ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

The ULTRASONIC PROBE UM-3R and UM-G20-29R are diagnostic ultrasound transducers designed for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary ducts, pancreatic ducts, and surrounding organs. They operate in B-mode, use a 20 MHz piezoelectric transducer, and produce 360-degree mechanical/radial sonograms. The UM-3R supports both direct contact and sterile de-aerated water immersion methods; the UM-G20-29R supports direct contact only and includes a guide wire port for use in biliary and pancreatic applications.

Both subject devices use a 20 MHz frequency transducer with B-mode display, rectangular transducers sized 1.55 × 2.3 mm (UM-3R) and 1.2 × 2.3 mm (UM-G20-29R), 360° scanning field of view, 6.67 rps frame rate, and axial/lateral resolution of 2 mm or less. The UM-G20-29R differs by including a guide wire port and shorter insertion tube outer diameter (~2.2–2.9 mm vs. ~2.5 mm). Both differ from the predicate (10–17 MHz frequency, 1 mm or less axial resolution) but match the reference device UM-3R on key parameters.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37; IEC 62359, IEC 62127-1; ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-17, ISO 10993-18, ISO 10993-23; ISO 17644-1, AAMI TIR12, ANSI AAMI ST98, ANSI AAMI ST58, ISO 11135, ISO 11138-2; FDA Guidance on diagnostic ultrasound marketing clearance, human factors, and reprocessing validation.

Although the subject devices differ from the predicate in frequency (20 MHz vs. 10–17 MHz), axial/lateral resolution (2 mm vs. 1 mm), and compatible ultrasound systems, these differences do not raise new safety or effectiveness questions because performance was verified through acoustic output, durability, accuracy, electrical safety, EMC, and reprocessing validation testing. The devices match the predicate in intended use (intraluminal GI/biliary/pancreatic imaging), B-mode operation, mechanical scanning method, and general design. Biocompatibility and electrical/EMC compliance testing confirmed equivalence. The UM-G20-29R's guide wire port is a minor design enhancement for a specific clinical application (small duct imaging) that does not change fundamental safety or efficacy.