(56 days)
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffhess as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® 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®, 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 speed of propagation of the shear (elastic) wave is measured using ultrasounds. A new FibroScan® parameter labeled CAP (Controlled Attenuation Parameter), ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total aforementioned ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
The provided text describes the FibroScan® system, which performs non-invasive measurements of liver shear wave speed and tissue stiffness, as well as an ultrasound coefficient of attenuation (CAP). The new submission (K150949) focuses on the addition of CAP measurements.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather as comparative performance to the predicate devices. The performance is assessed in terms of bias and precision for both shear wave measurements (from the predicate FibroScan®) and the new CAP measurements (from the candidate FibroScan®).
| Metric | Acceptance Criteria (inferred: similar or better than predicate) | FibroScan® Predicate Device Performance (Shear Wave) | Candidate Device Performance (CAP) |
|---|---|---|---|
| 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.