(51 days)
The Small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
The small Peripheral Cutting Balloon Catheter (PCB) with Monorail (MR) delivery system has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The sPCB features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.
This document is a 510(k) summary for the Boston Scientific Corporation Small Peripheral Cutting Balloon with Monorail Delivery System. It is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document outlines:
- The device's intended use.
- The device's description.
- Its classification and product code.
- Its predicate device (K052038).
- The conclusion that the new device is substantially equivalent to the predicate device due to shared indications for use, design, composition, and function.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them from the provided text. This document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a performance study report.
§ 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).