Reviewed

Brainsight Navigator for Non-Invasive Brain Stimulation (NIBS) with Computer and Electromyography (EMG), and Upgrade kit for MRI compatibility

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/16/2023

Procurement Summary

This requisition is to purchase a Brainsight Navigator for Non-Invasive Brain Stimulation (NIBS) with Computer and Electromyography (EMG), and Upgrade kit for MRI compatibility. Items supplied: • Brainsight for NIBS with computer & EMG o Brainsight Neuronavigation Software for TMS w. 5 years of updates o Northern Digital Polaris Lyra, Pwr supply & cables Page 2 of 7 o Camera Stand for Lyra o Complete Tracker Kit (pointer, coil tracker, subject tracker, calibration tool, subject head tracker elastic band, subject tracker glasses, 1 coil tracker fixation adapter, 1 coil calibration jig, 3 extra reflective spheres) o Apple Mac Minicomputer (24.0GB RAM, 27" 5k Apple Studio Monitor) o I/O box w. 2 TTL trigger inputs one switch compatible input & 3 Ethernet ports o 2 channel MEP amplifiers opto-isolation unit & isolation transformer o Mobile Trolley • Upgrade kit for MRI compatibility (with Vega) o NDI Vega camera with MRI compatible stand and Optical Ethernet adapter o MRI compatible Tracker Kit (pointer, coil tracker, subject tracker) with adapter for MagVenture MRI coil. • Technical Support: o Brainsight Software: 5 years of updates, o Computer: 3 Years (AppleCare warranty) o Other hardware: 1 year, parts & labor for manufacturer defects

Waiver Rationale Summary

The Magnetic Resonance Imaging (MRI) compatible Brainsight Navigator for non-invasive brain stimulation (NIBS) is needed to support the Study entitled, “Non-invasive Brain Stimulation Technique Development: Substudy 3 (Controlling Ongoing Cortical State during NIBS with Neurofeedback)" in order to precisely target the Transcranial Magnetic Stimulation (TMS) induced magnetic and electric field for concurrent TMS/fMRI projects based on individually determined locations and orientations. The Brainsight system is compatible with the MagVenture TMS Device that is also being used in the same study. The system includes all software and hardware and all of the components have been determined to be MRI safe. The NIMH Strategic Plan for Research’s top goal is to “define brain mechanisms underlying complex behaviors”. The goal of the study entitled, “Non-invasive Brain Stimulation Technique Development: Substudy 3 (Controlling Ongoing Cortical State during NIBS with Neurofeedback)" is to explore the use of real-time fMRI neurofeedback to control the activated state of the amygdala while it is targeted transynaptically with short trains of 5 Hz rTMS using individualized fMRI-based targeting.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

07/28/2023

Procurement Instrument Identifier (PIID)

Solicitation ID

75N95023Q00484

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH