Requirements Document sam.docx

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Requirements Document 08/20/2025

Background The Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable. Additionally, FDA helps the public get accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products under FDA oversight. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Office of Science and Engineering Laboratories (OSEL) supports the CDRH mission of protecting and promoting public health. OSEL undertakes the highest quality science to provide its customers with the best methods, tools and expertise to:

· Ensure readiness for emerging and innovative medical technologies

· Develop appropriate evaluation strategies and testing standards

· Create accessible and understandable public health information and,

· Deliver timely and accurate decisions for products across their life cycle.

Through a culture of customer first, communication, collaboration and consultancy, the Division of Imaging, Diagnostics and Software Reliability (DIDSR) participates in the CDRH mission of protecting and promoting public health by identifying and investigating issues related to medical imaging, computer-assisted diagnostics, and software reliability. DIDSR accomplishes this through activities supporting the OSEL mission.

Objectives Under FDA guidance, this OSEL-DIDSR collaboration requires an endoscope to maximize scientific research capacity throughout the center and agency. An endoscope allows OSEL researchers to develop bench testing methods for evaluating the safety and effectiveness of endoscopy devices.

The Government requires an endoscope system (Endoscope) with the following minimum requirements:

· The Endoscope shall be shipped to the following address:

10903 New Hampshire Ave

WO62-3133, US FDA

Silver Spring, MD 20993-0002

· Shipping cost is included in the total purchase price.

· The Endoscope shall include the video processor, colonoscope, medical display, and cart that are interoperable with each other. Once assembled, these components shall operate as a fully functional endoscopy system that can acquire and display live image.

· The video processor shall satisfy the following requirements:

· The video processor shall be an FDA-cleared 510(k) medical device. The database is publicly available at 510(k) Premarket Notification.

· The light source shall be integrated within the video processor.

· The light source shall use three (3) or more LEDs to synthesize different spectra.

· The video processor shall have the white light mode.

· The video processor shall have two (2) or more narrow-band imaging (NBI) modes that utilize different optical spectra generated by the LED-based light source. The NBI modes shall be FDA-cleared for visualizing biological features such as blood vessels or mucosal surfaces.

· The video processor shall have two (2) or more digital color enhancement modes that utilize different digital image processing techniques. These color enhancement modes shall be FDA-cleared under the FDA product code “PEA”.

· The video processor shall have the following video output ports and video formats:

· 12G-SDI (3840x2160x60p)

· 3G-SDI (1920x1080x60p)

· HD-SDI (1900x1080x60i)

· The video processor shall have the capability of saving still images in a standard image file format such as TIFF or JPEG.

· The video processor shall have the capability of saving video clips in a standard video file format.

· The colonoscope shall satisfy the following requirements:

· The colonoscope shall be an FDA-cleared 510(k) colonoscope device.

· The direction of view shall be forward viewing.

· The field of view shall be 170 ° or wider.

· The depth of field shall cover the range of 5-100 mm or wider.

· The angulation (up/down/right/left) shall be 180°/180°/160°/160° or larger.

· The colonoscope shall have a water nozzle.

· The insertion tube diameter shall be 12.8 mm or smaller.

· The colonoscope shall have an instrument channel with diameter of 3.7 mm or larger.

· The medical display shall satisfy the following requirements:

· The signal input ports shall include:

· 12G-SDI

· 3G-SDI

· Display Port

· HDMI

· DVI

· The pixel count shall be equal to or greater than 3840x2160 pixels (4K).

· The display size (diagonal) shall be equal to or greater than 32 inches.

· All components in the system shall be powered by the standard 120 volts, 60 Hertz alternating current power in the U.S.

· The Endoscope shall include a total system warranty for at least one (1) year, inclusive of any parts, labor, travel, and shipping cost to return the system to the original equipment manufacturer (OEM) standards.

Delivery The Contractor shall deliver the endoscope system to FDA. The shipping information is as follows:

10903 New Hampshire Ave

WO62-3133, US FDA

Silver Spring, MD 20993-0002

Period of Performance The Contractor shall deliver the endoscope within six (6) weeks of contract award. The Contractor shall provide a one (1)-year warranty period following system acceptance.