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510(k) Data Aggregation

    K Number
    K190449

    Validate with FDA (Live)

    Device Name
    Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2019-08-30

    (186 days)

    Product Code
    FET,NWB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K111425,K102059
    Predicate For
    K200542,K242067
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200: This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

    VISERA ELITE IT HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA: The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

    VISERA ELITE II HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB: The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

    Device Description

    The OTV-S200 is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The OTV-S200 has a light source and video processor function. The endoscope light guide cable is connected to the output socket on the subject device and the endoscope video connector or camera head is connected to video connector socket. The OTV-S200 emits light to the endoscope via the light guide cable and receives the electrical signal from the endoscope or camera head via the video connector. After processing, the OTV-S200 outputs endoscopic images on the monitor. The subject device provides white light imaging (WLI) and narrow band imaging (NBI). The OTV-S200 function is operated by a touch panel screen.

    The CH-S200-XZ-EA and CH-S200-XZ-EB have been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The CH-S200-XZ-EA and CH-S200-XZ-EB are compatible with Olympus rigid endoscopes to be used to observe various anatomical locations. The subject devices are constructed with a camera head (body), camera cable and video connector and connected to an endoscope by the lock ring on the camera head. Light is supplied from the video system center to the rigid endoscope via a light guide cable and emitted from the distal end of the endoscope. The objective lens on the distal end of the endoscope receives the light from the object and the light guide inside the endoscope transfers the light to the eyepiece and 3CMOS (imager) inside the subject device. The imagers convert the light to an electrical signal and the signal is transferred to a video system center via the camera cable and video connector. Finally, an endoscopic image is outputted on the monitor after processing in the video system center. The subject devices provide white light imaging (WLI) and narrow band imaging (NBI). Zoom and focus are controlled by switches or rings on the camera head for the CH-S200-XZ-EA or CH-S200-XZ-EB, respectively. Three remote switches on the camera head provide operation of the video system center function by setting the functions prior to the procedure.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Visera Elite II Video System Center" (OTV-S200) and associated camera heads (CH-S200-XZ-EA, CH-S200-XZ-EB) by Olympus Medical Systems Corp.

    The submission is for a medical device that does not include AI or machine learning components. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set sample size," and "ground truth for training set" are not applicable.

    Here's the information that is available based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is an endoscopic video system and camera heads. The acceptance criteria are based on compliance with various safety and performance standards, and the reported performance indicates that these criteria were met through non-clinical testing.

    Acceptance Criteria CategoryReported Device Performance
    Reprocessing ValidationReprocessing instruction and method validation testing for the camera heads (CH-S200-XZ-EA and CH-S200-XZ-EB) were conducted and documented as recommended by FDA guidance ("Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling").
    Software Verification and ValidationSoftware verification and validation testing for the OTV-S200 were conducted and documented as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices").
    Electrical Safety and EMCElectrical safety and EMC testing were conducted on the OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB. The devices comply with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety, and IEC 60601-1-2:2014 standards for EMC.
    Bench Performance TestingBench testing for the OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB was conducted to ensure the device performs as intended and meets design specifications. This included evaluations of: - Difference for Emergency Lamp - NBI Observation - Image Quality - Photobiological safety - NBI Color Adjustment - Function of Switching of the "iris area" - Laser mode - Confirmation of Full HD image - FOV
    Risk AnalysisRisk analysis for all devices was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed as a result of this assessment.
    Voluntary Standards Compliance (Examples)The devices comply with various voluntary standards, including: - AAMI / ANSI ES 60601-1 - IEC 60601-1-2 - IEC 60601-2-18 - ISO 14971 - IEC 62304 (for OTV-S200) - ISO 17665-1 (for CH-S200-XZ-EA) - ISO 14937 (for CH-S200-XZ-EA and CH-S200-XZ-EB)

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

    This information is not explicitly stated as the testing involved performance bench tests and compliance with standards rather than a test set of patient data. The provenance for the bench test results would be Olympus's internal testing facilities (Japan, where the manufacturing site is located). The studies are non-clinical (laboratory/bench).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    Not applicable. The device is hardware (video system and camera heads) and software that manages its functions, not an AI diagnostic tool that requires expert-established ground truth on patient data. The "ground truth" for the device's performance would be the specifications and requirements defined for the hardware and software, verified through engineering tests.

    4. Adjudication Method for the Test Set

    Not applicable, as no external "test set" requiring adjudication by experts to establish ground truth was used in the context of diagnostic assessment.

    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 device does not incorporate AI or machine learning for diagnostic assistance, nor was it evaluated in an MRMC study.

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

    Not applicable. The device is a video system and camera heads for visualization, intended to be used with a human endoscopist. There is no standalone algorithm performance to evaluate.

    7. The Type of Ground Truth Used

    The "ground truth" for this medical device is adherence to engineering specifications, safety standards, and functional requirements established by the manufacturer and recognized regulatory bodies. This is verified through various non-clinical performance tests (bench testing, electrical safety, EMC, reprocessing validation, software validation, risk analysis) rather than clinical outcomes or expert consensus on medical images/data.

    8. The Sample Size for the Training Set

    Not applicable. This device is not an AI/ML product developed with a training set of data.

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

    Not applicable, as there is no training set for this type of device.

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