Klarity SGRT System (ARSG-E1A, ARSG-E3A)

The Klarity SGRT System is a non-irradiating, non-invasive surface-guided radiation therapy device used alongside linear accelerators and CT simulators. It performs real-time patient positioning, continuous motion monitoring during treatment, and respiratory gating to synchronize imaging and radiation delivery with the patient's breathing patterns.

The device uses optical triangulation with structured visible light patterns (LED at 465nm wavelength) and digital cameras to measure patient surface position with accuracy better than 1mm. It includes advanced software, a PC workstation, and one to three 3D cameras. Key differences from the predicate include a Class I laser classification (versus Class II) and different power specifications, but similar core measurement technology and performance specifications.

IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-8 (alarm systems), IEC 62471 (photobiological safety), IEC 60825-1 (laser safety), ISO 10993-1 (biocompatibility), IEC 60601-1-6 (usability), and FDA guidance documents on software and cybersecurity in medical devices (2023).

The Klarity SGRT System is substantially equivalent to the predicate Catalyst because both devices use identical optical triangulation technology with structured visible light patterns to achieve the same intended functions: patient positioning, motion monitoring, and respiratory gating in radiation therapy. Performance specifications (measurement accuracy ≤1mm, respiratory gating accuracy ≤1mm) and intended use are equivalent. Noted differences (laser classification, power source, scan volume) do not raise safety or effectiveness concerns and reflect design variations rather than fundamental functional differences.