66-- PERC, C-Fine and Tims Electrodes Cleveland VA

The Department of Veterans Affairs, Louis Stokes Cleveland VAMC R&D Service intends to negotiate on a sole source basis with Ardiem Medical, Inc. for their custom PERC, C-Fine and Tims Electrodes, in accordance with FAR 6.302-1. The Device Master File (MAF) at the FDA for the Flat Interface Nerve Electrode (FINE), MAF 1499, contains documentation on the manufacture of this specific electrode and Ardiem is listed as the sole provider for the manufacture of these highly specialized electrode leads. In order to determined capable, potential vendors must have the specified equipment for the coiling, welding, and the final assembly of the electrode lead. They must also have a Class 7 (10,000) Cleanroom required for the manufacturing of these leads (the Centers and many other suppliers do not). They must be registered with the FDA as a contract manufacturer for these operations. They must be able to provide Intramuscular electrodes both stimulating and recording, Epimysial electrodes both stimulating and recording, and Spiral Cuff electrode that the APT Center is providing to other research centers and investigators across the country. This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Tuesday July 10, 2018, 11:00 am, EST. Interest/capability statements may be sent to Elaine DiBucci at contact@example.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.