(84 days)
The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or artcriovenous dialysis fistulae.
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 510(k) summary for the PolarCath™ Peripheral Dilatation System. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria.
The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that the supporting data is held internally by the company and is not detailed in the provided 510(k) summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study that is not described in this document.
The document focuses on:
- Device Description: What the PolarCath Peripheral Dilatation System is.
- Indications for Use: What the device is intended for.
- Substantial Equivalence: How it is similar to predicate devices.
- Regulatory Information: Sponsor, contact person, product codes, classification, and the FDA's letter of clearance.
In summary, based on the provided text, the specific study details and acceptance criteria you've requested are not available.
§ 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).