(9 days)
The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian 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 post-deployed stent expansion of self-expanding peripheral vascular stents.
The PolarCath Peripheral Dilatation System consists of a 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 cartridge.
This 510(k) submission for the PolarCath™ Peripheral Dilatation System does not include a study describing acceptance criteria and device performance.
Instead, it states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific." This typically means that the device was tested against engineering specifications and industry standards in a lab setting, rather than through clinical trials or performance studies involving human data.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (K051916) based on design, materials, manufacturing process, and intended use, rather than presenting novel performance data from an acceptance criteria study.
§ 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).