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    K Number
    K160753
    Device Name
    COOK Vacuum Pump
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2017-06-13

    (452 days)

    Product Code
    MQG,MOG
    Regulation Number
    884.6120
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K992070
    Why did this record match?
    Device Name :

    COOK Vacuum Pump

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

    The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

    Device Description

    The COOK Vacuum Pump (K-MAR-5200) is an electrically-powered, vacuum pump that is used for the collection of ova (eggs) from ovarian follicles for use in in vitro fertilization (IVF) procedures. The COOK Vacuum Pump provides vacuum levels ranging from -10 mmHg to -500 mmHg. . It is supplied non-sterile.

    The disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) is an accessory to the COOK Vacuum Pump and is used to connect the vacuum pump to an ovum aspiration needle. This component has been designed and tested to withstand the maximum vacuum pressures associated with the COOK Vacuum Pump. The Vacuum Line with Hydrophobic Filter (K-DVLF-240) is provided sterile (ethylene oxide sterilization) for single use only, and has a shelf-life of three years.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA regarding the "COOK Vacuum Pump". This document primarily focuses on the device's substantial equivalence to a predicate device and does not contain information about clinical studies or performance data related to AI/algorithm-driven medical devices. Therefore, I cannot provide the requested information regarding acceptance criteria and study results for an AI device.

    The document discusses the following:

    • Device Name: COOK Vacuum Pump
    • Indications for Use: Aspiration of eggs (ova) during assisted reproduction procedures using low flow, intermittent vacuum.
    • Predicate Device: COOK Ultra Quiet Vacuum Pump & Regulator (K992070)
    • Technological Characteristics: Comparison of vacuum range, boost function, controller type, and presence of software.
    • Non-Clinical Performance Testing: Electrical Safety, Electromagnetic Compatibility, Software Verification and Validation, Sterilization Validation, Shelf-Life Testing.

    Specifically, regarding your request, this document does not include:

    • A table of acceptance criteria and reported AI device performance.
    • Sample sizes, data provenance, or details of a test set for an AI algorithm.
    • Information on experts used to establish ground truth for an AI test set.
    • Adjudication methods for an AI test set.
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for human readers with/without AI assistance.
    • Standalone AI algorithm performance.
    • Type of ground truth for an AI algorithm.
    • Sample size for an AI training set.
    • How ground truth for an AI training set was established.

    The "Software Verification and Validation Testing" mentioned refers to the general software development lifecycle and testing process of the embedded software controlling the vacuum pump, not to artificial intelligence or machine learning model validation.

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