(57 days)
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
- 활 ISO 10993-1 Biocompatibility
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or machine learning.
The document is a 510(k) summary for the AcuNav Diagnostic Ultrasound Catheter, stating its substantial equivalence to a previously marketed device. It primarily focuses on regulatory approval based on equivalence and safety testing (biocompatibility), not on performance metrics against specific acceptance criteria for diagnostic accuracy.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, device performance, study methodology, or AI-related information. This information is simply not present in the provided text.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).