Inactive

The Division of Biomedical Physics, Office of Science and Engineering Laboratories (OSEL) at CDRH performs regulatory science research on novel optical diagnostic devices to accelerate patient access ... The Division of Biomedical Physics, Office of Science and Engineering Laboratories (OSEL) at CDRH performs regulatory science research on novel optical diagnostic devices to accelerate patient access to innovative, safe, and effective medical devices. This procurement supports the assembly of a customizable, research-grade Photoacoustic Imaging (PAI) system to support development of regulatory science tools under OSEL's Optical Diagnostics and Therapeutics Program. A high-quality, state-of-the-art PAI system is essential to ensuring our regulatory science efforts are relevant to current PAI-based medical devices and will have maximal impact on affected stakeholders. Scope The procurement supports regulatory science tools development for the Photoacoustic Imaging (PAI) sub-program within the Optical Diagnostics and Therapeutics Program. A modern, high-quality PAI system is essential for regulatory science efforts, including human subjects research, to remain relevant to current generation PAI devices in today's market and those undergoing regulatory evaluation. This equipment will enable completion of research objectives described in OSEL's Medical Imaging and Diagnostics program charter. Requirement Minimum Performance Requirements The vendor shall deliver one (1) Tunable High-Power Laser with the following specifications: Wavelength Specifications Tuning Range: 660 nanometers to 1320 nanometers Step Resolution: 0.1 nanometer Gap Requirement: No large gaps in tuning range permissible Tuning Speed: Wavelength tuning time ? 0.05 seconds for rapid multi-spectral pulse trains Pulse Characteristics Maximum Pulse Energy: ? 150 millijoules (to ensure sufficient photoacoustic image contrast) Pulse Duration: ? 10 nanoseconds (to ensure efficient photoacoustic signal generation) Pulse Repetition Rate: ? 20 Hertz (to achieve necessary high PAI image frame rate) Spectral Linewidth: ? 10 centimeters?¹ (to ensure accurate multispectral scanning and imaging System Configuration Form Factor: Portable, cart-based system with wheels for easy relocation and transport Energy Monitoring: Internal optical energy meter for measuring pulse energy Power Control: Motorized, computer-controllable attenuator for adjusting pulse energy output Output Connectivity: Output ports allowing connection of optical fiber bundles Electronic Interfaces: Electronic connections (e.g., USB 3.0 or BNC) for triggering and digital communication with OEM or third-party hardware/control software Commercial Requirements Pricing and Shipping Bids shall include shipping and handling costs Must include 1-year manufacturer warranty Delivery Requirements Packaging: All deliverables packaged, marked, and shipped per Government specifications Marking: Minimum requirements include contract number and contractor's name Condition: All materials delivered in immediate new, usable, and acceptable condition Deliverable Quantity Delivery Date Tunable High Power Laser 1 ea. 150 days from award INSPECTION/ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement. CONTRACT TYPE This is firm fixed price. PERIOD OF PERFORMANCE 10 September 2025 - 9 February 2025 PLACE OF DELIVERY AND PERFORMANCE FDA/Gulf Coast Seafood Laboratory (GCSL) 1 Iberville Drive Dr. Dauphin Island, AL 36528