(43 days)
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatricand Peripheral vessel.
The SONOACE R7 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or sample size/ground truth establishment for training sets.
The document is a 510(k) Premarket Notification for the SONOACE R7 Diagnostic Ultrasound System. It primarily focuses on:
- Device Description and Intended Uses: Explaining what the device is and its clinical applications.
- Technological Characteristics Comparison with Predicates: Demonstrating substantial equivalence to previously cleared devices by comparing features and compliance with standards.
- Bench and Non-Clinical Tests: Stating that the device underwent evaluations for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable standards.
- Conclusion: Asserting the device's safety, effectiveness, and substantial equivalence to predicate devices.
- Indications for Use Statements for various transducers: Listing the specific body parts and modes of operation for each transducer.
The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence." This means no clinical studies, and therefore no acceptance criteria or performance data, were generated for this submission. The substantial equivalence argument relies on the inherent safety and performance of the predicate devices and the new device's adherence to relevant safety and performance standards.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.