6515--Exalt Controller Processor

Page 1 of Page 1 of Page 1 of Page 1 of This is not a solicitation but rather a Request for Information (RFI/Sources Sought) for market research purposes only. Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 5, is issuing this Sources Sought in order to identify capable firms and obtain information for planning purposes only. Responses must be submitted by 3:00 PM EST, July 17th 2026. Submit responses to this Sources Sought via email to james.ferro@va.gov All SDVOSB and VOSB firms that respond shall include proof of SBA certification via https://veterans.certify.sba.gov/All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with (FAR 4.1102 Policy). While SDVOSB/VOSB firms are preferred, all capable firms are welcome to respond to this Sources Sought. All respondents to this Sources Sought shall include as part of their response answers to the below questions and provide any additional pertinent information that supports the answers. If there are any ambiguities in this Sources Sought, please identify them in your response. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Suggested NAICS: 339112 Surgical and Medical Instrument Manufacturing Suggested PSC: 6515 Medical and Surgical Instruments, Equipment, and Supplies Open to suggestions from the market as to a more proper NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories. Product ID# Product Description Quantity M00542430 EXALT Model D Controller 12 Month Lease Service/Maintenance 1 Year Statement of Work Exalt disposable duodenoscope processor for the disposable single use duodenoscope generation 4 Purpose Replacement of standard Olympus duodenoscope with disposable single use duodenoscope that requires the duodenoscope processor: EXALT Controller Background Duodenoscope used in ERCP carry a significant infection risk due to there complex design, particularly the elevator mechanism, which is difficult to clean and disinfect. On December 10, 2018 the U.S. Food & Drug Administration (FDA) released interim results from post-market surveillance studies on contamination rates with duodenoscopes after reprocessing. FDA has issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure, and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa. The FDA recommends facilities and staff strictly adhere to the manufacturer s reprocessing and maintenance instructions, and follow these best practices: Recent evidence indicates infections rates are substantially higher than previously recognized, with persistent contamination. There has been a sharp increase in global reporting of duodenoscope-related infectious outbreaks, with the majority unrelated to identifiable breaches in disinfection protocols. This has led experts to question the design of the standard duodenoscope. In the Netherlands, a recent nationwide study found that 22% of duodenoscopes were persistently contaminated after high-level disinfection Exalt single use duodenoscope eliminates the risk of patient of patient infection due to ineffective reprocessing while also eliminates the reprocessing cost. The single use duodenoscope also delivers consistence performance the endoscopist expect from duodenoscope. Objectives The objective is to replaced the standard ERCP duodenoscope to disposable duodenoscopes from Boston Scientific which uses a processor for the images called the EXALT Controller. Product Descriptions Scope Specifications Specification Value Retro viewing angle (o) 5 Field of view (o) 108 Depth of field (mm) 5-60 Distal end outer diameter (mm) 15.1 Insertion tube outer diameter (mm) 11.3 Working length (mm) 1240 Working channel inner diameter (mm) 4.2 Angulation range Up (o) 120 Angulation range Down (o) 90 Angulation range Right (o) 110 Angulation range Left (o) 90   Ordering Information UPN Item Description Packaging M00542420 EXALT Model D Single-Use Duodenoscope Sterile Single-Use Duodenoscope for use with EXALT Controller Box 1 M00542421 EXALT Model D Single-Use Duodenoscope Sterile Single-Use Duodenoscope for use with EXALT Controller Box 2 M00542423 EXALT Model D Single-Use Duodenoscope Sterile Single-Use Duodenoscope for use with EXALT Controller Box 4 M00542424 EXALT Model D Single-Use Duodenoscope Sterile Single-Use Duodenoscope for use with EXALT Controller Box 8 M00542430 EXALT Controller 100-240 VAC Controller for use with single-use duodenoscope (including detachable power cable, DVI and HDMI cables) Box 1 Period of Performance Starting as soon as the single use duodenoscope processor EXALT controller is approved. Place of Performance Endoscopy unit Baltimore VA If you are interested, please e-mail the following information: Company Name: UEI Number: Cage Code: Dun & Bradstreet Number: Person of Contact (including telephone number and email address). Socio-economic status (SDVOSB, VOSB, Woman-Owned, Other etc.). Are you a distributor or a manufacturer? If you are an authorized distributor, please provide confirmation on Company Letter Head. If you are a distributor, who is the manufacturer? Where is the manufacturer located in the world? Do you currently hold a government contract? Contract Number? Type of contract? Are these particular quoted items under contract? With whom (GSA, SEWP, etc )? If GSA what Schedule and SIN? Can your company provide the service for the listed Department of Veterans Affairs locations? Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 5 of 5 Page 5 of 5 Page 1 of 2 Page 1 of Page 1 of Page 1 of Page 1 of Does your firm utilize the suggested NAICS and PSC per this Sources Sought Notice? If not, please suggest a more appropriate NAICS and/or PSC and explain why it s more appropriate? How do you invoice for this service, including rates? What Certifications, State and/or Federal, if any must you have to perform this service? Please list all of your concerns, questions and ambiguities below. Questions will not be addressed directly but will be used by the Government in the event that this Sources Sought would move forward to solicitation. Please provide estimated rates if possible.