SAM #75N98026Q00630

NIH Procurement of CD Leycom INCA Pressure-Volume Loop Systems and Accessories for Clinical Studies

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI) Laboratory of Cardiovascular Intervention, is procuring advanced clinical pressure-volume loop systems for cardiovascular research. - Government Buyer: - National Institutes of Health (NIH), Office of the Director, Office of Logistics and Multiple Acquisition Operations - NHLBI Laboratory of Cardiovascular Intervention - OEM Highlight: - CD Leycom BV is the sole manufacturer of the INCA Pressure-Volume Loop System, the only FDA 510(k)-cleared invasive conductance-catheter-based PV loop system for clinical human use - Products Requested: - 2 x INCA PV Loop Systems (part number: 3001880), each including hardware, touchscreen medical PC, and ConductNT analysis software - 2 x Trolley carts for INCA systems (part number: 4100189) - 2 x Pressure-arm catheter cables (0.5 m, part number: 410019302) - 2 x Volume-arm catheter cables (2.7 m, part number: 410019401) - 20 x Disposable PV loop catheters (0.025-inch lumen, 12 electrodes, 8 mm spacing, part number: CA-710837F 4100079) - Services Requested: - 2 x Platinum Clinical Applications Training & Support packages (part number: 9900012), including three days onsite installation/training and 8 hours remote support - Notable Requirements: - Systems must be FDA 510(k) cleared for clinical human use - Delivery required to two medical centers - Brand-name only procurement due to unique clinical and regulatory requirements - Supports SESAME clinical studies under Investigational Device Exemption (IDE) G220158

Description

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.(ii) The solicitation number is 75N98026Q00630. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a purchase order without providing for full and open competition (brand-name).This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to CD Leycom BV, Asveldweg 2, 7556 BP Hengelo, The Netherlands (U.S. point of contact: Patrick Sullivan, +1 (817) 879-9670; SAM.gov UEI: JLLJMU81NKV4), for two (2) complete CD Leycom INCA Pressure-Volume (PV) Loop Systems with associated accessories, disposable 7F PV loop catheters, and Platinum-level training and support, in support of the National Heart, Lung, and Blood Institute (NHLBI) Laboratory of Cardiovascular Intervention (LCI) SESAME clinical studies conducted under Investigational Device Exemption (IDE) G220158. CD Leycom BV is the sole commercial manufacturer worldwide of an invasive conductance-catheter-based pressure-volume loop recording system holding FDA 510(k) market clearance for use in human patients; no other vendor offers an equivalent system approved for clinical human use.(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective March 13, 2026.(iv) The associated NAICS code is 334516 ¿ Analytical Laboratory Instrument Manufacturing, and the small business size standard is 1,000 employees. This requirement is not set aside for small business.

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