(27 days)
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.
The provided text, a 510(k) summary for the CPS Locator 3D Delivery Catheter, does not contain the information requested about acceptance criteria or a study proving that an AI/device meets specific performance criteria.
This document describes a medical device (a delivery catheter) and its substantial equivalence to a predicate device, focusing on physical and functional characteristics, indications for use, and manufacturing/sterilization compliance, not on an AI-driven diagnostic or performance study.
Therefore, I cannot provide the requested information, which typically pertains to the validation of AI-based medical devices or diagnostic tools. The document's purpose is to demonstrate that the catheter itself is substantially equivalent to an already cleared device, not to present data on a new, AI-driven performance metric.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).