(87 days)
The major indication of external drainage is the management of hydrocephalic shunt infections. External drainage of cerebrospinal fluid (CSF) to control increased intercranial pressure may also be indicated if an internal shunt is not indicated or during the treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician.
Lumbar Drainage Accessory Kit
The provided text is a 510(k) clearance letter from the FDA for a device called "Lumbar Drainage Accessory Kit". It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (training or test sets), expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.
The document primarily focuses on the FDA's determination of substantial equivalence for the device to previously marketed devices and outlines regulatory responsibilities. Section 8 ("DEVICE INDICATIONS FOR USE") describes the intended uses of the device but does not include any performance data or study details.
§ 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).