(101 days)
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiaς (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/ Prostate) (TR): Transvaginal (TV).
Mode of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/ Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.
The subject device is a Track 3 device, primarily intended for general-purpose radiology evaluation and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson SWIFT+ provide digital acquisition, processing and display capability. Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with control panel, full touch monitor, optional image storage and printing devices. It provides high-performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The provided text is a 510(k) summary for the GE Voluson SWIFT, Voluson SWIFT+ diagnostic ultrasound system. It outlines the device's technical characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.
However, the document explicitly states that clinical studies were NOT required or performed to support the substantial equivalence of the Voluson SWIFT, Voluson SWIFT+.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and performance studies, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
The submission focuses entirely on non-clinical tests to demonstrate safety and effectiveness, based on compliance with electrical, mechanical, and safety standards, and by showing substantial equivalence to previously cleared predicate devices through similar technology, intended use, imaging modes, and acoustic power levels.
The relevant section in the document states:
"Summary of Clinical Tests: The subject of this premarket submission. Voluson SWIFT, Voluson SWIFT+, did not require clinical studies to support substantial equivalence."
§ 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.