NIRX Functional near-infrared spectroscopy (fNIRS) System and Associated Components

Title: NIRX Functional near-infrared spectroscopy (fNIRS) System and Associated Components Document type: Combined Synopsis/Intent to Sole Source Solicitation Number: RFQ# 75N91021Q00064 Proposed Post Date: 04/20/2021 Proposed Response Date: 04/30/2021 Classification Code: 66 NAICS Code: 334510 Small Business Size Standard: 1,250 Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 8490 Progress Drive Suite 400, Frederick, MD 21701 USA. Description: The National Center for Complementary and Integrative Health (NCCIH) has identified a need to procure on a sole source basis a NIRX Functional near-infrared spectroscopy (fNIRS) system and associated components, from NIRx Medical Technologies, LLC, 15 Cherry Lane, Glen Head, NY USA 11545. The acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(2) and 41 U.S.C. 1901 and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing and the business size standard is 1,250 employees. A major portion of the clinical research performed at NCCIH involves the use of functional MRI (fMRI) to understand the neural mechanisms of pain. However, some patient populations have conditions that do not easily allow them to participate in fMRI studies. The NIRX fNIRS system is a non-invasive, easily portable system that measures changes in oxygenated and deoxygenated hemoglobin. The NIRX fNIRS system is an alternative to fMRI that can be used in a normal clinical or laboratory setting on patients that cannot undergo fMRI scans, e.g., patients with intellectual deficits, patients who cannot stay still, and patients with psychological contraindications such as claustrophobia. Compared to other manufacturers, the NIRX fNIRS system in particular is 1) the most reliable and widely used system in research with over 200 publications; 2) uniquely designed to integrate with electroencephalogram (EEG; Brain Vision), transcranial magnetic stimulation (TMS), eye-tracking, and MRI for simultaneous recording (the latter three of which we currently use); and 3) has the fastest patient set-up time to increase efficiency and patient comfort. The Contractor shall provide/perform the following, unless otherwise noted: TECHNICAL REQUIREMENTS: The Contractor shall deliver one brand name NIRX Functional near-infrared spectroscopy (fNIRS) system and associated components. Under the service agreement the Contractor shall respond with 24 hrs. and be onsite within an additional 24 hrs. to provide service. Installation shall include: One day onsite installation and training. 5 hour online remote installation and training for fNIRS acquisition, experimental design, and basic analysis overview. Software covered: NIRStar or Aurora; NIRSite. 5 hour online remote installation and training for fNIRS analysis; software environment must be specified by NCCIH before purchase. Software covered: nirsLAB Salient Characteristics: NIRScout X+ Core system Unit: NIRScout X+ Chassis (4x source bays, 8x laser module bays, 8x detector bays, 8-bit trigger input/output, 100Hz sampling rate max)- Static calibration phantom- dual-arm articulating assembly (up to 6x fiber bundles, 4x active bundles) - NIRScap prep kit (e.g., cable stabilizing accessories, cap prep/cleaning consumables, etc.)- NIRScout X cable set (trigger, data, power)- NIRStar recording software: realtime data streams, brain activation, and block averages; data export; BCI/neurofeedback ready; Lab-Streaming Layer (LSL) integration- True raw data format (light intensity: Volts) for analysis in nirsLAB, Homer2, NIRS toolbox, etc.- System carrying case- NIRScout documentation and manuals Compatible with Microsoft Windows 10 Source Drivers for Laser source leads: 2x hybrid source driver cards. Powers up to 32x 2-wavelength or 16x 4-wavelength lasers; or 32x 2-wavelength LEDs. Requires 2- or 4-wavelength laser Module (for Lasers) and probe sets (both Lasers and/or LEDs). 8x Avalanche Photodiode (APD) detector cards: Connects up to 32x detector leads. Requires probe set. 2-wavelength laser module w/8x source lead connections (or 2x bundles) for NIRScoutX Plus chassis. Requires 1x hybrid/LED laser driver; 1x free laser module bay in system chassis. Bundle of 4 x laser source fibers dual tip: 240cm long (please specify if shorter or longer lengths desired, PMD-FBO-EXT required for longer lengths). Includes 1x tree-style cable organizer (TREE-STD). Bundle of 4x detector fibers with dual tip: 240cm long (please specify if shorter or longer lengths desired, PMD-FBO-EXT required for longer lengths) Includes 1x tree-style cable organizer (TREE-STD). 128-position NIRScap with 128x unpopulated 'slits' for NIRS in 10-5 layout: NIRS positions require grommets and probes for measurements. Includes numbered and colored labels. Includes labeled 'standard' EEG landmarks. Grommet tops: Set strength grommet tops with low-tension spring to secure standard, dual, and blunt-tipped probes for improved comfort (secures to retrofit grommet base and MRI/TMS-compatible low-profile base). Tension = 1/3. Set strength grommet tops with medium-tension spring to secure standard, dual, and blunt-tipped probes for improved data quality (secures to retrofit grommet base and MRI/TMS-compatible low-profile base). Tension = 2/3. Set strength grommet tops with high-tension spring to secure standard, dual, and blunt-tipped probes for maximum data quality (secures to retrofit grommet base and MRI/TMS-compatible low-profile base). Tension = 3/3. Retrofit grommet base - fits with spring-loaded grommet top Acticap-style 'standard' grommets for NIRScaps. Fits standard-tipped and dual-tipped probes. Bundle of 8x short-channel detectors with specialized ring grommets that fit to spring-loaded and low-profile grommets. Splits a single detector into 8 short channels that may be placed anywhere on a single NIRScap. One bundle suggested per NIRScap. Includes interface for standard, blunt and dual tipped probes to work with NIRx NIRScout or NIRSport; please specify if other interfaces would be required. NIRx Medical Technologies, LLC is the only known manufacturer of a name NIRX Functional near-infrared spectroscopy (fNIRS) system and associated components with the above salient characteristics. REPORTING REQUIREMENTS AND DELIVERABLES: The Contractor shall deliver the instrument within 60 calendar days after the purchase order is awarded to: Eleni Frangos, Ph.D., 10 Center Dr, Bldg 10 RM 7C315, Bethesda, MD 20892. The Contractor that receives the award will be provided with the complete mailing address and point of contact. PAYMENT: Net 30 days from date of invoice. Payment shall be made after acceptance of the deliverables, and submission of invoice pursuant to the invoicing instructions, and to the address shown, in the contract/order. Only one award will be made and will be awarded as a firm fixed price type contract. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 2:00PM EDT, on Friday, April 30, 2021. All responses and questions must be in writing and sent to Mary Muir, Contracting Officer, via electronic mail at contact@example.gov. No calls will be accepted. A determination by the Government not to complete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have a valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference RFQ# 75N91021Q00064 on all correspondence. See attached draft Statement of Work.