BladderScan Prime PLUS System

The BladderScan® PRIME PLUS system is a non-invasive diagnostic ultrasound device designed to accurately measure urinary bladder volume using B-mode imaging enhanced by patented neural network technology. It aims to provide clinicians with reliable bladder volume data for male, female, and pediatric patients through a portable system with a simplified user interface and no routine calibration requirement.

The BladderScan® PRIME PLUS system is a diagnostic ultrasound device designed for the non-invasive measurement of urinary bladder volume. It utilizes B-mode ultrasonic pulsed echo imaging and patented neural network technology to calculate bladder volume based on a complex, multifaceted image of the bladder. The system features a mechanical sector probe with a 13mm diameter, operating at nominal acoustic output frequencies of 2.49 / 1.72 MHz, a resonant frequency of 2.95 MHz, a 120-degree sector angle, and 12 scan planes. Key information such as bladder volume, directional aiming with real-time feedback, and system status is displayed on an LCD screen. The portable device operates on a lithium-ion battery and includes a charging cradle, along with accessories like a printer and mobile cart. The system is intended for use by physicians or medical professionals on male, female, and pediatric patients for abdominal B-mode imaging of the bladder, with a measurement range of 0 to 999 mL. It reports a measurement accuracy of ±7.5 mL for volumes between 0-100mL, and an accuracy of "± 7.5% ± 15% ± 15mL" for volumes between 100-999mL. Technological advancements include a simplified single mode of operation accommodating male, female, and small child patient types, and no longer recommends annual calibration. Non-clinical testing confirmed its safety and performance, meeting standards for biocompatibility, electrical safety (AAMI/ANSI ES 60601-1, IEC 60601-2-37), electromagnetic compatibility (IEC 60601-1-2), and acoustic output (Maximum Mechanical Index 0.424, Maximum Thermal Index ≤ 1.0, ISPTA ≤ 1.0 mW/cm2, ISPPA ≤ 12.0 W/cm2). The device is contraindicated for fetal use, pregnant patients, patients with ascites, or those with open skin or wounds in the suprapubic region.

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. How does the "patented neural network technology" improve bladder volume calculation accuracy or robustness compared to conventional B-mode algorithms, especially in challenging patient anatomies (e.g., post-surgery, obesity)?; What is the specific breakdown or meaning of the measurement accuracy stated as "± 7.5% ± 15% ± 15mL" for the 100-999 mL range, and under what conditions does each component of this error margin apply?; Given the simplified single mode of operation for male/female/small child, how does the system account for anatomical differences (e.g., presence or absence of uterus in females, smaller bladder size in children) that previously required distinct mode selections?; What are the practical implications and supporting data for removing the annual calibration recommendation compared to the predicate device which required it?; Were any specific usability studies conducted to validate the effectiveness of the BladderScan® PRIME PLUS's simplified user interface in reducing user error and improving workflow efficiency in diverse clinical settings, beyond general compliance with usability standards?