(92 days)
Not Found
Not Found
No
The device description is purely mechanical and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is used to drain fluid to relieve elevated intracranial pressure, which is a therapeutic intervention.
No
The device is described as being used to "drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume," which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a "Ventricular Catheter Set" and describes physical components used to access a ventricular cavity and drain fluid. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain access to a ventricular cavity of the brain to drain fluid externally". This is a surgical/interventional procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The description focuses on the physical function of the device in accessing and draining fluid from the brain, not on analyzing biological samples.
Therefore, the Ventricular Catheter Set is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
84JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular cavity of the brain
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)
Not Found
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
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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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