SFN · Non-Invasive Evoked Response Brain Stimulator

Neurology · 21 CFR 882.1860 · Class 2

Overview

Identification

The Delphi-MD System is a prescription device intended to elicit, amplify, record, and display brain evoked potentials to transcranial magnetic stimulation (TEPs) of the left and right primary motor cortex, dorsolateral prefrontal cortex, and primary visual cortex. The device is also intended to analyze TEPs and provide quantitative output parameters of the evoked response including the TEP waveform, global mean field potential, local mean field potential distribution maps, quantify amplitudes and latencies of the response, and present the output parameters compared to a normative reference database (limited to 50-75 years of age). The device is not to be relied on solely to make or confirm a diagnosis.

Classification Rationale

FDA has determined that the Delphi-MD System can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the non-invasive evoked response brain stimulator is subject to the following special controls: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use and include the following: (i) Evaluation of the device output and clinical interpretation, including repeatability and reliability of the device data outputs; (ii) Description of the construction of the normative database, including the following: (A) How the clinical work-up was completed to establish a normative population, including the establishment of inclusion and exclusion criteria; and (B) Statistical methods and model assumptions used; and (iii) Evaluation of the safety and performance of the stimulus, including mechanism of delivery and associated stimulation parameters. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the performance of the methods utilized to elicit and measure the evoked brain activity response. (3) The tissue-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate electrical safety, thermal safety, mechanical safety, electromagnetic compatibility (EMC), and wireless coexistence of the device in the intended use environment. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) A detailed description of the device technical parameters, such as stimulation parameters; (ii) An explanation of all device data outputs; (iii) Conditions of use that may impact the accuracy, reliability, or functionality of the device measurement and operation; (iv) Conditions that may preclude use of the device, such as implanted medical devices or medical conditions; (v) A statement that the device is not a standalone diagnostic device and does not replace clinical decision making; and (vi) A description of the normative database population and resulting parameters.

Recent Cleared Devices (1 of 1)

Top Applicants

• Quantalx Neuroscience, Ltd. — 1 clearance