(80 days)
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for postdeployed stent expansion in self-expanding peripheral vascular stents.
The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.
The provided text is a 510(k) summary for the PolarCath™ Peripheral Dilatation System. It states that "In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria." However, it does not provide specific details about the acceptance criteria or the study that proves the device meets them.
Therefore, I cannot provide the requested information in the structured format. The document only contains the following general statement about performance data:
The requested information (acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training set) is not available in the provided text.
§ 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).