(83 days)
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Not Found
No
The device description focuses on a mechanical mechanism (flexible diaphragm) responding to hydrostatic pressure, with no mention of AI/ML terms or data-driven processes.
Yes
The SLD is a component of a cerebrospinal fluid (CSF) shunt system and its function is to prevent over-drainage of CSF due to siphoning, which indicates it is used for a medical purpose to manage a physiological function.
No
The device description indicates that the SLD prevents over-drainage of CSF and limits the siphoning effect, which are active control or treatment functions, not diagnostic ones. There is no mention of measurement, analysis, or detection of a condition.
No
The device description clearly states it is a physical device with an inlet, outlet, and flexible diaphragm, indicating it is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as preventing over-drainage of CSF due to siphoning as a component of a cerebrospinal fluid shunt system. This is a therapeutic or physiological function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of the device (limiting siphoning effect, flexible diaphragm opening/closing based on hydrostatic pressure). This aligns with a medical device used within the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to regulate fluid flow within a shunt system, which is a direct intervention on the body's physiology.
N/A
Intended Use / Indications for Use
As a component of a cerebrospinal fluid shunt system, the SLD prevents over-drainage of CSF due to siphoning.
Product codes
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Device Description
The SLD is a device that limits the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter. It has the same intended use and design characteristics as the PS Medical Siphon Control Device (SCD). Both the Radionics SLD and the PS Medical SCD have an inlet and outlet port, as well as a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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.)
Not Found
Predicate Device(s)
PS Medical Siphon Control Device
Reference Device(s)
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).
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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).
0
OCT 23 1996
Summary of Safety and Effectiveness
Page 4
| General Information | |
|---|---|
| Classification: | Class II |
| Common Name: | Central nervous system fluid shunt component |
| Device Trade Name: | Radionics Siphon Limiting Device (SLD) |
| Intended Uses: | As a component of a cerebrospinal fluid shunt system, the SLD prevents over-drainage of CSF due to siphoning. |
| Predicate Device: | PS Medical Siphon Control Device |
| 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 SLD contains instructions for the proper use of this device. The labeling includes a description of the product, directions for use, and applicable safety information. 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 SLD is a device that limits the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter. It has the same intended use and design characteristics as the PS Medical Siphon Control Device (SCD). Both the Radionics SLD and the PS Medical SCD have an inlet and outlet port, as well as a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.