(50 days)
PBSV4.1 bladder scanner is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Palm bladder scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.
This document is a 510(k) summary for the Meike PBSV4.1 Palm Bladder Scanner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in a clinical context.
However, based on the provided text, we can extract information regarding acceptance criteria and the claimed device performance, as well as the types of tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (from Predicate Device) | Reported Device Performance (PBSV4.1) |
|---|---|---|
| Range of Measurement | Adult: 0-999ml | |
| Small Child: 0-200ml | 0-999ml | |
| Accuracy | ±15%, ±15ml | • ± 25% (60ml ≤ volume ≤ 150ml) |
| • ± 15% (150ml ≤ volume ≤ 999ml) | ||
| Time from 3D Scan Initiation to Result Display |
§ 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.