(92 days)
The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume.
The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume. The device is supplied sterile and is intended for one-time use. The materials comprising the device have an established history of use in medical product manufacturing.
This document (K962097) is a 510(k) summary for a Ventricular Catheter Set. It describes the device, its intended use, and its substantial equivalence to predicate devices.
However, a crucial piece of information is missing: the entire section outlining the acceptance criteria and the study proving the device meets those criteria. The provided text only includes the administrative and descriptive parts of the 510(k) summary.
Therefore, I cannot provide the requested information in the format specified because the core information about testing, acceptance criteria, and study details is not present in the provided snippet.
To answer your request, I would need a section of the 510(k) summary that details:
- Performance testing conducted (e.g., mechanical testing, biocompatibility, sterility, flow rates).
- Specific acceptance criteria for each test.
- Results from those tests.
- Protocols for how those results were obtained.
Without that, I can only state what the document does provide, which is not what you asked for regarding acceptance criteria and study details.
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I.510 (K) SUMMARY
Submitted By:
April Lavender COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 May 24, 1996
Device:
Trade Name: Ventricular Catheter Set Common/Usual Name: Catheter, External eter . Proposed Classifica ous System Fluid Shunt Components 21 CFR 882.5550 (84JXG)
Predicate Devices:
The Ventricular Catheter Set is similar in terms of intended use, materials of construction, and technological characteristics to predicate ventricular catheters which have been reviewed as central nervous system fluid shunt devices.
Device Description:
The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume. The device is supplied sterile and is intended for one-time use. The materials comprising the device have an established history of use in medical product manufacturing.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently manufactured and marketed by COOK INCORPORATED. This device is similar with respect to indications for use, materials and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
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§ 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).