EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

The EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is an endoscopic ultrasound imaging system that generates ultrasound waves via transducers to acquire and display real-time ultrasound images of target tissues and organs. It is intended for use with Olympus ultrasound endoscopes and probes to visualize the gastrointestinal tract, biliary and pancreatic ducts, airways, and other anatomical regions, and can provide measurements of distance, area, velocity, and tissue strain.

Both the subject and predicate devices share identical design, materials, principle of operation, and energy source with acoustic output below 720 mW/cm². Both provide B mode, Pulsed Wave Doppler, Color Doppler, Power Doppler, and Tissue Harmonic Echo modes. The subject device adds Strain Ratio/Strain Histogram and Shear Wave Quantification capabilities (supported by a reference device), and Contrast Harmonic Echo mode, whereas the predicate included 3-D imaging which the subject does not.

IEC 60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-2-37, IEC 60601-4-2 (electrical safety and EMC); ANSI AAMI ISO 14971 (risk management); ANSI AAMI IEC 62304 (software lifecycle); ANSI AAMI IEC 62366-1 (human factors); ISO 17664-1 (cleaning/disinfection validation). Compliance also verified against FDA Guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (February 21, 2023).

The subject device and predicate share the same technological characteristics—design, materials, operating principles, and energy source—with identical acoustic output limits and core imaging modes (B, PWD, Color Doppler, Power Doppler, Harmonic Imaging). Although the subject adds Shear Wave Quantification and Contrast Harmonic Echo (supported by nonclinical testing comparing to a reference device) and omits 3-D imaging, these differences do not introduce new safety or effectiveness issues. The indications for use are similar; additional clinical applications listed for the subject (intraluminal ultrasound for airways, trans-rectal, trans-urethral applications) were already identified as clinical applications for the predicate. Comprehensive nonclinical testing demonstrated the subject device performs as safely and effectively as the predicate.