Dendrite Imaging System

The Dendrite Imaging System is a handheld fluorescence imaging device that captures real-time images of nerve tissue during open surgical procedures. It uses near-ultraviolet LED light to excite the natural autofluorescence in nerves, allowing surgeons to visualize and locate nerves as an adjunct to visual assessment, but not as a replacement for experienced surgical judgment.

The device uses a 385 nm LED light source (vs. the predicate's 750 nm laser), a monochromatic CMOS sensor (vs. CCD), and has a working distance of 30-34 cm with 150 µm resolution and 14 frames/sec frame rate. It generates less than 1 W of light output compared to the predicate's 5.0 ± 0.5 mW/cm² laser power density, and uses a single integrated control display rather than a separate control box.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62471 (light safety), IEC 62304 (software lifecycle), ISTA-3A (packaging validation), and GLP compliance (21 CFR Part 58) for animal testing.

Both devices operate on the same autofluorescence imaging principle to detect tissue by emitting light of specific wavelengths and capturing the resulting fluorescence. Although the subject device uses LED light at 385 nm rather than 750 nm laser light, comprehensive bench testing, animal testing (95% sensitivity, 100% positive predictive value for nerve detection), and clinical testing (23 patients, 49 nerves, no adverse events) demonstrate equivalent or superior safety and effectiveness with no new risks identified.