(122 days)
The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.
The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.
The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the balloon/stent catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.
Here's a breakdown of the acceptance criteria and study information for the Corindus CorPath® 200 System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list "acceptance criteria" with specific thresholds in a tabular format. Instead, it presents the results of a clinical study that demonstrates the device's acceptable performance. The key performance metrics and their reported outcomes are summarized below:
| Performance Metric | Reported Device Performance (CorPath 200 System) |
|---|---|
| Clinical Procedural Success Rate | 97.6% |
| Post-procedure Stenosis |
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).