Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C261-26-AP-4423

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO FAR Part 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C261-26-AP-4423 JOFOC Tracker 26: FY26-NCO 21-2065

1. Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement

Office West (RPOW), Veterans Integrated Service Network (VISN) 5, Health Service Area (HSA) 5.2, Network Contracting Office (NCO) 21, San Francisco VA Medical Center (SFVAMC).

2237: 662-26-3-296-0119.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

VA San Francisco Medical Center has a requirement for EnSite X EP Mapping System & Peripherals because the current Abbott arrhythmia mapping system is at end-of-life cycle. The new EnSite system introduces several advanced features that significantly enhance both patient/Veteran safety and procedural efficiency. These improvements also enable the use of the software for pulsed field ablation, a novel energy source that offers faster, safer, and potentially more effective ablation outcomes.

Estimated Amount: $340,000.00

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The EnSite™ X EP System and its associated EnSite X EP Mapping System & Peripherals possess unique, proprietary characteristics that limit availability to a single source Abbott Laboratories Inc. because the hardware, software, and sensor-enabled components are engineered as an integrated, closed ecosystem that no other manufacturer can replicate or support. These systems rely on Abbott-specific mapping algorithms, impedance and magnetic localization technologies, and specialized peripherals such as the EnSite X Amplifier, Field Frame, and patient reference sensors, all of which are trademarked and exclusively produced by Abbott Laboratories Inc. Their functionality, compatibility, and clinical performance depend on this tightly controlled design, meaning no alternative supplier can provide equipment that meets the required standards for interoperability, safety, or procedural capability, thereby restricting procurement to Abbott Laboratories Inc. alone.

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# 36C261-26-AP-4423

4. Description of market research conducted and results or statement why it was not conducted:

The General Services Administration (GSA) Advantage and VA National Acquisition Center (NAC), databases were queried using product number “ENSITE X SYS and EX912-1 ,” and no matching contract items or catalog entries were found.

Supply Chain Master Catalog (SCMC) databases were queried and found ENSITE X SYS on SCMC awarded to Abbott Laboratories Inc.

Market research confirms that the EnSite™ X EP System and the EnSite™ X EP Mapping System & Peripherals are proprietary technologies exclusively manufactured by Abbott. These systems function as an integrated hardware-and-software ecosystem protected by Abbott’s intellectual property. No third-party manufacturers produce mapping systems or peripherals that are compatible with, or certified by the OEM for use with, the existing EnSite platform. While resellers and distributors may offer the equipment, all vendors ultimately supply the same Abbott-manufactured products. Therefore, any competition would occur only among distributors of the identical brand-name system rather than among alternative manufacturers or comparable products.

Although the SBA DSBS search under NAICS 334510 identified a large number of SDVOSBs and VOSBs in the broader medical device and equipment manufacturing space, none of these results demonstrated specific OEM status or documented authorization to manufacture or supply the EnSite™ X EP System, and no SDVOSB/VOSB sources were identified via other market research methods as able to provide the requirements. Thus, the VA Rule of Two is not met.

5. Contracting Officer's Certification: Purchase is approved in accordance with

Revolutionary FAR Overhaul (RFO) FAR Part 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.