(43 days)
The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.
The BladderScan" PRIME PLUS system provides non-invasive measurement of urinary bladder volume. The system calculates the bladder volume using patented neural network technology. Volume measurements made with this technology are based on a more complex, multifaceted image of the bladder.
Bladder volume, directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system operates using a battery which includes a charging cradle.
The provided text describes the Verathon BladderScan® PRIME PLUS system, an ultrasound device for non-invasive measurement of bladder urine volume. However, the document explicitly states that "The BladderScan® PRIME PLUS System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that a study proving the device meets acceptance criteria was not conducted or provided in this submission for the purpose of demonstrating substantial equivalence. Instead, the submission relies on the device's technological characteristics being substantially equivalent to a predicate device (BladderScan® PRIME System K153101).
Therefore, I cannot provide details about acceptance criteria and a study that proves the device meets them because such a study was not required for this 510(k) submission and is not described in the provided text.
The closest information available regarding performance is the "Measurement Accuracy" listed under the "Technological Characteristics and Performance" comparison table on page 6, which states:
- Verathon BladderScan® PRIME PLUS System (This submission):
- 0-100 mL = ±7.5 mL
- 100-999 mL = ±7.5%
- Predicate Verathon BladderScan® PRIME System (K153101):
- ±15% ±15mL
This indicates that the new device has improved measurement accuracy compared to its predicate. However, this table is a
comparison of specifications, not a result of a new clinical study.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.