(405 days)
Not Found
Not Found
No
The description focuses on a mechanical valve and catheter system with a surface modification, and there is no mention of AI or ML in the text.
Yes
The device is intended for the treatment of hydrocephalus by shunting cerebrospinal fluid, which directly treats a medical condition.
No
This device is designed to shunt cerebrospinal fluid and treat hydrocephalus, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components (valve, ventricular catheter, peritoneal catheter) and their material properties and performance, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat hydrocephalus by shunting cerebrospinal fluid from the brain to another part of the body. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a cerebrospinal fluid shunt system consisting of a valve and catheters. These are physical devices implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity.
The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter are designed for use as a cerebrospinal fluid shunts. The Equi-Flow Valve with EZ-Coat is a 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). This 510(k) covers the use of a hydrophilic surface modification that has been incorporated into the commercially available Equi-Flow Valve and Catheters. This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance. There is no change to the designs. dimensions, or specifications of the valves with the use of the EZ-Coat surface modification.
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
Not Found
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)
Performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 Plus Valve and the Radionics Mini and Standard Shunt Valve Systems
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
Summary of Safety and Effectiveness
980903
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Central nervous system fluid shunt component |
| Device Trade Name: | Radionics Equi-Flow™ Valve with EZ-Coat™ |
| Radionics EZ-Coat™ Ventricular Catheter | |
| Radionics EZ-Coat™ Peritoneal Catheter | |
| Intended Uses: | The Equi-Flow™ Valve, Ventricular Catheter, and |
| Peritoneal Catheter with EZ-Coat™ are designed to shunt | |
| cerebrospinal fluid from the ventricles of the brain to an | |
| appropriate drainage site, such as the peritoneal cavity. | |
| Predicate Device: | Radionics Contour Flex Plus Valve and the Radionics |
| Mini and Standard Shunt Valve Systems | |
| Establishment Name and Address: | Radionics, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | Michael Arnold (781) 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 Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter contains instructions for the proper use of the 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 Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter are designed for use as a cerebrospinal fluid shunts. The Equi-Flow Valve with EZ-Coat is a 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). This 510(k) covers the use of a hydrophilic surface modification that has been incorporated into the commercially available Equi-Flow Valve and Catheters. This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance. There is no change to the designs. dimensions, or specifications of the valves with the use of the EZ-Coat surface modification.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 1999
Michael A. Arnold, Ph.D. Vice President Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
K980903 Re:
Trade Name: Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ Regulatory Class: II Product Code: JXG Dated: January 13, 1999 Received: January 19, 1999
Dear Dr. Arnold:
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.
2
Page 2 - Michael A. Arnold, Ph.D.
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,
f
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
3
980903
Indications for Use
The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.
Prescription Use (Per 21 CFR 801.109)
signature
(Division Sign-Off)
Division of General Restorative Devices, K980903
510(k) Number