SAM #75F40126Q00381

FDA Solicits Complete Endoscopy System for Scientific Research

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH) and Office of Science and Engineering Laboratories (OSEL), is seeking to procure a complete endoscopy system for scientific research purposes. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Science and Engineering Laboratories (OSEL) - Products/Services Requested: - One endoscopy system, including: - FDA-cleared video processor with integrated LED light source - Must support white light mode, multiple narrow-band imaging modes, digital color enhancement modes, and specified video output ports - FDA-cleared colonoscope - Forward viewing, wide field of view, depth of field, angulation, water nozzle, insertion tube diameter, and instrument channel diameter - Medical display (minimum 32-inch, 4K resolution, at least 3840x2160 pixels) - Must support multiple signal inputs - Cart - All components must be interoperable and capable of live image acquisition and display - Unique/Notable Requirements: - All medical devices must be FDA-cleared (510(k)) - System must operate as a fully functional unit - Powered by standard U.S. AC power - One-year warranty covering parts, labor, travel, and shipping - Shipping and handling costs must be included in the firm-fixed price quote - Delivery required within six weeks of contract award - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Technical specifications are detailed for each component, emphasizing interoperability and FDA clearance.

Description

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:

Attention to: TBD

10903 New Hampshire Ave WO62-3133, US FDA

Silver Spring, MD 20993-

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.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.

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