IDENTIFY (5.0)

IDENTIFY 5.0 is a surface guidance radiotherapy (SGRT) system that uses high-precision cameras to monitor patient motion during radiation therapy treatment simulation and delivery. It positions patients, monitors their motion including respiratory patterns, and outputs data to radiotherapy devices to synchronize imaging or treatment delivery with patient motion information.

IDENTIFY 5.0 adds several new features to the predicate device (IDENTIFY 4.0): auto-capture of reference surface at start of CBCT imaging, automated MV beam-hold, sending couch shifts to treatment console, auto-alignment of reference surface with couch movements, and automated kV beam-hold during imaging. These features enable integration with Varian Halcyon and Ethos Radiotherapy Systems via ADI+ interface, whereas the predicate was standalone only.

Testing was performed to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 14971 (risk management), ISO 13485 (QMS), IEC 62304 (software lifecycle), IEC 62366-1 (usability), and IEC 61217 (radiation therapy coordinate systems), among others listed in Table 2.

The intended use and indications for use are identical to the predicate device with no change to the principle of operation. The new technological features are substantially similar functionality enhancements that enable additional delivery system integrations without raising new safety or effectiveness questions. Verification, validation, and conformance to relevant safety standards demonstrate the device meets safety and performance criteria equivalent to the predicate.