(48 days)
The Impulse™ and Expo™ Anqiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The Impulse™ and Expo™ Angiographic Catheters are intended for use in general intravascular applications to provide a pathway through which contrast media may be introduced.
The Impulse™ and Expo™ Angiographic Catheters are single Jumen catheters offered in three distal curve shapes: Selective, Pigtail and Multi-Purpose. The Expo Catheter is offered in 5F, 6F, and 7F outer diameter, and the Impulse Catheter is offered in 5F and 6F outer diameter. The device shafts have multiple polymer layers with a stainless steel braid embedded between the layers, and an atraumatic tip that does not contain a braid. The proximal end consists of an insert molded polymer hub on all models, and a strain relief on all models except the 7F Expo.
The provided text describes a 510(k) premarket notification for Impulse™ and Expo™ Angiographic Guide Catheters. As such, the information contained within is related to medical device clearance based on substantial equivalence to a predicate device, rather than a study proving a device meets acceptance criteria using a machine learning algorithm.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets those criteria for an AI/ML context, because the document is about a different type of medical device (catheters) and a different regulatory pathway (510(k) for substantial equivalence to a predicate, not performance testing of an AI algorithm).
Specifically, the document states: "Summary of Clinical Testing: Clinical Evaluation was not required for these devices." This explicitly means there was no clinical study, let alone one involving AI or setting performance acceptance criteria in the way you've outlined.
The document details non-clinical bench testing (e.g., Burst Pressure, Hub Leakage, Tensile Test, Biocompatibility) to demonstrate the device's substantial equivalence to previously cleared devices. This is a common pathway for physical medical devices that are similar to existing ones.
§ 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).