(150 days)
The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.
The Imager II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are also added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.
This is a medical device (catheter) and not an AI/ML device. The provided text is a 510(k) summary for a medical device called "Imager II Angiographic Catheters." This document describes the device, its intended use, and its equivalence to previously cleared devices. It does not contain information related to software, algorithms, or any AI/ML components. Therefore, the specific questions regarding acceptance criteria, study details, data provenance, ground truth, expert adjudication, or MRMC studies for AI/ML performance cannot be answered from this document.
The document states:
- Technological Characteristics: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."
- Non-Clinical Test Summary: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."
This indicates that the device's clearance is based on its substantial equivalence to a predicate device, meaning it has the same technological characteristics and similar non-clinical test performance. There is no study described within this document that "proves the device meets the acceptance criteria" in the context of an AI/ML device's performance. The "acceptance criteria" for this type of medical device would typically relate to physical performance characteristics (e.g., tensile strength, flow rates, biocompatibility, radiopacity, etc.) established through non-clinical bench testing, which are only summarized as being "same as" the predicate.
§ 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).