(60 days)
This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature. The catheter should not be used in the cerebral vessels.
The SwiftNINJA® Steerable Microcatheter is a microcatheter with a steerable/articulating distal tip. Articulation is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions. The steering dial and steerable tip are connected via two operating wires. The wires are located on both lateral walls of the catheter shaft with a connection point on the distal catheter. Tension is applied to either one of the wires by turning the steering dial for manipulation of the tip direction. Once the direction of steerable tip is determined, the steering dial lock may be used for maintaining the intended direction. The outer surface of the distal segment of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the microcatheter into the vasculature.
The provided text describes the 510(k) clearance for the SwiftNINJA® Steerable Microcatheter (K211525). It details the device's intended use and its substantial equivalence to a predicate device (K161921). However, the document is a regulatory clearance letter and does not contain information about the development or testing of an Artificial Intelligence (AI) / Machine Learning (ML) enabled device.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving an AI/ML device meets them, as the clearance is for a physical medical device, not an AI/ML product. The questions concerning sample size, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set details are all relevant to the validation of AI/ML models, but they are not addressed in this filing for a hardware device.
The "Performance Testing-Bench" and "Biocompatibility testing" sections describe the acceptance criteria and testing performed for the physical microcatheter, relating to its mechanical and biological safety and functionality. If the question were about the validation of this specific physical device, one could extract information from these sections.
However, since the prompt specifically asks for details related to AI/ML device validation (e.g., "human readers improve with AI vs without AI assistance," "standalone algorithmic performance," "training set," "ground truth establishment"), I must state that this document does not contain such information because it is for a physical medical device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).