(116 days)
FibroScan® is intended to provide 50Hz shear wave velocity measurements through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (Mode of Operation: N, Other*: N 1, 2)
FibroScan® uses transient elastography for the non-invasive measurement of liver shear wave speed. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. Ultrasound is used to track the shear wave and to measure its speed, which is correlated with the elasticity of the liver.
The document describes the FibroScan® System, an ultrasound device for non-invasive measurement of shear wave speed in the liver. The provided text primarily focuses on non-clinical performance data and does not contain information about clinical studies with human participants that establish acceptance criteria and device performance based on those criteria.
Here's the relevant information based on the provided text regarding the non-clinical performance:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by comparison to a predicate device.
| Performance Metric | Acceptance Criteria (Implied from Predicate Device) | Reported Device Performance (FibroScan®) |
|---|---|---|
| Bias (Difference in mean shear wave speed, normalized, in percent) | Overall range of bias values ~50% (Range: -9.4% to 43.4%) | Overall range of bias values |
§ 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.