(236 days)
The Impress Angiographic Catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
The Merit Impress Angiographic Catheters with/without hydrophilic coating are intravascular diagnostic catheters that are intended for the administration of contrast for conducting fluoroscopic studies. The catheters are available in a variety of 4F and 5F wire-braided and non-braided configurations ranging in length from 40cm to 125cm. The device may include a marker band to assist anatomical measurements. The devices are available in a variety of tip shapes to cater to variations in physician preference and patient anatomy.
The catheters consist of a shaft with a molded hub assembly. It is the shaft that may be offered with or without a wire-braided reinforcement. The distal tip of the device is tapered for efficient volume flow and dispersion of the contrast media. The distal tip is flexible so as to minimize the potential for vessel trauma.
The provided text is a 510(k) premarket notification summary for the Impress Angiographic Catheter. It outlines the device's characteristics, indications for use, comparison to predicate devices, and the testing conducted to demonstrate its safety and performance. However, this document does not contain information about an AI/algorithm-based medical device study.
The device in question, the "Impress Angiographic Catheter," is a physical medical device used for delivering radiopaque media in the vascular system. The testing described (design verification, design validation, and biocompatibility studies) are standard for physical medical devices and do not involve AI or software performance evaluation against an acceptance criterion that would be typical for an AI/ML product.
Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI device meets those criteria based on the provided text. The document focuses on the substantial equivalence of a physical catheter, primarily due to changes in its material composition.
§ 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).