876.1735—Electrogastrography system.
(a) Identification.
An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.
(1)
The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(i)
To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;
(ii)
To describe how background data should be gathered and used to eliminate artifact in the data signal;
(iii)
To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and
(3)
The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.
(4)
Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.