ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

The Ultrasonic Probes UM-S20-17S and UM-S20-20R are diagnostic ultrasound transducers designed for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. They are inserted through a bronchoscope channel and connected to an Olympus Endoscopic Ultrasound Center to produce real-time B-mode ultrasound images. Both probes operate at 20 MHz frequency and produce 360-degree mechanical radial sonograms for diagnostic purposes in healthcare facilities.

Both subject probes use 20 MHz frequency and mechanical radial scanning with a 360° field of view, matching the predicate (which used 10 MHz and 17 MHz) and reference device. Key differences include smaller transducer sizes (0.75 × 2.3 mm and 1.0 × 2.3 mm versus predicate's unspecified size), slightly different insertion tube diameters, and compatibility with Olympus ultrasound systems (EU-ME2, EU-ME2 Premier Plus, EU-ME3) rather than Fujifilm's system. Both employ direct contact method only and use liquid paraffin as the ultrasonic medium.

Performance testing included acoustic output compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA diagnostic ultrasound guidance. Biocompatibility testing per ISO 10993 series (parts 1, 5, 10, 12, 17, 18, 23). Reprocessing validation per ISO 17664-1, AAMI TIR12, ANSI AAMI ST98, ST58, ISO 11135, and ISO 11138-2. Electrical safety and EMC per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, and IEC TR 60601-4-2.

The subject devices are substantially equivalent to the Fujifilm predicate because both are diagnostic ultrasound probes with identical intended use (intraluminal imaging of upper airways and tracheobronchial tree), identical B-mode operation, and equivalent fundamental performance characteristics including 360° mechanical radial scanning, frame rate (6.67 rps), and contact method. Although the subject devices use 20 MHz versus the predicate's dual 10 MHz and 17 MHz frequencies, and have different transducer sizes and insertion tube dimensions, these are minor design variations that do not raise new safety or effectiveness questions. Non-clinical testing demonstrated equivalent acoustic output, biocompatibility, reprocessing durability, and electrical safety, supporting functional equivalence to the predicate device.