(115 days)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/Color/PWD, B/Power/PWD. The Voluson E10 is intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
I am sorry, but the provided text is a 510(k) premarket notification submission from GE Healthcare for their Voluson E10 ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
The document explicitly states: "The subject of this premarket submission, Voluson E10 did not require clinical studies to support substantial equivalence." (Page 7)
Therefore, it does not contain information regarding:
- Acceptance criteria for device performance in a clinical study.
- A study proving the device meets specific acceptance criteria based on clinical performance.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance metrics related to clinical effectiveness.
The "Summary of Non-Clinical Tests" (Page 6) mentions evaluations for acoustic output, biocompatibility, cleaning, disinfection, and thermal/electrical/electromagnetic/mechanical safety, conforming to applicable medical device safety standards. However, these are non-clinical technical safety and performance evaluations, not clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.
§ 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.