(35 days)
The Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of cerebrospinal fluid (CSF) to reduce and control increased intracranial pressure.
The Neurocath Ag is an external drainage catheter composed of polyurethane and impregnated with the silver ions for the purpose of radionacity. The catheter is available with 3 holes off-set at 120" or 16 holes, in lengths of 32, 23.5, and 15.5cm. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices. The Neurocath Ag is supplied with a stainless steel stylet (for introducing it into the ventricle), a stainless steel subgaleal trochar (for tunneled catheter placement), a male luer connector, a slitted wing and a compression hub (for connecting the cathetex to the tubing set). The Neurocath Ag eatherer is available individually or packaged with the tubing set.
The provided text describes a 510(k) premarket notification for a medical device called Neurocath Ag, an external drainage catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or type of ground truth used in such studies.
The document states:
- "Biocompatibility and performance testing demonstrates the safety and efficacy of these devices."
- "Biocompatibility testing of the material demonstrate that it is nonirritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971."
- "Biocompatibility testing, performance testing and risk assessment demonstrate that the Neurocath Ag is safe and effective to use, when used in accordance with the supplied instructions for use."
These statements indicate that some type of testing was performed, but they do not provide the detailed information requested in your prompt. The focus of this 510(k) summary is on demonstrating equivalence to predicate devices, particularly highlighting a change in material (from barium impregnated silicone and silver impregnated silicone to polyurethane impregnated with silver ions) and asserting that this change does not negatively impact safety or efficacy based on testing.
§ 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).