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510(k) Data Aggregation

    K Number
    K232459
    Device Name
    Velacur
    Manufacturer
    Sonic Incytes
    Date Cleared
    2023-09-12

    (28 days)

    Product Code
    IYO,ITX
    Regulation Number
    892.1560
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K223287
    Why did this record match?
    Reference Devices :

    K223287

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

    Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz) and coefficient of attenuation. The device is indicated to non-invasively determine liver tissue stiffness and attenuation. These are meant to be used in conjunction with other clinical indicators in order to assist in clinical management of patients with liver disease. The device is intended to be used in a clinical setting and by appropriately trained medical professionals.

    Device Description

    Velacur is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam. The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation.

    AI/ML Overview

    The provided document is a 510(k) premarket notification summary for the Velacur device, which is an ultrasound elastography system. The document focuses on demonstrating substantial equivalence to a predicate device, specifically regarding algorithmic changes for elasticity and attenuation calculations.

    Here's an analysis based on the provided text, addressing your questions:

    1. A table of acceptance criteria and the reported device performance

    ParameterAcceptance Criteria (Maximum)Reported Device Performance
    Elasticity (Homogeneous Phantoms)
    Bias between MRE & Velacur
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