6640--ISENS SMART LEAD COMPONENT

SPECIAL NOTICE NOTICE OF INTENT TO SOLE SOURCE iSens Smart Lead Component The Department of Veterans Affairs Cleveland Medical Center (CLE VAMC), 10701 East Blvd., Cleveland, OH 44106 intends to solicit and negotiate with only one source under the authority of FAR 13.106(b)(1)(i) - Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The NAICS code is 334419 with a small business size standard of 750. The VA intends to solicit and negotiate with Ardiem Medical, Inc., 1125 Wayne Avenue, 22534 for iSens Smart Lead Components. Item Description: Materials to build 36 Smart Modules and 36 Stim Modules; Materials include: Fully assembled Nexlogic flex circuits, Cans with laser marking, 4 pin feedthroughs, 32 pin feedthroughs, weld rings, EM top shields, EM bottom shields, 32 pin spacers. Components used for implanting the iSens system must be FDA-approved under an IDE for this particular use case. These components are the only ones in existence that meet that requirement. Attached, please find the following: Authorized distributor letter Brochure Salient characteristics Specification sheet Other persons may identify their interest and capability to respond to this requirement by Tuesday, May 9, 2023, at 5PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis.  All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Rachelle Hamer at [email protected]. Enter RFQ 36C25023Q0676| iSens Smart Lead Component in the email subject line.