Mendaera Guidance System

The Mendaera Guidance System is a software-controlled, electromechanical system that provides real-time guidance for precise placement of interventional devices during ultrasound-guided percutaneous procedures. It consists of a handheld robot that attaches to an ultrasound probe, a cart with touchscreen and software, sterile drape kits, and instrument guide kits compatible with needles ranging from 14G to 25G. The system is intended for use with pediatric and adult patients in physician offices, clinics, and hospitals.

The proposed device differs from the predicate (Verza Guidance System, K160806) in several ways: it offers both in-plane and out-of-plane guidance capabilities, whereas the predicate only offers in-plane guidance. The proposed device automatically displays the instrument trajectory for the chosen guide angle, while the predicate requires manual positioning. It mounts via a latching feature compared to the predicate's bracket system. The gauge insert sizes range from 14G to 25G in the proposed device versus 12F to 25G in the predicate. Both systems use similar plastic and metal materials and share the same basic function of providing guidance overlaid on live ultrasound images.

ISO 11135, ANSI AAMI ISO 11607-1, ANSI/AAMI ST98, ASTM F1980-21, ASTM F2096-11, ASTM D4322-22, ASTM D4169-22, ASTM F88/F88M-23, IEC60601-1, IEC60601-1-2, IEC60601-1-6, IEC TS 60601-4-2, IEC62366-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, and IEC 62304 for software lifecycle processes. FDA guidance documents on biological evaluation and software content in medical devices were also referenced.

The Mendaera system is substantially equivalent because, despite technological differences in design and operation, it maintains the same fundamental intended use as the predicate: positioning interventional devices relative to an ultrasound transducer during diagnostic or therapeutic procedures. The differences—such as automatic versus manual trajectory display, latching versus bracket mounting, and expanded out-of-plane capability—do not raise new safety or effectiveness concerns, as demonstrated by comprehensive nonclinical testing (biocompatibility, sterilization, electrical safety, EMC, software validation), animal studies showing safe and effective use, and human factors validation confirming usability. The PCCP for future interoperability with additional ultrasound systems does not introduce new safety questions because it involves only software modifications using the same test methods and acceptance criteria as the cleared device.