(64 days)
The VisionWire coronary guide wire is intended for the following applications:
- Its positioning in the coronary vascular system (probing coronary vessel anatomy)
- Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:
- Measuring the left ventricular threshold
- Measuring the intracardiac signals
- Temporary pacing of the left ventricle
- As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus
The VisionWire coronary guidewire is a transvenous wire with sensing and stimulation capabilities. The VisionWire is intended to be used to facilitate the positioning of left ventricular (LV) pacing leads, with compatible guidewire lumen, within the coronary venous system during the implantable pulse generator (IPG) or Implantable Cardioverter Defibillator (ICD) for Cardiac Resynchronization Therapy (CRT). The VisionWire is used as a guide to position the over-the-wire (OTW) lead, especially in angled or tortuous veins. Prior to lead positioning, the VisionWire can be used to perform comparative intraoperative measurements of various pacing sites within the coronary venous system. Thus the physician can identify an appropriate pacing site for a LV lead.
The VisionWire coronary quidewire is a disposable medical device designed for single use only.
The provided text is a 510(k) premarket notification for the BIOTRONIK VisionWire Coronary Guidewire. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table or answer the specific questions about the study design and results using only the provided text. The document focuses on regulatory submission details rather than detailed performance study outcomes.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report that details the device's performance in meeting specified acceptance criteria.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.