Endoscopy Systems

Inactive
Notice ID:75F40126Q00381

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.

Department/Ind.Agency Subtier Office
HEALTH AND HUMAN SERVICES, DEPARTMENT OF FOOD AND DRUG ADMINISTRATION FDA OFFICE OF ACQ GRANT SVCS
  PSC   LABORATORY EQUIPMENT AND SUPPLIES
LOCATION: Not Given
Primary Contact
Pamela T. Lee
240-***-3847
Alt Contact
Madeline Bryant
240-***-7611


Data sourced from SAM.gov. View Official Posting »

Endoscopy Systems

Notice ID:75F40126Q00381

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.

Department/Ind.Agency Subtier Office
HEALTH AND HUMAN SERVICES, DEPARTMENT OF FOOD AND DRUG ADMINISTRATION FDA OFFICE OF ACQ GRANT SVCS
  PSC   6640 LABORATORY EQUIPMENT AND SUPPLIES
LOCATION: Not Given
Primary Contact
Pamela T. Lee
240-***-3847
Alt Contact
Madeline Bryant
240-***-7611

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Data sourced from SAM.gov. View Official Posting »