(114 days)
The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool when used in conjunction with an intravascular ultrasound catheter. The System is a medical device for use by or on the order of a physician. The HD-IVUS Ultrasound Imaging System is comprised of a System Console with a touch screen monitor, a Roll Stand, or bed-rail swing arm mount, a Patient Interface Module (PIM), a Power Supply, and an Intravascular Ultrasound Catheter (510(k) cleared and sold separately). The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received by the transducer and sent to the System Console where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.
The provided text does not contain information about acceptance criteria or specific study results for the HD-IVUS Ultrasound Imaging System or its Linear Translation System accessory. The document is a 510(k) summary for a submission that claims substantial equivalence to predicate devices, focusing on technical characteristics and compliance with general safety standards.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document indicates:
- The device is an HD-IVUS Ultrasound Imaging System with a Linear Translation System (LTS) accessory. The LTS is the subject of this 510(k) submission.
- The submission is a "Special 510(k) (accessory to device)", indicating it's for an accessory to an already cleared device, and thus likely focuses on demonstrating that the accessory does not raise new questions of safety or effectiveness compared to the existing system or predicate accessories.
- Non-clinical tests were conducted for determination of substantial equivalence. These included Electromagnetic Compatibility (compliant with IEC 60601-1-2) and Electrical Safety and Acoustic Safety (compliant with IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37). The results summarized are simply "Compliant" with these standards.
- Performance Data: The document explicitly states "Summary of Non-clinical tests Conducted for Determination of Substantial Equivalence" and under "Performance Test Summary - New Device" it lists standards and results, but these relate to safety and compatibility rather than clinical performance metrics of the imaging system itself.
In summary, the provided text lacks the detailed performance criteria and study results typically found for a standalone clinical performance evaluation. The focus of this 510(k) is on the substantial equivalence of an accessory (Linear Translation System) to predicate devices and compliance with relevant safety and electromagnetic standards.
§ 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).