EPIQ Series Diagnostic Ultrasound System

The EPIQ Series Diagnostic Ultrasound System, enhanced by the new X11-4t transducer, provides advanced 3D transesophageal cardiac imaging capabilities, particularly for pediatric patients, utilizing phased array technology for detailed diagnostic ultrasound and fluid flow analysis. The system's methodology is grounded in ultrasonic pulsed Doppler and echo imaging, with its safety and effectiveness for diverse clinical applications, including image-guided cardiovascular interventions, confirmed through comprehensive non-clinical testing and adherence to established medical device standards.

The EPIQ Series Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis across a wide range of human body applications. This submission specifically introduces the X11-4t transducer, a 2500 element phased array 3D transesophageal (TEE) cardiac transducer designed for patients weighing 5 kg and greater. The X11-4t operates at a frequency of 4-11 MHz and supports Cardiac Adult, Cardiac Pediatric, and Transesophageal (Cardiac) indications. It is compatible with EPIQ platform systems running software version 11.0 or higher, including the EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, and EPIQ 5. The system utilizes ultrasonic pulsed Doppler and echo imaging principles and can be used in various clinical environments such as clinics, hospitals, and at the point-of-care. When integrated with Philips EchoNavigator, the EPIQ system can assist interventionalists and surgeons with image guidance during cardiovascular disease treatments that employ both live X-ray and live echo guidance. The device's safety and effectiveness were established through non-clinical performance testing, including compliance with standards like ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359 for thermal and mechanical indices, and ISO 10993-1 for biocompatibility. Design control activities, including requirements review, risk analysis, product specifications, and design reviews, also supported the system's safety and effectiveness, with all pre-determined acceptance criteria being met.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific advantages of the X11-4t transducer's 2500 element phased array design and 4-11 MHz frequency range compared to previous TEE transducers in the EPIQ series, particularly for pediatric cardiac imaging in patients as small as 5 kg?; How does the integration with Philips EchoNavigator enhance image guidance for interventionalists and surgeons during cardiovascular procedures using both live X-ray and live echo, and are there quantitative measures of improved procedural outcomes associated with this integration?; Beyond the listed safety standards, what specific non-clinical performance data (e.g., image resolution, penetration depth, Doppler sensitivity) demonstrated the X11-4t's effectiveness for its intended cardiac indications, especially in challenging pediatric cases?; The document mentions a broad range of indications for the EPIQ system; how does the X11-4t transducer specifically contribute to or enhance the capabilities for Cardiac Adult, Cardiac Pediatric, and Transesophageal (Cardiac) applications versus other transducers compatible with the EPIQ series?; What are the thermal and mechanical index characteristics of the X11-4t transducer, and how do they compare to existing TEE transducers, particularly concerning safety in pediatric patients weighing 5 kg and greater?