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The FibroScan® 430 Mini+ 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® 430 Mini+ 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.

FibroScan® 430 Mini+, 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® 430 Mini+ 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.

The FibroScan® 430 Mini+ system, a diagnostic ultrasound device, was evaluated for substantial equivalence to the FibroScan® 530 Compact system. The evaluation focused on the device's ability to measure shear wave speed and Controlled Attenuation Parameter (CAP) for liver stiffness and fat assessment, respectively.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FibroScan® 430 Mini+ were based on demonstrating comparable or better performance (bias and precision) to its predicate device, FibroScan® 530 Compact, when tested on calibrated phantoms.

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