K964386 · Radionics, Inc. · JXG · Jan 31, 1997 · Neurology
Device Facts
Record ID
K964386
Device Name
RADIONICS CONTOUR FLEX PLUS VALVE
Applicant
Radionics, Inc.
Product Code
JXG · Neurology
Decision Date
Jan 31, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.5550
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
Cerebrospinal fluid (CSF) shunt component; manages hydrocephalus by diverting CSF from ventricles to atrium or peritoneal cavity. Integrates existing Contour Flex membrane valve with Siphon Limiting Device (SLD) into single unit. SLD uses flexible diaphragm and outlet port to respond to hydrostatic pressure changes; prevents over-drainage caused by siphoning when patient changes position (sitting/standing). Used by neurosurgeons in clinical/surgical settings. Output is mechanical regulation of CSF flow; assists clinical decision-making by maintaining intraventricular pressure stability. Benefits patient by reducing complications associated with overdrainage.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Mechanical CSF shunt valve; integrates membrane valve and siphon limiting device. Features flexible diaphragm and outlet port. Operates via hydrostatic pressure-responsive mechanical actuation. Single-unit form factor.
Indications for Use
Indicated for patients requiring cerebrospinal fluid shunting from brain ventricles to drainage sites (atrium or peritoneal cavity) to manage hydrocephalus and prevent over-drainage due to siphoning.
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
Radionics Contour Flex Valve
PS Medical Delta CSF Flow Control Valve
Submission Summary (Full Text)
{0}
JAN 31 1997
K964386
# Summary of Safety and Effectiveness
## 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.
