BRAND NAME JUSTIFICATION_Redacted.pdf

Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

BRAND NAME ONLY

Acquisition Plan Action ID:

RPOW JOFOC Tracker:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 21, in support of VA Medical Facility San Francisco, 4150 Clement Street, San Francisco, CA 94121-1563 2237:

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The San Francisco VA Medical Center (VAMC) has a requirement for a Barrx HaloFlex Energy Generator to treat dysplastic Barrett’s esophagus while preserving underlying submucosal tissue. The estimated price is and necessary items include:

HALOFLEX ENERGY GENERATOR, 1190A-115A, qty:1

3. 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 requirement. No other manufacturer designs, produces, or distributes a system with the proprietary HALO radiofrequency ablation technology. The device's unique compatibility with Medtronic's HALO catheters, safety features, and proven clinical effectiveness further necessitate sourcing directly from the OEM or its authorized distributors. The Barrx HALO Generator has the following proprietary features that are not available from any other manufacturer:

• Controlled radiofrequency energy delivery

• Multiple applicator compatibility

• Real-time feedback and safety features

• Minimally invasive and outpatient use

• Proven clinical effectiveness

Additionally, this is a replacement generator so only the Barrx HaloFlex is compatible with existing accessories and connections. Consideration of any other device or system would create significant duplication of costs and would not be to the benefit of the Government

4. Description of market research conducted and results or statement why it was not conducted: A review of the FDA database for devices under the same product code (GEI), resulted in more than 100 approved devices but none known to meet the requirements, including compatibility with existing equipment. Market research was limited to the HaloFlex generator as it is part of a proprietary system, and no others

Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# are known to be compatible. A market research outreach was made to the Original Equipment Manufacturer (OEM) and several SDVOSB distributors were identified as capable of providing the necessary equipment. The Non-Manufacturer Rule was reviewed and determined to be applicable and to limit the set-aside to a small business level given the large business OEM.

5. 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.