(27 days)
CODMAN HAKIM™ Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
CODMAN HAKIM™ Shunt Systems are available with or without CODMAN BACTISEAL™ catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
CODMAN HAKIM™ Shunt Systems are also available with or without SIPHONGUARD™. The SIPHONGUARD™ device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
The CODMAN HAKIM™ Shunt Systems are variable composite devices, incorporating different configurations of the above-listed predicate devices per the physician's preferences. When placing an order, the physician may choose from the following features: valve type, pressure setting, housing style, reservoir style and base, anti-siphon device, catheter interface, catheter radiolucency, catheter tip style, and catheter anti-microbial treatment.
The provided document is a 510(k) summary for the CODMAN HAKIM™ Shunt Systems. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
This type of submission primarily focuses on demonstrating equivalence to already approved devices and does not typically include detailed performance study data in the public summary. Therefore, I cannot extract the requested information from the provided text.
§ 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).