CVAC Image Processor

The CVAC Image Processor is a reusable, software-controlled electrical image processor that works with the CVAC Aspiration System to help physicians locate and treat kidney stones during endoscopic urological procedures. It connects to standard hospital monitors and provides video imaging of the urinary tract and kidney interior to guide stone removal and fragmentation.

The subject device features software updated to version 1.5 with improved system performance, cybersecurity upgrades, enhanced image processing with better noise reduction and brightness uniformity, and added error handling and failover mechanisms for reliability. Minor hardware modifications include logo updates and improved electromechanical robustness. Optical parameters remain identical to the predicate: 200x200 pixel resolution, color CMOS technology, LED illumination, 120° field of view, and ~5500 lux at 6mm.

ISO 62304 (software lifecycle), ISO 62471, ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-6 (optical testing), IEC 62304, ISO 13485 (quality management), and FDA guidance documents on device software functions and cybersecurity in medical devices.

The CVAC Image Processor with software v1.5 is substantially equivalent to the predicate (K233472) because it maintains identical intended use, indications, and optical performance characteristics while implementing improvements that do not raise new safety or effectiveness questions. Software and cybersecurity testing passed, optical testing showed no clinically relevant differences, and an in vivo validation study confirmed the device meets specifications and design requirements.