(474 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) for pulmonary applications.
- A patient with isolated stenosis. .
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.
The Tyshak™, and Z-MED™ PTV Catheters are coaxial over-the-wire catheters with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation.
The balloon of the Tyshak™, and Z-MED ™ models are all made of a noncompliant polyethylene, however the Z-MED™ balloon is manufactured with an increased wall thickness. The increased wall thickness allows the balloon to achieve a higher pressure before rupture occurs. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures.
The catheter body ends proximally in a molded 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size.
The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon.
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted for the NuMED, Inc. Tyshak™ PTV Catheter and Z-MED™ PTV Catheter.
The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device for market approval. It describes the device, its intended use, and states that its technological characteristics are the same as an approved PTA catheter. However, it does not include details on formal performance studies, acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in your prompt.
§ 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).