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510(k) Data Aggregation

    K Number
    K991271
    Device Name
    OOCYTE ASPIRATION NEEDLE
    Manufacturer
    CASMED UK
    Date Cleared
    2000-03-08

    (330 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for Oocyte Aspiration Needles and an "Indications for Use Form." This document confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (as outlined in your request) is not present in the provided text. The document does not contain details about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for the training set was established.

    This FDA letter is a regulatory approval document and not a scientific study report.

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