(23 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal (Conventional, Superficial); Ophthalmic; Transesophageal; Transrectal (TR); Transvaginal (TV); Transuretheral; Intraoperative (abdominal, thoracic, & vascular); Intraoperative Neurological; Intravascular; Laparoscopic; Other (Urology/Prostate).
The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis System. It consists of a console approximately 65 cm wide, 96 cm deep and 139 cm high that provided image processing and display capability. The user interface includes a keyboard, trackball, and a color video CRT display. This modification will provide users with enhanced ability to evaluate wall motion during echocardiography.
The provided document is a 510(k) premarket notification for the GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT04. It focuses on establishing substantial equivalence to existing predicate devices based on non-clinical tests and does not include a study with explicit acceptance criteria and corresponding performance metrics for clinical efficacy or diagnostic accuracy.
The document states:
- "2. Clinical Tests: None required."
- "3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA 'Other' and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid 7 BT04 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."
This indicates that clinical studies, which would typically involve acceptance criteria and performance data, were not deemed necessary for this particular submission due to the device being substantially equivalent to already cleared devices and the well-established safety and effectiveness of diagnostic ultrasound technology.
Therefore, the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance evaluation) is not present in the provided text as it pertains to clinical validation studies. The document primarily details the device's indications for use across various clinical applications and transducers, confirming their clearance status (new indications vs. previously cleared) rather than reporting on specific performance metrics from a study.
§ 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.