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510(k) Data Aggregation

    K Number
    K033222
    Date Cleared
    2004-08-02

    (304 days)

    Product Code
    Regulation Number
    880.6850
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    OLYMPUS STERILIZATION TRAYS

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

    The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device.

    The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm.

    The Olympus sterilization trays are to be sterilized in the following cycle:

    Prevacuum Steam: 132°C - 134°C - 5 minutes minimum.
    Drying Time: 10 – 20 minutes as needed.

    Device Description

    The Sterilization trays, which are the subject of this premarket notification, are as follows:

    Item no.Outer dimensions WxHxD[mm]Detailed product description
    A5938*595 x 61 x 295Instrument tray, with lid, for video telescope
    A5951*478 x 41 x 224Insert tray, for 2.7 and 4.0 mm TruView arthroscopes
    A5952*478 x 41 x 224Insert tray, for Diver-Line hand instruments
    A5961*665 x 52 x 204Insert tray, for ureteroscopes, with lid
    A5975*532 x 63 x 128Instrument tray, small, with lid
    A5976*478 x 68 x 224Insert tray, for urology
    A5977*478 x 68 x 224Insert tray, for 4 TroQ trocars
    A5984*Set: A5994 and WA05974Instrument tray, for camera head and adapter
    A5992*478 x 54 x 224Instrument tray, for A3336A, A2027A and A5226A
    A5994*478 x 68 x 224Insert tray, for camera head and adapter
    A05951A*478 x 41 x 224Insert tray, for TrueView II and mini TrueView telescopes
    A05952A*665 x 65 x 204Instrument tray, for SonoSurg instruments, with lid
    A05961A*405 x 95 x 200Instrument tray, for compact cystoscope and compact hysteroscope, with lid
    WA05970A537 x 139 x 268Instrument tray, with lid and silicone mat
    WA05971A482 x 60 x 224Insert tray, for the upper part of WA05970A, with silicone mat
    WA05972A480 x 47 x 224Insert tray, for 5 HiQ shafts and jaw inserts
    WA05973A460 x 39 x 207Insert tray, for the bottom of WA05970A, with silicone mat
    WA05974A488 x 31 x 235Lid, for insert trays
    WA05980A438 x 176Spare mat, nubbly, silicone, for WA05970A and WA05971A
    WA05981A400 x 175Spare mat, nubbly, silicone, for WA05973A
    WA05990A446 x 88 x 49Instrument tray, for two telescopes, with lid
    WA05994A*478 x 68 x 224Insert tray, for camera head and adapter
    WA05995A*478 x 68 x 224Insert tray, pediatric urology
    WA05980A*595 x 61 x 295Instrument tray, for video telescope

    The Olympus sterilization trays consist of perforated bottoms with or without perforated lids. The material of the bottom is thermoplastic, the material of the lid is thermoplastic with handles and locking tabs made from medical grade stainless steel. The silicone mats for fixture of the instruments are perforated for aeration.

    The stripes are designed for minimal contact area with instruments and secure fixing.

    Olympus sterilization trays will be sold non-sterile and can be reused after proper cleaning and sterilization.

    AI/ML Overview

    The provided 510(k) summary for the Olympus Sterilization Trays (K033222) does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic AI device would. This document is a premarket notification for a medical device (sterilization trays), not an AI algorithm. Therefore, many of the requested categories are not applicable.

    However, I can extract the relevant performance data and address the applicable points based on the information provided.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity or specificity, as it's a physical medical device. Instead, performance is demonstrated through validation of its intended function.

    Feature/CriterionReported Device Performance
    Intended UseEnclose medical devices for steam sterilization.
    ReusabilityYes
    Material CompositionThermoplastic RADEL®
    DesignBase with lid, attachable by locking tab.
    Compatibility with MatsUsable with silicone mats or special silicone holders.
    Sterilant PenetrationValidated for Steam with Prevacuum.
    Microbial Barrier PropertiesTo be used with approved sterilization wrap.
    Material CompatibilityCompatible with Steam Sterilization at 134°C.
    Toxicological PropertiesMaterial biocompatible.
    Drying time10 - 20 minutes (as needed for the specified cycle).
    Sterilization Cycle (Prevacuum Steam)132°C - 134°C - 5 minutes minimum.

    No Acceptance Criteria for AI Performance are Present as This is Not an AI Device.

    2. Sample Size Used for the Test Set and Data Provenance

    This is not applicable as the device is a physical sterilization tray, not an AI model requiring a test set of data. The validation mentioned refers to the physical product's ability to withstand and facilitate sterilization.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    Not applicable. The "ground truth" here is the physical and functional performance of the device, assessed through engineering and sterilization validation studies, not expert interpretation of data.

    4. Adjudication Method for the Test Set

    Not applicable for a physical medical device.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    Not applicable. This is not an AI device, and therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

    Not applicable. This is not an AI algorithm.

    7. The Type of Ground Truth Used

    For the Olympus Sterilization Trays, the "ground truth" largely relies on:

    • Engineering specifications and material science: Verification that the materials (thermoplastic RADEL®, stainless steel, silicone) meet performance requirements for temperature, mechanical stress, and biocompatibility.
    • Sterilization efficacy validation: Demonstrated that the trays allow for proper steam penetration and drying during the specified sterilization cycle. The document explicitly states: "The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory." This PCD likely simulates the most challenging conditions for sterilization within the tray.

    8. The Sample Size for the Training Set

    Not applicable. This is a physical device, not an AI model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. This is a physical device, not an AI model. The validation for the device's performance was established through testing by a "GLP approved laboratory" using (at least) a Process Challenge Device (PCD) to ensure effective sterilization. Environmental testing and material compatibility assessments would also form part of this "ground truth" for a physical device.

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