(110 days)
Radionics Contour Flex Valve, PS Medical Burr Hole Valve
Not Found
No
The description focuses on the mechanical design and function of a cerebrospinal fluid shunt valve, with no mention of AI or ML.
Yes
The device is indicated for the treatment of hydrocephalus by draining fluid from the brain, which qualifies it as a therapeutic intervention.
No
Explanation: This device is described as a "cerebrospinal fluid shunt" and is used for "the treatment of hydrocephalus" by draining fluid. Its purpose is therapeutic, not diagnostic.
No
The device description clearly describes a physical implantable device (Burr Hole Valve) designed to fit into a burr hole and shunt cerebrospinal fluid. It mentions materials like polypropylene and silicone membrane, indicating hardware components.
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 draining cerebrospinal fluid from the brain ventricles to another part of the body. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description details a physical device designed to be implanted and manage fluid flow within 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 (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Burr Hole 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 is designed to fit into a formal burr hole. The Radionics Burr Hole Valve is indicated for the treatment of hydrocephalus. It is a device The Racebook and fluid from the ventricles of the brain to an appropriate drainage ate, such as the atrium of the heart or the peritoneal cavity. The Burr Hole Valve is designed to fit into a formal burr hole.
Product codes
84JXG
Device Description
The Burr Hole Valve is designed for use as a cerebrospinal fluid shum. It is the commercially available Radionics Contour Flex membrane valve with an alternate shaped reservoir/ pumping chamber; the Burr Hole Valve is shaped to fit into a burr hole. The Radionics Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. The Radionics Burr Hole Valve has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. Both of these valves are designed in two sizes to fit a 12 mm and 16 mm burr hole. The fluid flow path is the same for the Radionics Burr Hole Valve and the Contour Flex Valve. In addition, the flow control element is the same for the Burr Hole and Contour Flex Valves. The same polypropylene base/ silicone membrane valve component is used in both systems resulting in the same pressure flow specifications for each type of valve.
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
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Radionics Contour Flex Valve, PS Medical Burr Hole Valve
Reference Device(s)
Not Found
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
Summary of Safety and Effectiveness Page 4 JUN - 4 1997 General Information Class II Classification: Central nervous system fluid shunt component Common Name: Radionics Burr Hole Valve Device Trade Name: The Burr Hole Valve is designed to shunt cerebrospinal fluid Intended Uses: from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. It is designed to fit into a formal burr hole. Radionics Contour Flex Valve and PS Medical Burr Hole Predicate Device: Valve Radionics, Inc. Establishment Name and Address: 22 Terry Avenue Burlington, MA 01803 Linda Jalbert, (617) 272-1233 Contact Name and Phone: Establishment registration number: 1219140 None established under Section 514 Performance Standard:
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 Burr Hole 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 promote safe and effective use of the device, when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
The Burr Hole Valve is designed for use as a cerebrospinal fluid shum. It is the commercially available Radionics Contour Flex membrane valve with an alternate shaped reservoir/ pumping chamber; the Burr Hole Valve is shaped to fit into a burr hole. The Radionics Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. The Radionics Burr Hole Valve has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. Both of these valves are designed in two sizes to fit a 12 mm and 16 mm burr hole. The fluid flow path is the same for the Radionics Burr Hole Valve and the Contour Flex Valve. In addition, the flow control element is the same for the Burr Hole and Contour Flex Valves. The same polypropylene base/ silicone membrane valve component is used in both systems resulting in the same pressure flow specifications for each type of valve.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of three overlapping human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Ms. Linda Jalbert Manager, Requlatory Affairs Radionics Instruments; Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K970578 Trade Name: Radionics Burr Hole Valve Regulatory Class: II Product Code: 84JXG Dated: May 12, 1997 Received: May 13, 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, labelinq, 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 Druq 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 miqht 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications For Use:
Indications for Use
The Radionics Burr Hole Valve is indicated for the treatment of hydrocephalus. It is a device The Racebook and fluid from the ventricles of the brain to an appropriate drainage ate, such as the atrium of the heart or the peritoneal cavity. The Burr Hole Valve is designed to fit into a formal burr hole.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Cleeves
(Division Sign Off)
Division Sion-C Division of Cardiovascular and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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Over The Counter Use
(Optional Format 1-2-96)
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