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510(k) Data Aggregation

    K Number
    K983985
    Device Name
    HYBRISONIC SHEATH
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    1999-02-25

    (108 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYBRISONIC SHEATH

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

    Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, intended for use in sterile and non-sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures when used alone or in combination with an ultrasound coupling gel or fluid alone or in combination with a latex, polypropylene protective transducer cover. The Combination are intended to be used without additional lubrication for typically ultrasound such as ultrasound guided biopsy and aspiration.

    Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer Microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue with the transducer, are single use and disposable.

    Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use as a device lubricant and microbial barrier during transcutaneous ultrasound exams and with ultrasound imaging and transcutaneous ultrasound guided biopsy or aspiration.

    Device Description

    HybriSonic Sheath

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "HybriSonic Sheath" but does not contain information regarding acceptance criteria, study details, or performance results.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication method.
    • MRMC comparative effectiveness study results or effect size.
    • Standalone performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document is a clearance letter from the FDA, confirming the device's substantial equivalence to a predicate device for its stated indications for use, without detailing the specific studies or performance metrics used to reach that conclusion.

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