(600 days)
The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
The Hansen Medical Catheter Control System and Accessories and Steerable Guide Catheter and Sheath are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, whilst enabling a physician to remain seated and away from the x-ray radiation source.
The provided text is a 510(k) summary for the Hansen Medical Catheter Control System (CCS) and Accessories, and Steerable Guide Catheter (SGC) and Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.
The provided text details:
- Device Information: Trade Name, Common Name, Classification.
- Predicate Devices: The Stereotaxis Niobe Magnetic Navigation System (K021555) is identified as the predicate.
- Device Description: The system is a master/slave control system for manipulating steerable catheters within the heart atria, allowing a physician to operate away from X-ray radiation.
- Intended Use: To facilitate manipulation, positioning, and control for collecting electrophysiological data within the heart atria using specific percutaneous mapping catheters (Polaris-DxTM and LivewireTM).
- Substantial Equivalence: The document states that based on indications for use and engineering data, the device is substantially equivalent to the predicate.
- FDA Communication: The FDA's letter confirms substantial equivalence but adds a limitation regarding the device's unproven safety and effectiveness for use with cardiac ablation catheters in treating cardiac arrhythmias, including atrial fibrillation.
In summary, this regulatory submission for a medical device (a catheter control system) focuses on substantial equivalence, not on a performance study with acceptance criteria as typically found for diagnostic or AI-driven devices.
§ 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).