(90 days)
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
Not Found
No
The summary describes a passive mechanical component of a fluid shunt system and makes no mention of AI, ML, or any computational processing.
No.
The device is a component of a fluid shunt system used to conduct cerebrospinal fluid, which facilitates CSF sampling, not to treat a disease or condition.
No
The device is described as a component of a CNS fluid shunt that conducts cerebrospinal fluid and facilitates CSF sampling, but it is not stated to be used for diagnosing medical conditions.
No
The device description explicitly states it is manufactured from physical materials like silicone elastomer, polysulfone, and polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct cerebrospinal fluid (CSF) and facilitate CSF sampling as part of a central nervous system (CNS) fluid shunt. This is a surgical implant/device used in vivo (within the body) to manage fluid flow.
- Device Description: The description details the materials used in the physical construction of the device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, test kits, or instruments that analyze biological samples like blood, urine, or tissue.
The device is a component of a medical device used for surgical implantation and fluid management within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central nervous system (CNS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
00-00004
K 955832
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.
1
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).