(51 days)
The device is a general purpose ultrasound system. 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; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal, Intraoperative, Intraoperative Neurological.
Mode of Operation: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, Other [Notes].
The Voluson E6/E8/E8Expert/E10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
The provided 510(k) Premarket Notification Submission for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System states that clinical studies were not required to support substantial equivalence (page 2).
Therefore, there is no information in this document regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, training set size, or how ground truth for the training set was established.
The substantial equivalence determination was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety) and compliance with applicable medical device safety standards (page 1). The device was found to conform with the following voluntary standards:
- IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- ISO14971, Application of risk management to medical devices
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)
Additionally, the development process included quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), and Safety testing (Verification). Transducer materials and other patient contact materials were also evaluated for biocompatibility.
The acceptance criteria for the device are therefore implicit to its compliance with these non-clinical standards and internal quality assurance measures, as no separate clinical performance metrics are provided.
§ 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.