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510(k) Data Aggregation

    K Number
    K160524
    Device Name
    FibroScan 530 Compact
    Manufacturer
    ECHOSENS
    Date Cleared
    2016-03-18

    (22 days)

    Product Code
    IYO,ITX
    Regulation Number
    892.1560
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K150949
    Why did this record match?
    Device Name :

    FibroScan 530 Compact

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

    The FibroScan® 530 Compact system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.

    FibroScan® 530 Compact is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease.

    Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

    Device Description

    FibroScan® 530 Compact, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The FibroScan® 530 Compact CAP (Controlled Attenuation Parameter, ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.

    AI/ML Overview

    This document describes the FibroScan® 530 Compact system, an ultrasound device for measuring liver shear wave speed (tissue stiffness) and Controlled Attenuation Parameter (CAP). The device is intended to aid in the clinical management of adult and pediatric patients with liver disease. The provided text outlines a 510(k) summary for FDA clearance, comparing the new device to a predicate device (FibroScan® K150949).

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by comparing the performance of the FibroScan® 530 Compact against its predicate device (FibroScan® K150949). The goal is to demonstrate "similar or better" performance.

    Metric (Type)Acceptance Criteria (Predicate Performance Range)Reported Device Performance (FibroScan® 530 Compact Range)Outcome (vs. Predicate)
    Shear Wave Speed Bias (M+ probe)
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