The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.106-1(b)(1) soliciting from a single source. The proposed manufacturer is Pentax of America, Inc. (Pentax) of 3 Paragon Drive, Montvale, NJ 07645. The requirement is for one (1) video system, endoscopic [15-967] for Naval Medical Center San Diego (NMCSD). The transnasal esophageal (TNE) equipment shall be capable of examining the esophagus, diagnosing esophageal cancer, diagnosing other medical conditions (e.g. dysphagia, Barrett's esophagus), and capturing video-picture images during TNE procedures. The TNE equipment shall be compatible and utilized in conjunction with the existing flexible laryngoscopes utilized for stroboscopic and transnasal examinations. Additionally, the TNE equipment shall be comprised of the following units: TNE Unit Requirements High Definition (HD) Camera Zoom Coupler HD Digital Video Capture HD Video Processor Cart 24" LED Monitor HD Foot Switch Assembly Configuration and Training TNE Software for Stroboscopy and Swallow Station Isolation Transformer 100/120/220V All of the units listed above shall be compatible with the stroboscopy and transnasal flexible endoscopes in Pentax Medical Stroboscopy and Swallow Stations of the Otolaryngology department at NMCSD. In addition, the isolation transformer shall be integrated in the cart for equipment safety. The power requirements are 120 VAC, 60 Hz. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334510. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at
contact@example.gov. Closing date for challenges is no later than 9:00 AM ET on 20 February 2018. No phone calls will be accepted.