SOLOPASS 2.0 System

The SOLOPASS 2.0 System is a neuronavigational tool that uses intraoperative ultrasound imaging and positional tracking to guide surgeons in placing intraventricular catheters in the brain. It consists of a skull-mounted mechanical frame, an ultrasound probe, and a workstation that builds a real-time 3D anatomical model to aid frontal catheter placement without requiring preoperative imaging.

The SOLOPASS 2.0 maintains identical intended use, system components, and operating principles as its predicate device. Key improvements include better targeting accuracy (±2mm vs ±3mm) and imaging accuracy (±1.5mm vs ±2mm). The total ultrasound imaging depth was reduced from 0–10 cm to 0–9 cm to enlarge the useful display area, while the optimal imaging range remains 2.5–8 cm.

ISO 10993-5, 10993-10, 10993-11 (biocompatibility); IEC 60601-1, 60601-1-2, 60601-2-37 (electrical safety and ultrasonic equipment); ASTM F543 (mechanical testing); AAMI/ANSI/ISO 11137-1, 11137-2 (sterilization validation); IEC/EN 60529 (enclosure protection); IEC 62304 (software development).

The subject device performs the same intended function and uses identical operating principles and system architecture as the predicate. Both are ultrasound-guided stereotaxic instruments for intraventricular catheter placement using real-time 2D imaging to build 3D anatomical models. The differences—improved accuracy metrics and slightly reduced imaging depth—represent refinements that do not raise new safety or effectiveness concerns, and all nonclinical testing demonstrates equivalent or superior performance.