Requirements Document- Visible range spectrometer - Final SAM.docx

Requirements Document

1. Background and Purpose The FDA Center for Devices and Radiological Health (CDRH) requires a specialized visible range spectrometer with one (1) megahertz (MHz) line scan camera to support the agency's mission of protecting and promoting public health through ensuring the safety and effectiveness of emerging medical devices.

This procurement directly supports FDA/CDRH's Ophthalmic Devices program in developing critical regulatory science capabilities for evidence-based evaluation of visible light optical coherence tomography (OCT) technology as it advances toward clinical adoption. The establishment of an in-house visible light OCT imaging test bed will enhance CDRH's ability to understand emerging ophthalmic imaging technologies and enable more informed, scientifically rigorous review processes.

2. Scope and Objectives The required specialized visible range spectrometer shall enable development of a visible light OCT ophthalmic imaging device for:

• Clinical evidence development - Supporting the creation of evidence-based evaluation methods for retinal oximetry and establishing validated retinal phantoms

• Biomarker research - Developing retinal disease-specific biomarkers through precise imaging capabilities

• Regulatory science advancement - Creating and disseminating regulatory science tools for public use

• Technology assessment - Proactively addressing regulatory science gaps in emerging ophthalmic imaging technologies

3. Technical Requirements The required specialized visible range spectrometer shall have all the following minimum requirements:

3.1 Spectrometer and Imaging System Specifications

The visible light detection component shall include an integrated spectrometer, camera, and frame grabbers meeting the following specifications:

Optical Performance: • Wavelength range: 450nm - 750nm

• Imaging depth: ≥ 3.5mm (in air)

• Bandwidth tolerance: ≤ +/- 15nm

• Spectral resolution: ≤ 0.04nm Camera Requirements:

• Camera type: Line scan TDI (Time Delay Integration)

• Camera resolution: ≥ 16384 x 288 pixels

• Camera pixel size: ≤ 5 x 5µm

• Camera dynamic range: ≥ 65dB

• Camera line rate: >800 kHz with 10-bit depth

• Maximum camera line rate: 1MHz

• Camera quantum efficiency: ≥ 95%

• Camera data format: 8 or 10 bit

• Camera read noise: ≤ 20 e-

• Camera interface: Active Optical Connector (AOC) compatible

• Illumination area on camera: ≥ 8k pixels (maximum 16k pixels) Frame Grabber Specifications:

• Frame grabbers: PCI Express Gen3 x8 slot compatible

• Frame grabber acquisition rate: ≥ 7 GB/s

• Frame grabber host transfer rate: ≥ 6.8GB/s

• Frame grabber feature: Image cropping capability

• Frame grabber pixel format: Mono8, Mono10, Mono12 and Mono16

• Frame grabber connector: AOC compatible

• On board memory: ≥ 512 MB per frame grabber

3.2 Software Requirements

Licensing and Compatibility:

• Permanent software license required

• Software Development Kit (SDK) with drivers or ActiveX support for controlling camera with third-party software including LabVIEW, MATLAB, Visual Basic, or Python

• Compatible with Windows 10 Operating System

3.3 Integration and Support Requirements

System Integration:

• Complete integration of all components including power supply, AOC cables, testing, alignment, and calibration

• All shipping and handling costs included

• User manual containing detailed instructions for use and performance specifications Support Services:

• Technical support available during normal business hours

• No training required

• No installation required Warranty and quality assurance provisions:

The Contractor shall provide a minimum one (1) year warranty from date of Government acceptance of the specialized visible range spectrometer. The Contractor shall guarantee full device replacement at no additional cost to the Government for any manufacturing defects or operational failures during normal use as defined in the user manual. Warranty coverage shall include all associated shipping costs for replacement units.

4. Delivery Requirements

4.1 Timeline and Condition

• Delivery shall be completed within 60 days of contract award

• All deliverables shall be delivered in immediate new, usable, and acceptable condition

4.2 Packaging and Marking

All deliverables shall be:

• Packaged, marked, and shipped in accordance with Government specifications

• Marked with contract number and Contractor's name at minimum

4.3 Delivery Address

Ship to: US FDA CDRH DBP 10903 New Hampshire Avenue

WO62 RM 1132

Silver Spring, Maryland 20993

5. Performance Standards The required specialized visible range spectrometer shall meet all specified technical requirements and performance standards as outlined in Section 3. The Contractor shall guarantee that all materials meet the stated specifications and operate within the defined parameters for intended regulatory science applications.