(284 days)
No
The device description details a purely mechanical system based on fluid dynamics and valve operation, with no mention of software, algorithms, or learning capabilities.
Yes
The device is described as a component of hydrocephalus shunt systems designed to shunt CSF. Shunting CSF from the brain to manage hydrocephalus is a therapeutic intervention. Furthermore, the device is designed to reduce hazards of excessive lowering of intraventricular pressure, which directly impacts patient health and well-being.
No
The device is designed to control the flow of CSF, not to diagnose a condition. It is a component of a shunt system used to manage hydrocephalus.
No
The device description clearly details a physical, implantable device with mechanical components (ball-in-seat valve, spiral passage, rigid shell) designed to control CSF flow. It is not software.
Based on the provided information, the SiphonGuard™ CSF Control Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of hydrocephalus shunt systems designed to shunt CSF from the brain to other parts of the body. This is a therapeutic and mechanical function, not a diagnostic one.
- Device Description: The description details the mechanical operation of the device in controlling CSF flow. It does not describe any process of analyzing biological samples (like CSF) to provide diagnostic information.
- Lack of Diagnostic Function: The device's purpose is to manage the flow of CSF to prevent complications related to pressure changes, not to diagnose a condition or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, or CSF) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SiphonGuard™ CSF Control Device does not perform this function.
N/A
Intended Use / Indications for Use
The SiphonGuard™ CSF Control Device is a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.
The SiphonGuard™ CSF Control Device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
Product codes
JXG
Device Description
The SiphonGuard™ CSF Control Device is a siphon control device that is designed with two internal passages. The primary passage is a ruby ball-in-seat valve design that opens and closes depending on the CSF flow rate. The secondary passage is a longer spiral passage that remains permanently open but effectively slows the progress of the CSF through the device. The device has two basic modes of operation:
- Normal CSF Flow Conditions: Majority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and rejoins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
- Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.
As long as CSF continues to be shunted from the ventricles, flow through the secondary passage never stops, regardless of patient position. The rigid device shell prevents inadvertent closure of the device by externally applied pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, peritoneal cavity, right atrium of the heart
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
Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate.
Key Metrics
Not Found
Predicate Device(s)
K902783, preamendment
Reference Device(s)
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
Exhibit I
510(k) Summary SiphonGuard™ CSF Control Device
K99217
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
-
- Contact Person:
Laura O'Grady Requlatory Affairs Specialist (508) 828-3164
- Contact Person:
2. Device Information:
SiphonGuard™ CSF Control Device Proprietary Name: Common Name: Antisiphon Device Classification Name: Central Nervous system Fluid Shunt and Components Regulatory Class: Class II by 21 CFR §882.5550 Product Code: JXG
3. Indications for Use:
The SiphonGuard™ CSF Control Device is a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.
The SiphonGuard™ CSF Control Device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
1
4. Device Description:
The SiphonGuard™ CSF Control Device is a siphon control device that is designed with two internal passages. The primary passage is a ruby ball-in-seat valve design that opens and closes depending on the CSF flow rate. The secondary passage is a longer spiral passage that remains permanently open but effectively slows the progress of the CSF through the device. The device has two basic modes of operation:
- Normal CSF Flow Conditions: Maiority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and reioins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
- Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.
As long as CSF continues to be shunted from the ventricles, flow through the secondary passage never stops, regardless of patient position. The rigid device shell prevents inadvertent closure of the device by externally applied pressure.
5. Performance:
Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate.
6. Substantial Equivalence:
The substantial equivalence of the SiphonGuard™ CSF Control Device to predicate products, is substantiated by its similarity in intended use, design, and performance to the Delta® Valve (K902783), and Transquard™ device (preamendment), as well as by the use of the identical materials used in the CODMAN HAKIM™ Micro Precision Valve (K973774).
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
APR 7 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura O'Grady, RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K992173
Trade Name: SiphonGuard™ CSF Control Device Regulatory Class: II Product Code: JXG Dated: January 7, 2000 Received: January 10, 2000
Dear Ms. O'Grady:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Laura O'Grady, RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Donna R. Lochner.
( A Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) Device Name
992173 SiphonGuard™ CSF Control Device
Indications For Use
The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.
The SiphonGuard™ device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Duane R. Vorhies.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_k 992173
Prescription Use ✓ (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)