X9 Ultrasound System

The X9 Ultrasound System is an ultrasound imaging device intended to guide healthcare professionals in accessing arteriovenous fistulas and grafts (AVF/G) for hemodialysis. It consists of a handheld ultrasound handpiece with a transducer connected via cable to a user-supplied computer, plus software that displays a graphical interface showing when the handpiece is properly aligned with the vascular access to assist with the preliminary cannulation assessment.

Both the subject device and predicate (BD Prevue II) are B-mode ultrasound imaging systems using pulsed echo technology with software analysis during use, intended for hospital/clinic settings operated by trained clinicians. The X9 System incorporates a machine learning model to identify vessel presence and alignment, whereas the predicate uses standard ultrasound guidance without specified algorithmic analysis.

Not stated in this summary. The document lists test categories performed (acoustic safety, electrical safety, electromagnetic compatibility, mechanical and thermal safety, software verification, cybersecurity, bench performance, user needs, and ship testing) but does not cite specific consensus standards such as ISO, IEC, or ASTM.

The X9 System is substantially equivalent to the BD Prevue II because the indications for use (ultrasound imaging of vascular access for hemodialysis guidance) are encompassed within the predicate's broader indications, both devices employ B-mode ultrasound probes with software analysis in the same clinical setting, and non-clinical testing—particularly machine learning model validation on 63 participants showing 94.5% access presence sensitivity and 0.492 mm average lateral error—demonstrates safe and effective performance equivalent to the predicate.