NeurAxis IB-Stim (01-1020)

The IB-Stim is a battery-operated, disposable nerve stimulation device weighing 5 grams that delivers low-frequency electrical pulses to branches of cranial nerves and occipital nerves via needles placed on the ear. It is intended for patients aged 8-21 years with functional abdominal pain associated with irritable bowel syndrome (IBS) and/or functional dyspepsia (FD), used for 120 hours per week over 4 consecutive weeks as an aid in pain reduction when combined with other therapies.

The device consists of a percutaneous electrical nerve field stimulator (PENFS), a sterile multi-pin wire harness with 4 leads in a 1-1-1-4 configuration (three single-needle leads and one 4-needle array), adhesive bandages, skin adhesive, alcohol swab, transparent dressing, a transilluminator for identifying nerve bundles, and accessory items. Design, materials, packaging, sterilization, and package labeling are identical to the predicate device.

Not stated in this summary.

The subject device is substantially equivalent to the predicate (NeurAxis IB-Stim K241533) because the design, materials, packaging, sterilization, and labeling are identical. No design changes were made, so previously conducted performance testing from DEN180057 remains applicable. The indication for use is expanded to include functional dyspepsia based on post-hoc clinical data from 23 FD subjects showing 54% of active IB-Stim patients maintained ≥30% pain reduction versus 0% in sham controls, supported by clinical literature and NASPGHAN recommendations for PENFS use in functional abdominal pain, without raising new safety or effectiveness concerns.