RADIONICS SIPHON LIMITING DEVICE (SLD)

K962990 · Radionics, Inc. · JXG · Oct 23, 1996 · Neurology

Device Facts

• Record ID: K962990
• Device Name: RADIONICS SIPHON LIMITING DEVICE (SLD)
• Applicant: Radionics, Inc.
• Product Code: JXG · Neurology
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As a component of a cerebrospinal fluid shunt system, the SLD prevents over-drainage of CSF due to siphoning.

Device Story

Radionics Siphon Limiting Device (SLD) functions as a component within a cerebrospinal fluid (CSF) shunt system; prevents over-drainage caused by siphoning when ventricular catheter is elevated relative to distal catheter. Device utilizes a flexible diaphragm that opens or closes in response to changes in hydrostatic pressure; inlet and outlet ports facilitate fluid flow. Used in clinical settings by neurosurgeons during shunt implantation or revision. Output is mechanical regulation of CSF flow; assists in maintaining appropriate intracranial pressure; benefits patient by reducing risks associated with overdrainage.

Clinical Evidence

No clinical data provided; device relies on design and functional equivalence to the predicate device.

Technological Characteristics

Mechanical flow control device; features inlet and outlet ports with a flexible diaphragm; operates via hydrostatic pressure-sensitive mechanical actuation; no electronic components or software.

Indications for Use

Indicated for patients requiring cerebrospinal fluid shunt systems to prevent over-drainage caused by siphoning effects when the ventricular catheter is elevated relative to the distal catheter.

Regulatory Classification

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.

Predicate Devices

• PS Medical Siphon Control Device

Submission Summary (Full Text)

{0}

X962990
OCT 23 1996
Page 4

# Summary of Safety and Effectiveness

## 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. [phone] |
| 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.