NOI - PCA-NHLBI-07088
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, is issuing a non-competitive combined synopsis/solicitation under solicitation number 75N98026Q00630 to procure two complete CD Leycom INCA Pressure-Volume Loop Systems along with associated accessories, disposable catheters, and platinum-level training and support. This procurement supports clinical studies conducted by the National Heart, Lung, and Blood Institute’s Laboratory of Cardiovascular Intervention under an Investigational Device Exemption. The purchase will be awarded as a firm-fixed-price order to CD Leycom BV, the sole worldwide manufacturer of this invasive conductance-catheter-based system, which holds FDA 510(k) market clearance for clinical use in human patients. Due to the unique capabilities of CD Leycom’s system and its regulatory approval status, no other vendor can provide an equivalent product, justifying the non-competitive acquisition approach. This acquisition is conducted under FAR Part 12.603 for streamlined solicitation of commercial products and services and falls below the simplified acquisition threshold. It is issued as a Notice of Intent without plans for full and open competition, referencing authorities including FAR 6.302-3(a)(2)(ii) and 41 U.S.C. 1901. The applicable NAICS code is 334516, Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1,000 employees; however, this requirement is not set aside for small businesses. The solicitation incorporates provisions effective as of March 13, 2026, per the latest Federal Acquisition Circular. The response deadline is set for June 23, 2026, with point of contact information provided for coordination.
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Documents
(1)AI Contract Breakdown
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Full Description
(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.