VRNT

VRNT is a prescription-use immersive virtual reality system that delivers cognitive behavioral therapy and evidence-based behavioral methods to patients aged 18 and older with chronic lower back pain (moderate to severe, lasting longer than three months). The device is intended for in-home use over an 8-week program (5 days/week, 40 sessions of 7-27 minutes each) to reduce pain and pain interference.

The subject device (VRNT v2.5) uses Meta Quest 3S VR headset hardware with dual LCD displays (2064×2208 pixels per eye), ~110° horizontal field of view, 6 degrees of freedom, and inside-out optical tracking. The predicate device (VRNT v2.24) used Samsung Gear VRx with a Samsung Galaxy S9. Both use the same therapeutic software content and HTC Vive for onboarding. The hardware differs but provides equivalent functionality, immersion, and performance for therapy delivery.

Risk management activities were conducted in accordance with ISO 14971. Software development followed ISO 13485 clauses 7.3 (design controls), 8.3 (nonconforming product), and 8.5 (corrective and preventative action). Design verification and validation included comprehensive end-to-end functional testing, traceability analysis, anomaly reporting, and hazard analysis for software risks.

The subject device has identical indications for use, intended use, and principles of operation as the predicate device. Both use virtual reality to deliver behavioral-based treatment targeting chronic lower back pain through CBT and evidence-based methods. Although the VR hardware differs (Meta Quest 3S vs. Samsung Gear VRx), each hardware set provides equivalent functionality and immersion necessary for therapy. Design verification and validation testing confirmed all control measures are as effective as the predicate. Therefore, the technological differences do not raise different questions of safety or effectiveness.