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510(k) Data Aggregation

    K Number
    K100803
    Device Name
    OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
    Manufacturer
    KEYMED, INC.
    Date Cleared
    2010-04-22

    (31 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K000948
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized.

    Device Description

    The Olympus Flushing Pump is peristaltic pump which facilitates direct washing of debris from the observation site during endoscopic examinations. The peristaltic pump and associated tubing allow irrigation water to be controlled and directed to the observation site to remove blood, faeces or other organic matter that may be obstructing the endoscopic view.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Olympus Flushing Pump OFP-1, specifically focusing on a modification to the Auxiliary Water Irrigation Tube. This is a special 510(k) as stated in section 8, meaning the performance testing is focused on validating the changes, which are a material change and sterilization of the tubing.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria/TestsReported Device Performance
    BiocompatibilityBiocompatibility of new PVC tubing"Biocompatibility testing of the PVC tubing" - Implied successful, as substantial equivalence was granted.
    SterilizationValidation of Gamma Sterilization Process for tubing"Validation of the Gamma Sterilization Process" - Implied successful.
    Packaging IntegrityValidation of Irrigation Tube Packaging"Validation of the Irrigation Tube Packaging" - Implied successful.
    Functional PerformancePerformance testing of the new irrigation tube"Performance testing of the new irrigation tube has demonstrated that the OFP fulfills prospectively defined performance criteria and that the modified system meets user needs." - Implied successful.
    Intended UseDevice continues to operate as intended"The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized." - Intended Use remains unchanged, implies device still supports it.

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

    The document does not specify the exact sample sizes for each of the validation activities (biocompatibility, sterilization, packaging, performance testing). Given this is a modification to a previously cleared device, the testing would be focused on the new components/processes.

    The provenance of the data is not explicitly stated. However, the sponsor is KeyMed (Medical & Industrial) Ltd. in the United Kingdom, suggesting the testing might have been conducted there or by a contract research organization. The study type is retrospective in the sense that it's a validation of a modified product against established performance criteria, rather than a prospective clinical trial.

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

    This information is not provided in the document. The performance testing focuses on engineering and material validation rather than clinical ground truth established by experts.

    4. Adjudication Method for the Test Set

    This information is not provided. Given the nature of the validation (biocompatibility, sterilization, packaging, and functional performance of a tube), adjudication by experts, as typically seen in clinical studies, would not be applicable. The adjudication would be against pre-defined engineering and regulatory standards.

    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, an MRMC comparative effectiveness study was not done. This device is an endoscopic flushing pump, not an AI-powered diagnostic tool. The submission is for a material and sterilization modification to an existing mechanical device. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not relevant to this submission.

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

    No, a standalone (algorithm only) performance study was not conducted. This is a mechanical device, not an algorithm.

    7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

    The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus, pathology) is not applicable to this submission. The "ground truth" here is based on:

    • Engineering Standards and Specifications: For functional performance of the flushing tube (e.g., flow rate, pressure, durability).
    • Biocompatibility Standards: ISO 10993 series for the PVC tubing.
    • Sterilization Standards: ISO 11137 series for gamma sterilization.
    • Packaging Standards: Relevant standards for sterile medical device packaging.

    8. The Sample Size for the Training Set

    There is no training set. This is a mechanical device modification, not a machine learning or AI algorithm that requires a training set.

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

    This question is not applicable as there is no training set for this device.

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