NeurAxis IB-Stim (01-1020)

The NeurAxis IB-Stim is a battery-operated, disposable nerve stimulator placed behind the ear with needles on the auricle that delivers low-frequency electrical pulses. It is intended for patients 8 years and older with functional abdominal pain from irritable bowel syndrome or functional dyspepsia, used for 120 hours per week over 4 consecutive weeks as an aid to reduce pain when combined with other therapies.

The device is identical in design, materials, packaging, sterilization, and labeling to the predicate device. It consists of a percutaneous electrical nerve field stimulator, sterile multi-pin wire harness array with a 1-1-1-4 configuration, bandages, skin adhesive, alcohol swabs, dressing, biohazard bag, patient ID card, tweezers, surgical marker, and a transilluminator for identifying nerve bundles via trans-illumination technique.

Not stated in this summary.

The subject device is substantially equivalent to the predicate NeurAxis IB-Stim (K250451) because the design, materials, packaging, sterilization, and package labeling are identical. The only change is expansion of the indication from patients 8-21 years of age to 8 years and older; clinical data from pediatric and adolescent studies combined with literature extrapolation to adults supports that this age expansion does not raise new safety or effectiveness questions.