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510(k) Data Aggregation

    K Number
    K112827
    Device Name
    SHEATHES ULTRASOND GEL
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Date Cleared
    2012-06-22

    (268 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K883917,K101952
    Why did this record match?
    Device Name :

    SHEATHES ULTRASOND GEL

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

    Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

    Device Description

    Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Product categories/models include Individual packets (non-sterile) and Bulk bottles (non-sterile). Gel is for single patient/procedure, disposable use.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for "Sheathes™ Ultrasound Gel," an ultrasound couplant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not involve studies related to device performance in an imaging context that would require ground truth, expert review, or human reader studies.

    Therefore, many of the requested sections (2 through 9) related to clinical study design, ground truth, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as this is a non-clinical device that does not perform diagnostic functions.

    Here's an analysis of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device Name: Sheathes™ Ultrasound Gel
    Predicate Devices:

    • Sonotech Natural Image Ultrasound Couplant (510K#K883917)
    • Konix Ultrasound Gel (510K#K101952)
    Criteria CategoryAcceptance Criteria (against predicate devices)Reported Device Performance and Conclusion
    BiocompatibilityMeets ISO 10993-1:2009 for Irritation/Intracutaneous Toxicity and Sensitization. Cytotoxicity equivalent to predicate.Irritation/Intracutaneous Toxicity: Sheathing Technologies's ultrasound gel meets the ISO 10993-1:2009 standard.
    Sensitization: Sheathing Technologies's ultrasound gel meets the ISO 10993-1:2009 standard.
    Cytotoxicity: Equivalent to Sonotech's Natural Image Couplant.
    Acoustical PerformanceEquivalent acoustical performance to predicate devices (specifically Konix Ultrasound Gel).Sound Velocity: Within the range measured in the predicate devices.
    Acoustic Impedance: Within the range measured in the predicate devices.
    Sound Attenuation: Within the range measured in the predicate devices.
    Physical MeasurementsDensity and Viscosity within the range measured in the predicate devices.Density: Within the range measured in the predicate devices.
    Viscosity: Within the range measured in the predicate devices.

    Regarding the other requested information:

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

      • Not applicable. The provided document describes non-clinical bench testing and biocompatibility assessments, not a clinical test set with patient data.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not applicable. No ground truth was established by experts for a clinical test set.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not applicable. No clinical test set requiring adjudication was performed.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not applicable. This device is an ultrasound couplant, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • Not applicable. This is a physical device (ultrasound gel), not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

      • Not applicable. The "ground truth" for this device's performance is based on established ISO standards for biocompatibility and technical specifications (e.g., acoustical properties, density, viscosity) compared against legally marketed predicate devices.

    7. The sample size for the training set:

      • Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

    8. How the ground truth for the training set was established:

      • Not applicable. No training set or associated ground truth was established for this device.
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