Adaptive Optics (AO) Retinal Imaging System

Background
The U.S. Food and Drug Administration (FDA) is seeking to acquire an Adaptive Optics (AO) Retinal Imaging System to support its mission of fostering and accelerating the clinical translation of innovative medical device technologies. This acquisition is crucial for evaluating and validating emerging retinal imaging technologies, developing regulatory science tools, and facilitating the assessment of novel biomarkers for future medical device applications.

The system will be deployed in the Optical Diagnostic Devices Laboratory of FDA/CDRH/OSEL/DBP to support ongoing studies under the ophthalmic devices program charter, particularly in characterizing performance and capabilities of optical diagnostic devices for retinal diseases.

Work Details
The contract involves the procurement of an Adaptive Optics (AO) Retinal Imaging System, which includes both hardware and software components. The system must meet the following salient characteristics:
- **Hardware Specifications:**
- Methodology: Pupillary reflectance imaging and non-contact transscleral flood illumination
- Light sources: Infrared LED and SLD (750 to 890 nm)
- Lateral resolution in tissue (optical): 2 — 3 µm
- Pixel pitch: 1 µm
- Focusing range in tissue: 300 µm
- Cellular View image field angle: >6.5° x 6.5°
- Fundus Overview image field angle: 30° x 30°
- Minimum pupil diameter: 4 mm
- Refractive error adjustment: +15 D to –15 D, continuous
- Acquisition time: <3 seconds
- Fixation targets: Internal and external
- **Software Requirements:**
- Simultaneous live widefield overview and cellular-level imaging
- Pupil alignment feedback
- Image comparison for follow-up examination
- **Electronic Interfaces:**
- Input voltage and frequency: 100 — 240 V, 50 — 60 Hz
- Power consumption (max): 450 W
- Dimensions (L x W x H): <= 65cm x 65cm x 65cm
- Weight: <= 60 kg

Place of Performance
Deliverables are to be sent to the U.S. Food and Drug Administration, CDRH/OSEL/DBP, located at 10903 New Hampshire Avenue, WO62 Room 1124, Silver Spring, MD.