(48 days)
WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology, small-parts.
The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
This equipment is high resolution linear/convex ultrasound scanning diagnostic equipment. It adopts micro-computer control and digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), real time dynamic receiving apodization, real time dynamic receiving focusing (DRF), Digital frequency scan (DFS), frame correlation technologies to endue its image with clarity, stability and high resolution.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KLOOO79 device (WED-3100 Digital Ultrasound Scanner).
It's important to note that this document is a 510(k) summary, which often provides a high-level overview. Detailed study protocols and results are typically found in the full 510(k) submission, which is not provided here. Therefore, some information requested might be absent or generalized.
Acceptance Criteria and Device Performance
The acceptance criteria for the device are generally implied by the technical specifications and the statement that "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." For specific performance criteria, we look at the 'Accuracy' and 'Resolution' values provided in the technical specifications.
Table of Acceptance Criteria and Reported Device Performance (Implied from Technical Specifications)
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Measurements) | Error ≤ ±10% | Error ≤ ±10% (Stated as met) |
| Resolution (C1-11 Probe) | Lateral ≤1 mm (Depth≤60mm), Axial ≤1 mm (Depth≤80mm) | Lateral ≤1 mm (Depth≤60mm), Axial ≤1 mm (Depth≤80mm) (Stated as met) |
| Resolution (L1-5 Probe) | Lateral ≤3 mm (depth≤80mm), ≤5 mm (80mm |
§ 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.