cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

The cCeLL - In vivo with Drop-In Robo is a confocal laser imaging system with fiber optic probes designed to visualize internal tissue microstructure, including cells, vessels, and blood flow during endoscopic and laparoscopic surgical procedures, including robot-assisted surgery. It uses indocyanine green (ICG) fluorescence to perform angiography and assess tissue perfusion.

The device operates at 775 nm excitation wavelength with 813-850 nm detection bandwidth, achieves 44.6 μm depth of observation, 500 μm × 500 μm field of view, 2.19 μm lateral resolution, and up to 3.5 mW fluorescence excitation power. The key modification from the reference device is the Drop-In Robo probe configured for robotic instrument compatibility via drop-in design, while maintaining identical optical, electronic, and mechanical core components in the Main Unit.

IEC 60601-1:2005/AMD2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), ISO 13485 (design controls and quality management), ISO 11135:2014+Amd1:2018 (sterilization by ethylene oxide), ISO 11737-1 and ISO 11737-2 (microbiological methods), and ISO 10993-1 (biocompatibility evaluation).

The subject device shares the same component design, fundamental confocal technology, and operating principle as the previously cleared reference device cCeLL - In vivo (K233391). The only modification is the Drop-In Robo probe for robotic compatibility; no changes were made to the Main Unit's core optical, electronic, or mechanical components. Performance testing demonstrates equivalent or superior image quality, optical linearity, uniformity, and robotic compatibility compared to predicate devices, establishing substantial equivalence without raising new safety or effectiveness concerns.