(58 days)
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.
| Performance Metric | Acceptance Criteria (based on predicate FibroScan® 530 Compact) | Reported Device Performance (FibroScan® 430 Mini+) |
|---|---|---|
| Shear Wave Speed Bias | M+ probe: |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.