Transcranial Magnetic Stimulation (TMS)

Added: Jul 30, 2015 3:30 pm The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501(a)) with Brain Research and Development Service LTD, 19 Hartom St, POB 45169, Jerusalem, Israel 9777518, as the only responsible source that can provide Transcranial Magnetic Stimulation (TMS) System for the Naval Medical Center San Diego. This acquisition is being conducted under the FAR 13.5 test procedures for commercial items. Provisions and clauses in effect through Federal Acquisition Circular 2005-83 are incorporated.

Items being purchased in this acquisition:

Brainsway Deep TMS Full System (Quantity 1 each)

DESCRIPTION PART NO.
POWER SUPPLY 115V (3005-00) 04000015
COOLING SYSTEM 24V ASSY CLS-000001-ASM
DTMS accessories kit TOOL-000020-KIT
POSITIONING UNIT ASSY 102B MODULE UNT-000002-PASM
ADJUSTABLE ARM ASSY 580mm FOR DTMS ARM-000003-CPLX
H1-COIL HEL-100010-CPLX
IFU FOR DTMS-DEPRESSION COMMERCIAL-ENGLISH IFU-0100-00-E
ITD CART CRT-000002-ASM
patient Cap size L - Kit (includes 40 caps, each additional cap costs $25) CAP-000001-KIT
LG-100 GROUND ELECTRODE KIT ELC-000007-KIT
Marketing Kit MRK-000001-KIT
Cooling System Accessories Kit 24V TOOL-000005-KIT

Full Installation Service (Quantity 1 each)
Full Training Service (Quantity 1 each)

The system shall be capable of delivering non-invasive supra-threshold TMS to deep brain regions (Deep TMS). The system shall be indicated for the treatment of a variety of conditions including but not limited to Major Depressive Disorder (MDD), Bipolar Depression, Schizophrenia, Parkinson's Disease, and Chronic Pain. The system shall include user training for up to five (5) individuals upon installation. Installation and training shall take place on dates to be coordinated in advance. The power requirement is multiple 110VAC, 60 Hz, 20Amp outlets on separate circuits.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 500 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Based on the above information, the only technically acceptable mounting devices are provided by Brain Research and Development Service LTD.

Submit email capability statements (using PDF, MS Word, Excel attachments) to Kerry McKean at kerry.a.mckean.civ@mail.mil. Statements are due no later than 1400 ET 13 August 2015. No phone calls will be accepted.