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510(k) Data Aggregation

    K Number
    K113806
    Device Name
    KIMGUARD ONE STEP STERILIZATION WRAP
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Date Cleared
    2013-08-20

    (606 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K092167
    Predicate For
    K140963,K141612,K160755
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

    • Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 o
      • STERRAD® NX® [Standard Cycle, Advanced Cycle] o
      • STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o Cycle]

    KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

    Device Description

    KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously.

    The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

    AI/ML Overview

    The provided text describes the KIMGUARD® ONE-STEP® Sterilization Wrap and validation studies demonstrating its performance. However, it does not involve an AI device or a study comparing AI with human readers. Therefore, several sections of your request are not applicable.

    Here's the information that can be extracted from the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Maintain sterility until usedPassed: The nonclinical studies demonstrate that the KIMGUARD® ONE-STEP® Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the STERRAD® Sterilization Systems, and maintains sterility until used.
    Sterilant PenetrationPassed
    Package IntegrityPassed
    Maintenance of Package IntegrityPassed
    Material CompatibilityPassed
    Shelf LifePassed
    BiocompatibilityPassed
    Allow sterilization of enclosed devicesValidated: Test results validated that KIMGUARD® ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]). All models of the KIMGUARD® ONE-STEP® Sterilization Wrap have been validated for use with the specified STERRAD® cycles for various intended loads as detailed in Table 1 and Table 2 of the Indications for Use.

    Study Details

    1. Sample size used for the test set and the data provenance:

      • The document does not specify the exact sample sizes (e.g., number of wraps, number of sterilization cycles, number of instruments) used for the performance tests (Sterilant Penetration, Package Integrity, Maintenance of Package Integrity, Material Compatibility, Shelf Life, Biocompatibility).
      • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a performance study for a physical medical device (sterilization wrap), not an AI diagnostic device requiring expert ground truth establishment.

    3. Adjudication method for the test set: Not applicable. (See point 2)

    4. 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 device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through objective engineering and microbiological testing standards for sterilization wraps. This involves:

      • Verification of the ability to allow sterilant penetration.
      • Demonstration of package integrity (e.g., preventing microbial ingress).
      • Proof of material compatibility with sterilization methods.
      • Shelf life studies to ensure long-term integrity.
      • Biocompatibility testing to ensure safety of the material.
      • These are based on established scientific and regulatory guidelines for sterilization products.

    7. The sample size for the training set: Not applicable. This is not an AI model, so there is no training set.

    8. How the ground truth for the training set was established: Not applicable. (See point 7)

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