(415 days)
The Beverly Referential Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the peritoneum or the right atrium of the heart.
The Beverly Referential Valve is intended to minimize the effect of hydrostatically induced flow when the patient is sitting, standing or semi-recumbent when compared to devices not containing an anti-siphon device.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only (Per 21 CFR 801.109)
Beverly Referential Valve
The provided text is a 510(k) clearance letter from the FDA for the "Beverly Referential Valve with Integral Peritoneal Catheter." It states that the device is substantially equivalent to a predicate device but does not contain any information regarding acceptance criteria, device performance results, or details of a study.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies. The document only confirms the device's clearance for marketing.
§ 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).