(90 days)
The Cordis Ventricular Antechamber (VA) is a component of a central nervous system (CNS) fluid shunt. It connects the ventricular catheter to the valve's integral tubing. In this configuration, it serves to conduct cerebrospinal fluid (CSF) from this catheter to the valve. It may also be used with a ventricular catheter alone. In either configuration, the VA facilitates CSF sampling.
The Cordis Ventricular Antechamber is manufactured from silicone elastomer (with/without barium sulfate), polysulfone and polypropylene impregnated with barium sulfate.
This submission describes a medical device, the Cordis Ventricular Antechamber (VA), which is a component of a central nervous system (CNS) fluid shunt. The document focuses on establishing substantial equivalence to predicate devices and detailing biocompatibility.
Critically, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any study design involving statistical analysis, sample sizes, expert ground truth, or comparative effectiveness with or without AI assistance.
Therefore, I cannot fulfill your request for the specific information points you've outlined. The text provided is a regulatory submission for a Class II medical device, primarily addressing its intended use, description, classification, and substantial equivalence to existing predicate devices based on design, materials, and manufacturing methods, along with biocompatibility. It does not include performance study data in the context you've described.
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SECTION - 2 SUMMARY AND CERTIFICATION
(Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act)
Trade (proprietary) Name 1.
Cordis Ventricular Antechamber (VA)
Common/Classification Name 2.
Ventricular Antechamber/Central nervous system fluid shunt and components
Applicant's Name and Address 3.
Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Classification 4.
This device is classified as Class II (21 CFR 882.5550)
5. Predicate Devices
Cordis Orbis Sigma Valve (OSV) Cordis Polypropylene Burr Hole Reservoirs Cordis CSF Reservoir Cordis Right Angle Guide Cordis Right Angle Catheter Cordis Polypropylene Straight, "Y" & "T" Connectors
Performance Standards 6.
No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
7. Intended Use and Device Description
The Cordis Ventricular Antechamber (VA) is a component of a central nervous system (CNS) fluid shunt. It connects the ventricular catheter to the valve's integral tubing. In this configuration, it serves to conduct cerebrospinal fluid (CSF) from this catheter to the valve. It may also be used with a ventricular catheter alone. In either configuration, the VA facilitates CSF sampling. The Cordis Ventricular Antechamber is manufactured from silicone elastomer (with/without barium sulfate), polysulfone and polypropylene impregnated with barium sulfate.
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Biocompatibility 8.
The materials used to manufacture the Cordis Ventricular Antechamber have been subjected to biocompatibility testing and are safe for their intended use.
Summary of Substantial Equivalence': 9.
The indications and contraindications of the Cordis Ventricular Antechamber are the same as those for the predicate Cordis antechambers. The design, materials, manufacturing methods and specifications of the Cordis Ventricular Antechamber are equivalent to those of the predicate devices and do not raise any new issues relating to safety and effectiveness for its intended use.
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
§ 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).