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510(k) Data Aggregation

    K Number
    K012309
    Device Name
    RIWO SYSTEM TRAYS
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2001-10-19

    (88 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RIWO System Trays 38201.xxx, 38202.xxx, 38301.xxx have been designed to hold devices during sterile storage, transport, and while undergoing steam and ethylene oxide sterilization.

    Device Description

    The devices are assorted open or closed trays for sterilization, storage and transport. The RIWO System Trays are blue in color. The assorted trays vary in size and begin with product number 3820x.xxx. Other characteristics are a base, latched cover and silicone peg mat construction. These trays hold the device to be sterilized and the tray must be wrapped for sterilization and sterile storage. They can be used in steam or ethylene oxide sterilization.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

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

    Acceptance Criteria (Implied)Reported Device Performance
    Functional Performance after Steam SterilizationThe steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the pre-vac method. (This implies that the functional performance after steam sterilization was maintained to an acceptable degree.)
    Functional Performance after Ethylene Oxide (EO) SterilizationThe EO sterilization tests performed, shows that the ethylene oxide sterilization has no influence on the functional performance of the submitted devices. (This implies that the functional performance after EO sterilization was maintained to an acceptable degree.)
    Safety and Effectiveness"These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the conclusion, implying that the device met internal safety and effectiveness standards, likely encompassing functional performance after sterilization, material compatibility, and structural integrity for holding and transporting instruments without damage.)

    Note: The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "no visible deformation," "maintains structural integrity for X cycles"). The reported performance is qualitative, stating "no influence on functional performance."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: Not explicitly stated. The document refers to "the submitted devices" but does not quantify how many trays of each type/model were tested, or how many sterilization cycles each tray underwent.
    • Data Provenance: The tests were "performed by Richard Wolf," meaning they were internal company tests. The country of origin for the testing is not explicitly stated, but since the submitter is based in Illinois, USA, it is likely the tests were conducted there or at a facility managed by Richard Wolf. The tests were prospective, conducted specifically to support the 510(k) submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. This device is a medical accessory (trays for sterilization, storage, and transport), not an AI/diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance would be its physical integrity and functionality after sterilization cycles, as determined by engineering/quality assurance personnel.

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

    • Not applicable. As this is not an AI/diagnostic device, there was no need for expert adjudication of results. The performance testing would be objectively measured/observed based on established protocols.

    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

    • No. This is not an AI-assisted diagnostic device.

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

    • No. This is not an algorithm or AI device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not applicable in the typical sense for AI/diagnostic devices. For this device, the "ground truth" for its performance would be the direct observation and measurement of its physical properties and functional integrity (e.g., lack of deformation, continued ability to hold instruments, proper latching of covers) after undergoing sterilization cycles according to specified parameters. This is engineering/performance ground truth, not clinical ground truth.

    8. The sample size for the training set

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

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

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