(86 days)
Voluson P6 / Voluson P8 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson P6 / Voluson P8 clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including UrologyProstate) (TV),
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/Pwwer/ PWD. The Voluson P6 / Voluson P8 are 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 display, 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 accurate real-time three- dimensional imaging supporting all standard acquisition modes.
This document is an FDA 510(k) summary for the GE Healthcare Voluson P6 and Voluson P8 diagnostic ultrasound systems. It declares the device to be substantially equivalent to a predicate device and states that clinical studies were not required to support substantial equivalence.
Therefore, there is no information in this document regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only without human-in-the-loop) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on non-clinical tests and compliance with safety standards to demonstrate substantial equivalence to existing devices.
§ 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.