HyperSnap Surgical System (HSS)

The HyperSnap Surgical System (HSS) is a real-time hyperspectral imaging camera system for intraoperative use that displays standard RGB video alongside tissue oxygen saturation (StO2) information. It serves as an adjunctive monitor to help identify patients at risk of tissue ischemia during open and minimally invasive general surgical procedures using compatible surgical telescopes.

The subject device uses snapshot hyperspectral imaging with a mosaic CMOS sensor and deep learning algorithms to reconstruct spatio-spectral information and estimate StO2 in real-time. In contrast, the predicate (FUJIFILM EX-0, VP-7000) uses selective LED wavelength illumination with an RGB charge-coupled device at the endoscope tip and nonlinear image transformation to quantify StO2, and also provides additional imaging modes (FICE, BLI, LCI) not present in the subject device.

IEC 62304 (software), ISO 14971 (risk management), TIR 57 (cybersecurity), IEC 62366-1 (usability), IEC 62471 (photobiological safety), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 (electrical safety), AIM 7351731 (EMC), ISO 8600-5 and ISO 12233 (spatial resolution).

Both devices provide real-time intraoperative imaging for surgeons to assess vessels and tissue viability, both relay tissue oxygenation metrics (StO2) of superficial tissue in patients at risk of ischemia, and both are Class II devices under 21 CFR 876.1500. Although the subject device employs hyperspectral rather than multi-wavelength LED technology, bench testing with 12 blood-based phantoms and three GLP animal studies demonstrated that the subject device's StO2 measurement performance is comparable to the reference device, with successful detection of qualitative and quantitative StO2 changes and adequate RGB visualization, establishing that differences in imaging approach raise no new safety or efficacy concerns.