(152 days)
NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows.
NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
NovaGuide 2 is a mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) ultrasound system. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide 2 is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
NovaGuide 2 is a cart-mounted system for use in hospitals or clinics. The system is comprised of a computer, Doppler Robotics Unit (DRU), probe pods, patient headmount unit (PHU) and two reusable, non-sterile 2-MHz transducers that can be operated in either robotic or manual modes. When used in robotic mode, the operator is guided in positioning the two transducers, one on each side of the patient's head. The transducers are positioned using robotic actuators that adjust the translational and angular positions using TCD signal search algorithms, which assists the operator in monitoring the blood flow velocity of the vessels via the patient's temporal acoustic windows. Visualization and detection of emboli occur through High-Intensity Transient Signals (HITS) in the display of the TCD blood flow.
The NovaGuide 2 Intelligent Ultrasound device underwent nonclinical testing to establish its performance and safety. As such, no clinical study was performed. The nonclinical testing included assessment of basic safety, essential performance, acoustic output, acoustic temperature, and functional testing of specific features.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance | Compliance with IEC 60601-2-37 for ultrasonic diagnostic equipment. | Passed. |
| Acoustic Output | Maximum derated ISPTA |
§ 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.