Endoscopy Systems
Under FDA guidance, this OSEL-DIDSR collaboration seeks an endoscope system to expand scientific research capacity and support development of bench testing methods for evaluating endoscopy device safety and effectiveness. The Government requires a fully interoperable endoscopy system including a video processor, colonoscope, medical display, and cart that can acquire and display live images. Key requirements include an FDA-cleared 510(k) video processor with integrated LED light source, white light, two or more NBI modes, two or more FDA-cleared PEA digital color enhancement modes, specified SDI video outputs, and still/video capture; an FDA-cleared 510(k) forward-viewing colonoscope with 170° or wider field of view, 5–100 mm or wider depth of field, specified angulation, water nozzle, =12.8 mm insertion tube, and =3.7 mm instrument channel; and a =32-inch 4K medical display with specified inputs. The system must be shipped to the US FDA in Silver Spring, MD 20993, with shipping cost included in the total purchase price, and all components must operate on standard U.S. 120V/60Hz AC power. The contractor must deliver within six weeks of contract award and provide at least a one-year total system warranty, including parts, labor, travel, and shipping, with a one-year warranty period following system acceptance.