(28 days)
Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainout pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.
Not Found
There is no information in the provided text regarding acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Z-6 Atrioseptostomy Catheter, confirming its substantial equivalence to a predicate device. It defines the indications for use but does not contain details about a performance study, acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot provide the requested information in a table or fulfill the other points as the necessary data is not present in the provided text.
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).