RFO Part 12 Under SAT AI Endoscopy Module red_Redacted.pdf

Acquisition ID#: 36C248-26-AP-5144

DEPARTMENT OF VETERANS AFFAIRS

RESTRICTING COMPETITION USING SIMPLIFIED PROCEDURES

FOR COMMERCIAL ITEMS IN ACCORDANCE WITH RFO 12.102

Acquisition Plan Action ID: 36C248-26-AP-5144

1. Contracting Activity: Department of Veterans Affairs, VISN 8, Network Contracting Office 8, VISN 8

South Team, in support of VA Caribbean Healthcare System (VACHS), located at 10 Casia Street, San Juan, Puerto Rico, 00921.

2. Brief Description of Supplies/Services required and the intended use/estimated amount:

VACHS’s Gastroenterology (GI) Section requires the replacement of three (3) defective artificial-intelligence (AI) endoscopy modules (model CB1708-EU). These units support real-time AI-assisted detection of polyps, lesions, and other colonic abnormalities during colonoscopy procedures. The failure of the existing units directly affects the GI Section’s ability to perform AI-supported screenings and maintain continuity of clinical operations.

To restore capability, VACHS seeks to acquire three (3) Medtronic GI Genius 300 units (model GGM300-US). Medtronic offers an OEM trade-in program that allows VACHS to return the defective CB1708-EU units in exchange for upgraded GGM300-US units at a reduced cost. The trade-in program results in a unit price of , compared to an estimated for purchase without trade-in, providing significant cost savings and ensuring seamless compatibility with the existing Olympus CV-190 EXERA III Imaging System used at the facility.

This requirement will be procured as a Firm-Fixed-Price commercial purchase order under FAR Part 12 procedures.

Estimated total value:

3. Demonstration that the Contractor’s Unique Qualifications:

VACHS requires endoscopy equipment that is fully interoperable with its existing Olympus CV-190 EXERA III Imaging System, which provides the video processing platform for all diagnostic and therapeutic GI procedures performed at the facility. The Medtronic GI Genius 300 (model GGM300-US) is the only FDA-cleared artificial-intelligence (AI) adjunct designed specifically to interface with the CV-190 EXERA III. Its AI algorithms, video-signal processing, system connectors, and real-time detection interface are engineered exclusively by Medtronic for seamless integration with Olympus systems. No other manufacturer produces an AI-based endoscopy module that is compatible with the CV-190 EXERA III or capable of performing real-time polyp detection within VACHS’s established clinical workflow.

In addition to being the sole manufacturer, Medtronic is the only OEM authorized to provide the required trade-in program for the replacement of VACHS’s defective CB1708-EU units. The trade-in program is proprietary and only available directly through Medtronic. This program provides substantial cost savings—reducing the unit price from an estimated per system to per system—while ensuring VACHS receives validated, OEM-certified replacements with full manufacturer support.

The Government’s market research confirmed that no other vendor, distributor, or small business offers an equivalent AI endoscopy product, nor can any third-party supplier provide OEM-authorized GI Genius units with the required trade-in support. The Medtronic GI Genius platform is unique in its:

• Exclusive compatibility with Olympus CV-190 EXERA III systems

• Proprietary AI detection technology used during colonoscopy procedures

• OEM-controlled trade-in replacement program for defective CB1708-EU units

• FDA-cleared configuration and clinical performance characteristics

Given these unique technical, clinical, and OEM-controlled attributes, Medtronic is the only responsible source capable of meeting VACHS’s interoperability requirements, clinical performance standards, and cost-effective replacement needs.

4. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted utilizing multiple methods, including publication of a Sources Sought Notice, direct market surveys, Small Business Administration (SBA) VetCert database reviews, searches of mandatory Government supply sources, and analysis of manufacturer and distributor capabilities under NAICS 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing).

A Sources Sought Notice, posted to Contract Opportunities on 09/08/2026 with a closing date of 09/18/2026, requesting domestic end products and trade-in considerations yielded two responses.

The submission from BHPE, LLC consisted only of a generic email and did not include any of the capability information, technical details, or documentation requested in the notice. As a result, BHPE, LLC could not be considered a capable or responsible source. The second response, submitted by Beacon Point Associates, LLC (SDVOSB), confirmed that they are an authorized distributor for Medtronic/Covidien Sales LLC, however it remains whether they can provide trade-in considerations for defective Medtronic units.

An additional market survey was conducted with Veterans Healthcare Supply Solutions (VHSS). VHSS confirmed, through correspondence from Rich Daege, that they are an SDVOSB distributor of the Medtronic GI Genius 300 and maintain an Electronic Medical Contract with the Defense Logistics Agency (DLA). However, it also remains unknown whether VHSS can provide OEM-supported trade-in considerations for defective Medtronic units.

Further market research across NAICS 334510 identified 14 small businesses, including two SDVOSB/VOSB vendors, none of which offered products compatible with the Medtronic GI Genius Intelligent Endoscopy Module or the existing Olympus CV-190 EXERA III Imaging System installed at the VA Caribbean Healthcare System (VACHS). Searches of ADDS UP-SCMC, ADDS UP Simple Search, NAC MEDSURG, GSA eLibrary, and FPDS confirmed that Medtronic (and its subsidiary Covidien Sales LLC) is the sole OEM source for GI Genius units and the only vendor capable of providing the required OEM trade-in program for replacement of defective CB1708-EU units.

Based on all findings, the required items must be procured as Brand Name Medtronic GI Genius Endoscopy Modules, with trade-in consideration required to return defective CB1708-EU units and acquire upgraded GGM300-US replacements. While VHSS, Inc. and Beacon Point Associates, LLC are verified SDVOSB authorized distributors, market research did not establish sufficient confidence that either vendor can provide OEM-supported trade-in accommodations at a fair and reasonable price.

Medtronic’s San Juan, Puerto Rico office is capable of providing OEM trade-in accommodations and remains the only source with confirmed technical capability and OEM authorization to execute the trade-in requirement.

Market research further confirms that the GI Genius Module is manufactured in Lainate, Italy, and no domestically manufactured equivalents or FDA-approved alternatives exist. Therefore, a Buy American Act (BAA) Nonavailability Waiver is required prior to award.

5. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.