Endoscopy Systems
The FDA/OSEL-DIDSR collaboration requires a complete endoscopy system—video processor, colonoscope, medical display, and cart—that is interoperable and supports live image acquisition/display for bench testing methods. The video processor must be an FDA-cleared 510(k) device with integrated LED light source, white light, at least two NBI modes, at least two digital color enhancement modes FDA-cleared under product code PEA, specified 12G/3G/HD-SDI outputs, and still/video capture. The colonoscope must be FDA-cleared 510(k), forward-viewing, with =170° field of view, 5–100 mm depth of field, specified angulation, water nozzle, =12.8 mm insertion tube, and =3.7 mm instrument channel; the 4K display must be =32 inches with listed inputs. Delivery is required within six weeks of contract award to the FDA in Silver Spring, MD, with shipping included in the total purchase price, and the system must include a one-year total warranty plus a one-year warranty following system acceptance. All components must operate on standard U.S. 120 V/60 Hz power.