# K163326: SmartEP

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Sep 29, 2017 after 305 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002985 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070608: Smartep, Model M010000, Intelligent Hearing Systems (2007) Summary page 5.
- K143670: Ics Chartr EP 200 with Vemp, Gn Otometrics A/S (2015) Summary page 5.

## Most influential descendants
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring. The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring. The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist’s, EP technologist’s, surgeon’s, or physician’s office, operating room, or other appropriate setting. The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient’s ear (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient’s scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient’s upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient’s scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for visual evoked potential (VEP) testing are the patient’s scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient’s nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient’s tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient’s scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient’s ear (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient’s head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).

Source page: https://510kreport.com/device/K163326
Methodology: https://510kreport.com/methodology