(87 days)
The Peritoneal/Cardiac Catheter is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the peritoneal cavity of the right atrium of the heart. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Not Found
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) clearance letter for a Peritoneal/Cardiac Hydrocephalic Shunt Catheter, indicating that the device has been found substantially equivalent to a predicate device.
Therefore, I cannot populate the requested table and information based on the provided text. The document refers to the "indications for use" as being in an enclosure, but the enclosure itself is not provided. There is no mention of performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).