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510(k) Data Aggregation

    K Number
    K191291
    Device Name
    Wallace Dual Lumen Oocyte Recovery System
    Manufacturer
    CooperSurgical, Inc.
    Date Cleared
    2019-06-12

    (29 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Type
    Special
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K182959
    Why did this record match?
    Reference Devices :

    K182959

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

    The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

    Device Description

    The Wallace Dual Lumen Oocyte Recovery System consists of a 33 cm dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System is available in 16 or 17-gauge color-coded sizes (16G-Blue and 17G-Red). The needles are available in three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Wallace Dual Lumen Oocyte Recovery System) and does not contain information about studies related to AI or algorithm performance. The content focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical attributes, such as needle size, biocompatibility, stability, shelf life, and mechanical performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance, as these details are not present in the given document.

    The document indicates that the device is a sterile, single-use system for ultrasonic-guided transvaginal collection of oocytes and does not mention any AI or software components.

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