnostic or interpretive tasks requiring expert ground truth for a test set in the same sense as an AI/ML medical device. The "ground truth" would be the objective results of the validated test methods.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. This concept applies to human interpretation of data for ground truth establishment, not to objective physical product testing.

    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/ML device, nor does it involve human readers/interpreters.

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

    Not applicable. This is not an algorithm or AI system.

    7. The type of ground truth used

    The "ground truth" for this device's performance is established by the results of standardized physical, chemical, and biological tests (e.g., flammability, particulate filtration efficiency, bacterial filtration efficiency, biocompatibility) against the pre-defined criteria within the referenced standards (Mil-M369454C, PSC CS-191-53, ASTM F 2299, ASTM 2101-07, ISO 10993).

    8. The sample size for the training set

    Not applicable. This is not an AI/ML device that requires a training set.

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

    Not applicable. This is not an AI/ML device.

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