Dendrite Imaging System
Dendrite Imaging, Inc.The Dendrite Imaging System is a handheld device used during surgery to capture and display autofluorescent images of nerves in real time. It helps surgeons locate nerve tissue by illuminating tissue with near ultraviolet light, which causes nerves to fluoresce naturally. The images are captured by a camera and displayed on a touchscreen, assisting surgeons to better identify and preserve nerves during procedures without replacing visual assessment.
Intended Use
The Dendrite Imaging System is indicated for use in real-time capturing and viewing of autofluorescent images of nerves and can be used as an adjunctive method to assist in the location of nerves during surgery. Use of the device is intended to assist, not replace, experienced visual assessment. The system is not to be used to confirm the absence of nerve tissue and is only to be used to assist in locating visually identified nerves.
Technology
The system uses near ultraviolet LED light at 385 nm to excite nerve tissue's natural autofluorescence around 450 nm, captured by a monochromatic CMOS camera inside a handheld unit. White LED provides visible illumination. The camera transmits digital video signals to a control display with touchscreen interface for image viewing and adjustment. Images and video can be saved and exported via USB. The device runs software following IEC 62304 standards and includes electrical safety, EMC, and light safety features.
Performance
Performance testing included bench testing for image quality, light safety, electrical safety, electromagnetic compatibility, software verification, cybersecurity testing, packaging validation, and functional verification. Animal testing in guinea pigs showed 95% sensitivity and 100% positive predictive value for nerve fluorescence without device-related adverse events. Clinical testing in 23 subjects demonstrated effective nerve imaging across multiple nerve types without adverse events, supporting safe and effective use as intended.
Predicate Devices
No predicate devices specified
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