StimTrial Neuromodulation System

The StimTrial Neuromodulation System is a temporary peripheral nerve stimulation device used for trial stimulation lasting no longer than 30 days to determine if a patient is a good candidate for a permanent implant. It works by delivering electrical impulses from a wearable external stimulator through a percutaneously placed lead to a target peripheral nerve, intended to interrupt pain signals and produce paresthesia (tingling/numbness) to manage severe intractable chronic pain of peripheral nerve origin as an adjunct to other therapies.

The StimTrial System uses a single stimulating electrode (divided into 3 segments) with 6.3 mm² surface area and platinum-iridium electrodes, delivers monopolar current-regulated stimulation at 1–200 Hz and 100–500 μs pulse width with maximum 10 mA amplitude and 5.0 μC charge per pulse. The external stimulator uses a rechargeable lithium-ion polymer battery, communicates via Bluetooth Low Energy, and is worn with a hydrogel skin electrode patch (28 cm²). These parameters fall within or closely match the Nalu predicate device specifications.

Not stated in this summary.

Bioventus argues substantial equivalence based on three predicates sharing the same indications (trial stimulation for peripheral nerve pain), regulatory classification, and mode of operation (external stimulator delivering electrical energy to a percutaneously placed lead targeting peripheral nerves). The StimTrial's stimulation parameters (current amplitude, frequency, pulse width, charge density) are either identical to or within the range of the primary predicate (Nalu), and the device uses the same well-established materials (platinum-iridium electrodes, silicone insulation) with a long history in implanted devices. Differences in electrode array length, number of electrodes, and external stimulator design do not affect safety or effectiveness because they do not change the fundamental principle of operation or introduce new safety concerns, as demonstrated by comprehensive labeling, software, electrical safety, usability, bench, animal, biocompatibility, and sterilization testing.