(87 days)
Radionics Contour Flex Valve and Contour Flex Plus Valve
Not Found
No
The summary describes a mechanical valve with a siphon limiting device and mentions an alternate material for the housing. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
This device is designed to treat hydrocephalus by shunting cerebrospinal fluid, which directly addresses a medical condition.
No
The description clearly states that the device is for treatment (shunting cerebrospinal fluid) and does not mention any diagnostic capabilities.
No
The device description clearly describes physical valves (Contour Flex and Contour Flex Plus Valves) designed to shunt cerebrospinal fluid, indicating a hardware medical device. The 510(k) is specifically for an alternate material for the upper housing of these valves, further confirming it is a hardware modification.
Based on the provided information, 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 performed directly on the patient.
- Device Description: The device is a valve designed to be implanted in the body to manage fluid flow.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Contour Flex and Contour Flex Plus Valves are medical devices used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Contour Flex and Contour Flex Plus Valves 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 atrium of the heart or the peritoneal cavity. The Contour Flex Plus Valve 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)
84JXG
Device Description
The Contour Flex Valve and Contour Flex Plus Valve are designed for use as a cerebrospinal fluid shunts. The Contour Flex Plus Valve is the Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon 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 an alternate material for the upper housing of these valves. This material was subjected to and passes biocompatability testing like the unmodified commercially available valves, designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the alternate material to confirm valve performance. There is no change to the design, dimensions, or specifications of the valves with the use of the alternate material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, atrium of the heart or the peritoneal cavity
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 alternate material 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 Valve and Contour Flex Plus Valve
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
JUL 2 4 1997
Summary of Safety and Effectiveness
| General Information | |
|---|---|
| Classification: | Class II |
| Common Name: | Central nervous system fluid shunt component |
| Device Trade Name: | Radionics Contour Flex Valve and 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. | |
| Predicate Device: | Radionics Contour Flex Valve and Contour Flex Plus Valve |
| Establishment Name and Address: | Radionics, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | Linda Jalbert (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 Valve and Contour Flex Plus 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 Contour Flex Valve and Contour Flex Plus Valve are designed for use as a cerebrospinal fluid shunts. The Contour Flex Plus Valve is the Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon 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 an alternate material for the upper housing of these valves. This material was subjected to and passes biocompatability testing like the unmodified commercially available valves, designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the alternate material to confirm valve performance. There is no change to the design, dimensions, or specifications of the valves with the use of the alternate material.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1997
Ms. Linda Jalbert Manager, Regulatory Affairs Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K971511 Trade Name: Radionics Contour Flex Valve and Contour Flex Plus Valve Requlatory Class: II Product Code: 84JXG Dated: April 25, 1997 Received: April 28, 1997
Dear Ms. Jalbert:
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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
Paqe 2 - Ms. Linda Jalbert
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) 594-4648. 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:____ Radionics Contour Flex Valve and Contour Flex Plus Valve
Indications For Use:
The Contour Flex and Contour Flex Plus Valves 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 atrium of the heart or the peritoneal cavity. The Contour Flex Plus Valve 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Callifon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K991511
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)