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510(k) Data Aggregation

    K Number
    K970750
    Device Name
    MICROSPAN INSEMINATION SYSTEM
    Manufacturer
    IMAGYN MEDICAL, INC.
    Date Cleared
    1997-05-05

    (63 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROSPAN INSEMINATION SYSTEM

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

    Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.

    Device Description

    The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.

    AI/ML Overview

    The provided text is a 510(k) summary for the MicroSpan Insemination System. It describes the device, its intended use, and states that non-clinical tests were performed to demonstrate adequate performance. However, it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or any of the detailed aspects requested in the prompt.

    Therefore, I cannot provide the requested information based on the input text.

    The input document is a regulatory submission summary document, which typically focuses on describing the device and its intended use, and asserting that testing was performed, rather than providing the detailed results and methodologies of those tests. To answer your questions, one would need to refer to the actual test reports, study protocols, and results that would have been part of the full 510(k) submission.

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