(88 days)
The Contour Flex Plus Valve is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. It also prevents over-drainage of CSF due to siphoning.
The Contour Flex Plus Valve is designed for use as a cerebrospinal fluid shunt. It is the commercially available Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). The Radionics Contour Flex Plus Valve is a single unit which combines the features of the Contour Flex Valve and Siphon Limiting Device into a single, smaller unit for the surgeon's convenience. The Contour Flex Plus Valve has the same intended use and design characteristics as the PS Medical Delta CSF Flow Control Valve. Its valve component is the same as the Radionics Contour Flex Valve. Both the Radionics Contour Flex Plus Valve and the PS Medical Delta CSF Flow Control Valve have a siphon limiting device with an outlet port and a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.
This document is a 510(k) premarket notification for a medical device (Radionics Contour Flex Plus Valve) and does not contain the acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.
The provided text is a summary of safety and effectiveness for a Class II medical device, specifically a central nervous system fluid shunt component. It focuses on demonstrating substantial equivalence to predicate devices, describing the device's function and intended use, and outlining safety information.
Therefore, it is impossible to extract the requested information regarding acceptance criteria, device performance, AI/ML study details, sample sizes, ground truth establishment, or expert qualifications from this document.
§ 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).