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510(k) Data Aggregation

    K Number
    K070815
    Device Name
    THD
    Manufacturer
    G.F. S.R.L.
    Date Cleared
    2007-06-20

    (86 days)

    Product Code
    JAF
    Regulation Number
    892.1540
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K041915,K052067
    Why did this record match?
    Applicant Name (Manufacturer) :

    G.F. S.R.L.

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

    The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit.

    The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

    Device Description

    The THD consists of the THD Evolution Doppler Device and the THD Kit. The THD Evolution Doppler is a 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler must be used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation.

    The THD Kit is a sterilized surgical kit comprised of a proctoscope, sutures, a needle holder and a knot tightener.

    AI/ML Overview

    This document details the 510(k) submission for the THD (Transanal Hemorrhoidal Dearterialization) device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The provided text is primarily a 510(k) summary, focusing on device description, indications for use, and a comparison to predicate devices for substantial equivalence.

    The "Performance Data" section solely discusses acoustic output parameters of the THD Evolution Doppler and compares them to limits for diagnostic ultrasound systems, not clinical performance for treating hemorrhoids.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence to predicate devices based on safety and basic functional characteristics, rather than a detailed performance study with specific acceptance criteria related to its clinical efficacy.

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