(228 days)
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-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.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, 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.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer as following pages.
B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz.
The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.
The provided text is a 510(k) summary for the "B-Ultrasound Diagnostic System" (K232895). It primarily focuses on demonstrating substantial equivalence to a predicate device (K170856) based on non-clinical testing. Crucially, it explicitly states there was "No clinical study included in this submission," and therefore, it does not contain the detailed information about acceptance criteria and clinical study results that you requested.
Therefore, I cannot extract the information required to populate the table or answer questions 2-9 from the provided text. The document indicates that the device's substantial equivalence and performance were evaluated through non-clinical tests and compliance with various international standards related to electrical safety, EMC, performance, and biocompatibility.
Here's an explanation of why I cannot fulfill your request based on the provided document:
- No Clinical Study Data: The document explicitly states "No clinical study is included in this submission." This means there is no data from human studies or specific performance metrics from such studies.
- Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute performance against specific clinical acceptance criteria in a human study.
- Non-Clinical Testing: The "Non-Clinical Test Conclusion" section lists various standards (IEC, ISO) that the device complies with, but these are general safety and performance standards for medical electrical equipment and ultrasound devices, not acceptance criteria for a specific clinical task or diagnostic accuracy.
- Lack of Performance Metrics for Specific Clinical Use: While the indications for use are listed (e.g., abdomen, gynecology, pediatric), the document doesn't provide performance metrics (like sensitivity, specificity, accuracy, dice score etc.) related to these applications, which would typically be found in a clinical study report.
In summary, the provided document does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria in a clinical context.
§ 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.