(25 days)
The PolarCath Peripheral Dilatation System's intended use is for the dilatation of 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.
The provided text describes the PolarCath™ Peripheral Dilatation System, its indications for use, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document is a 510(k) clearance letter from the FDA, which focuses on regulatory approval based on demonstrating "substantial equivalence" to existing legally marketed devices. It explicitly states:
"The substantial equivalence of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific."
This means that while performance data and acceptance criteria presumably exist and were submitted to the FDA as part of their "design control activities and bench testing," they are not detailed or presented in this public document. The FDA's letter (K092455) confirms the device's clearance but does not publish the specific performance study results or acceptance criteria used for that clearance.
§ 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).