(399 days)
Allows for drainage and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only.
This looks like a 510(k) summary for a medical device. Based on the provided text, there is no study described that demonstrates the device meets acceptance criteria. The document mainly focuses on establishing substantial equivalence to a predicate device for regulatory approval.
Specifically, the document states:
- Description: "The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only."
- Intended Use: "The XDS allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP."
- Predicate Device: Medtronic Becker External Drainage and Monitoring System, K984053
A 510(k) summary typically includes a declaration that the device is substantially equivalent to a legally marketed predicate device. This often means that the device has similar technological characteristics and/or that differences in technological characteristics do not raise different questions of safety and effectiveness. It does not necessarily require the submission of extensive clinical performance studies comparing the new device against specific acceptance criteria in the same way a new drug or novel device might.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document is solely a regulatory filing for substantial equivalence based on a predicate device.
§ 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).