(88 days)
Radionics Contour Flex Valve, PS Medical Delta CSF Flow Control Valve
Not Found
No
The device description focuses on mechanical components (membrane valve, siphon limiting device, flexible diaphragm) and their function based on hydrostatic pressure, with no mention of AI or ML.
Yes
The device is designed to shunt cerebrospinal fluid, a medical intervention to treat a condition (hydrocephalus), which is a therapeutic purpose.
No
The device is a shunt designed to manage cerebrospinal fluid flow, not to diagnose a condition.
No
The device description clearly describes a physical valve and associated components designed to shunt cerebrospinal fluid, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to a drainage site. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description details a mechanical valve and siphon limiting device for managing fluid flow within the body.
- Anatomical Site: The device is implanted in the ventricles of the brain.
- 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 any such testing.
The device is a medical device used for treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Contour Flex Plus Valve is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. It also prevents over-drainage of CSF due to siphoning.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Contour Flex Plus Valve is designed for use as a cerebrospinal fluid shunt. It is the commercially available Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). The Radionics Contour Flex Plus Valve is a single unit which combines the features of the Contour Flex Valve and Siphon Limiting Device into a single, smaller unit for the surgeon's convenience. The Contour Flex Plus Valve has the same intended use and design characteristics as the PS Medical Delta CSF Flow Control Valve. Its valve component is the same as the Radionics Contour Flex Valve. Both the Radionics Contour Flex Plus Valve and the PS Medical Delta CSF Flow Control Valve have a siphon limiting device with an outlet port and a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles 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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Radionics Contour Flex Valve and PS Medical Delta CSF Flow Control Valve
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 3 | 1997
Summary of Safety and Effectiveness
Page 4
| General Information | |
|---|---|
| Classification: | Class II |
| Common Name: | Central nervous system fluid shunt component |
| Device Trade Name: | Radionics Contour Flex Plus Valve |
| Intended Uses: | The Contour Flex Plus Valve is designed to shunt |
| cerebrospinal fluid from the ventricles of the brain to an | |
| appropriate drainage site, such as the atrium of the heart or | |
| the peritoneal cavity. It also prevents over-drainage of CSF | |
| due to siphoning. | |
| Predicate Device: | Radionics Contour Flex Valve and PS Medical Delta CSF |
| Flow Control Valve | |
| Establishment Name and Address: | Radionics, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | Michael Arnold, Ph.D. (617) 272-1233 |
| Establishment registration number: | 1219140 |
| Performance Standard: | None established under Section 514 |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Safety Summary
The labeling for the Radionics Contour Flex Plus contains instructions for the proper use of this device. The labeling includes a description of the product, directions for use, and applicable safety information including contraindications, precautions, and warnings. These instructions ensure safe and effective use of the device when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
The Contour Flex Plus Valve is designed for use as a cerebrospinal fluid shunt. It is the commercially available Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). The Radionics Contour Flex Plus Valve is a single unit which combines the features of the Contour Flex Valve and Siphon Limiting Device into a single, smaller unit for the surgeon's convenience. The Contour Flex Plus Valve has the same intended use and design characteristics as the PS Medical Delta CSF Flow Control Valve. Its valve component is the same as the Radionics Contour Flex Valve. Both the Radionics Contour Flex Plus Valve and the PS Medical Delta CSF Flow Control Valve have a siphon limiting device with an outlet port and a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.