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510(k) Data Aggregation

    K Number
    K961454
    Device Name
    AMMI MAGNI-GUARD
    Manufacturer
    AMERICAN MEDICAL MFG., INC.
    Date Cleared
    1996-07-25

    (101 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMMI MAGNI-GUARD

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

    Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.

    Device Description

    Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.

    AI/ML Overview

    The provided text describes a medical device, the AMMI MAGNI-GUARD™ Splash Prevention Device, and compares it to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves comparing design, materials, intended use, and performance characteristics (as shown in the provided table). It's a pre-market notification process, not a clinical trial report.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them because this information is not present in the provided text.

    Based on the information given, I can only extract these general points:

    • Device Type: Splash Prevention Device
    • Intended Use: To provide protection to surgical staff during surgical procedures by preventing the splashing of blood across the surgical suite.
    • Mechanism: A clear, rigid, see-through plastic guard with raised side walls and an extended handle.
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