INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

The INTRABEAM 700 is an intraoperative X-ray radiation therapy system designed to deliver low-energy radiation (up to 50 keV) to tumors or tumor beds during minimally invasive procedures. It consists of a mobile workstation with a control console, X-ray source, quality assurance tools, and various applicators (spherical, needle, and flat) that enable targeted radiation delivery in operating rooms or clinical settings for cancer treatment.

The INTRABEAM 700 uses the same XRS 4 X-ray source, energy levels (40–50 keV), maximum output (0.6 Gy/min), and radiation geometry as the predicate INTRABEAM 600. Key differences include upgraded software (Version 5.0 vs. 4.0), a new Control Console 700 with different power supply design, addition of wireless/RFID connectivity and auto-balancing features in the SMART Stand, updated UNIDOS Romeo Electrometer, and new single-use sterile SMART Spherical Applicator with EO sterilization instead of user-sterilized reusable applicators.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic immunity), IEC 60601-2-8 (therapeutic X-ray equipment), IEC 60601-1-6 (usability), IEC TR 60601-4-2 (electromagnetic immunity guidance). Testing also included biocompatibility assessment, sterility and shelf-life evaluation, performance bench testing, software verification and validation, and human factors validation per FDA guidance.

The subject device maintains identical indications for use, same X-ray source, radiation output, energy levels, and treatment methods as the predicate. Although new accessories and upgraded features are introduced (SMART Stand, new software version, wireless connectivity, RFID modules), these represent incremental enhancements that do not alter the fundamental therapeutic function or risk profile. Biocompatibility, sterilization, electrical safety, radiation safety, and software all demonstrate compliance with applicable standards, and the new materials and single-use format of the SMART Spherical Applicator do not adversely affect clinical performance. Therefore, the technological characteristics and testing results establish substantial equivalence despite the modernized design and added convenience features.