6515--COOLIEF ADVANCED GENERATOR

DEPARTMENT OF VETERANS AFFAIRS Justification for Brand Name Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C250-22-AP-4802 Contracting Activity: Department of Veterans Affairs, VISN 10 Department of Veterans Affairs, VISN 10 2215 Fuller Rd Ann Arbor MI 481 2237 # 506-22-3-118-0356 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: $62,073.91 This is a Brand Name Only Procurement. The Pain Section is requesting this Cooled Radiofrequency system to better treat veterans with chronic pain. The leading minimally invasive and non-narcotic RF procedure that leads to better patient outcomes and improved physical functionality. This RF has proven to be effective for chronic pain relief for up to 24 months as well has the capability to deliver 3.7X more energy than standard RF. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA __________________ __________________ COOLIEF, COOLED RF ADVANCED GENERATOR LOCAL STOCK NUMBER: CRG-ADVANCED 0002 1.00 EA __________________ __________________ COOLIEF MULTI-COOLED RF THERAPY CABLE LOCAL STOCK NUMBER: CRX-CRG-MCRF 0003 1.00 EA __________________ __________________ MULTI-RF THERAPY CABLE LOCAL STOCK NUMBER: SRX-CRG-MRF 0004 1.00 EA __________________ __________________ COOLIEF QUAD PUMP UNIT LOCAL STOCK NUMBER: CRA-QPU-1 0005 8.00 EA __________________ __________________ AVANOS NITINOL RF PROBE CURVED 100 LOCAL STOCK NUMBER: PMP-100C-N 0006 8.00 EA __________________ __________________ AVANOS NITINOL RF PROBE CURVED 145 LOCAL STOCK NUMBER: PMP-145C-N 0007 16.00 EA __________________ __________________ RADIOFREQUENCY AUTOCLAVE CASE LOCAL STOCK NUMBER: PMA-AC-100675 GRAND TOTAL __________________ Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This is a Brand Name Only Procurement. Cooled RF Probe used with this system is FDA cleared to treat osteoarthritis knee pain. RF Generator, Advanced, utilizing the TransDiscal System, encompasses a Bipolar, Cooled RF mode for Intervertebral Disc Biacuplasty. This procedure places two introducers bilaterally into the posterolateral disc. This allows for a larger therapeutic treatment zone for the ablation of the nociceptor nerves. No other system has this feature. Description of market research conducted and results or statement why it was not conducted: Searched VetBiz using NAICS code 334510 and keywords RF Generator. Located 23 SD/VOSB vendors matching the search. Avanos (OEM) is a large business, and they have 2 SDVOSB and 1 WOSB vendor for this product. The VA Rule of Two cannot be attained for this purchase. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ Percy Johnson Contracting Officer