36C25026P0866 Manometry Probes SPS - Cincinnati PO 539A60196

DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold Acquisition Plan Action ID:

36C250-26-AP-2650 Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Cincinnati VA Medical Center (VAMC), 3200 Vine Street, Cincinnati, OH 45220-2213.

2237 #: 539-26-2-043-0148 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Clinicians in the Speech and Endoscopy clinics at CVAMC operates Government owned high-resolution manometry (HRM) systems to perform diagnostic esophageal motility studies to determine the root cause of symptoms, diagnose esophageal disorders and personalize their approach to manage the care of esophageal patients.

The manometry probe (or catheter) required to operate the HRM system is a thin, flexible tube equipped with sensors, inserted through the nose or mouth into the gastrointestinal tract to measure muscle pressure and coordination. This new request is for a one-time firm-fixed-price contract to procure replacement manometry probes compatible with the HRM system that are at end of lifecycle. The supplies/services needed are:

Manoscan ESO Z CATH X1 – Mfr.

Part #: 3890 – Quantity of 4 Each HRM Catheter Extended WARRANTY 1 YEAR – Mfr.

Part #: 80372 – Quantity of 4 Each Shipping and Handling (Estimated) – Quantity of 1 Each Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The ManoView manometry system is a proprietary platform that requires OEM manufactured ManoScan catheters for operation. These catheters utilize proprietary connectors, hardware interfaces, and system recognition features that are unique to Medtronic equipment.

The HRM system requires OEM-compatible manometry probes to avoid calibration drift, invalid pressure profiles, and adverse impact on clinical decisions. Probes from non?OEM sources are not validated with this system’s firmware and sterile pathway, creating risk to patient safety and data integrity. Medical device accessories must be assessed in context of the parent device; compatibility and risk controls apply.

The equipment must meet the following minimum salient characteristics: Sensor & Catheter Specifications This section is intentionally left blank. Coverage & Mapping Capabilities This section is intentionally left blank. Diagnostic Enhancements This section is intentionally left blank. Software Functions This section is intentionally left blank. Efficiency & Training This section is intentionally left blank.

Description of market research conducted and results or statement why it was not conducted: The CVAMC SPS initiated market research in December 2025 to determine the facility’s needs and market availability. The LB OEM provided an informal quote and none of the items were found to be offered on FSS contract. Additional market queries were conducted by the Contracting Specialist using SBA SBS, SAM.gov, GSA Advantage, VA NAC, and ADDS UP databases.

There were multiple entries found for various types of catheters offered by others in the industry. None of those items are compatible with the Government owned HRM equipment at the facility and capable of meeting this requirement. The product NAICS code was not found in the NMR class waiver database. Direct contact was made with the LB OEM. The OEM confirmed the country of orgin (COO) for the equipment is Vietnam and that pricing is open market.

They also identified three (3) SBA SBS verified SDVOSB authorized distributors. Due to the NMR findings, an SDVOSB, VOSB set-aside is prohibited. The VA and Rule of Two cannot be met. The SBA Rule of Two is obtainable. A small business set-aside solicitation for brand name equipment will be posted to the Governmentwide point of entry (GPE) to obtain fair and reasonable pricing.