(21 days)
Not Found
No
The device description focuses on mechanical components for CSF drainage and monitoring, with no mention of AI or ML for data analysis, prediction, or control.
Yes
The device is intended to reduce intracranial pressure, which is a therapeutic intervention.
Yes
The intended use explicitly states "to monitor CSF" and "the monitoring of ICP," which are diagnostic functions.
No
The device description clearly details physical components like drainage bags, catheters, burettes, stopcocks, and vents, indicating it is a hardware-based medical device.
Based on the provided information, the MoniTorr ICP™ system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the drainage and monitoring of CSF, primarily to reduce intracranial pressure and provide temporary drainage. While it mentions monitoring CSF, the context is about the volume and pressure of the fluid within the body, not the analysis of the fluid's components or characteristics to diagnose a condition.
- Device Description: The description focuses on the physical components and function of the system for draining and measuring the volume of CSF. It describes a drainage bag, burette, stopcocks, and vents. These are all related to the mechanical handling and measurement of the fluid, not its chemical or biological analysis.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or CSF) outside the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The MoniTorr ICP™ system's primary function is to manage the fluid in situ and collect it externally for disposal or potentially for later analysis by a separate IVD device.
- Performance Studies: The performance studies mentioned focus on sterility, non-pyrogenicity, vent resistance to occlusion, tensile strength, pressure and leakage, drainage, and package integrity. These are all related to the physical and functional performance of a drainage system, not the analytical performance of a diagnostic test.
In summary, the MoniTorr ICP™ system is a medical device for managing and monitoring the physical properties (volume and pressure) of CSF within the body, not for performing diagnostic tests on CSF samples.
N/A
Intended Use / Indications for Use
The MoniTorr ICP™ system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
Product codes
JXG
Device Description
The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequestly emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the current MoniTorr ICPTM systems is being replaced with a vent that will allow better drainage of the CSF to the drainage bag and will better resist occlusion after contact with CSF. The antimicrobial media chosen for the vent is not compatible with the current method of sterilization, therefore, an alternate sterilization method, ethylene oxide has been chosen to sterilize the entire line of MoniTorr ICP™ systems. A vented cap will be used in place of the current closed end cap to allow flow of gas through the patient line. Additionally, the fluid path from the burette to the drainage bag has been enlarged and the current sampling sites are being replaced with needleless sampling sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, lumbar subarachnoid space
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)
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems have been shown to be sterile and non-pyrogenic. Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels. The antimicrobial media was subjected to an aerosol challenge with B.diminuta yielding a microbial retention of 10'. The MoniTorr ICP™ systems have been tested for tensile strength of bonded components, pressure and leakage, drainage, and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
microbial retention of 10'
Predicate Device(s)
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
AUG 2 3 2002
Confidential
22554/
MoniTorr ICP™ External CSF Drainage and Monitoring System
510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences 309 Commerce Drive Exton, PA 19341
Contact person and telephone number:
Donna R. Wallace Director, Regulatory Affairs (609) 275-0500
Date summary was prepared:
August 1, 2002
Name of the device:
| Proprietary Name: | MoniTorr ICPTM External CSF Drainage and Monitoring System |
|---|---|
| Common Name: | External Cerebrospinal Fluid Drainage and Monitoring System |
| Classification Name: | Central Nervous System Shunt and Components JXG |
Substantial Equivalence:
The MoniTorr ICP™ External CSF Drainage and Monitoring System is substantially equivalent in function and intended use to the unmodified MoniTorr™ External CSF Drainage and Monitoring System which has been cleared to market under Premarket Notification 510(k) K920156.
Intended use:
The MoniTorr ICP™ system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
Device Description:
The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequestly emptied into the drainage bag by opening the stopcock placed in
1
line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the current MoniTorr ICPTM systems is being replaced with a vent that will allow better drainage of the CSF to the drainage bag and will better resist occlusion after contact with CSF. The antimicrobial media chosen for the vent is not compatible with the current method of sterilization, therefore, an alternate sterilization method, ethylene oxide has been chosen to sterilize the entire line of MoniTorr ICP™ systems. A vented cap will be used in place of the current closed end cap to allow flow of gas through the patient line.
Additionally, the fluid path from the burette to the drainage bag has been enlarged and the current sampling sites are being replaced with needleless sampling sites.
Safety
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems have been shown to be sterile and non-pyrogenic. Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels. The antimicrobial media was subjected to an aerosol challenge with B.diminuta yielding a microbial retention of 10'. The MoniTorr ICP™ systems have been tested for tensile strength of bonded components, pressure and leakage, drainage, and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.
Conclusion
The MoniTorr ICP™ External CSF Drainage and Monitoring System is substantially equivalent to the unmodified MoniTorr ICP™ system. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2007
Integra NeuroSciences Donna R. Wallace Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K022554
Trade/Device Name: MoniTorr ICP™ External CSF Drainage and Monitoring System Regulation Number: 882.5550 Regulation Name: Central Nervous System Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 1, 2002 Received: August 2, 2002
Dear Ms. Wallace:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Donna R. Wallace
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mullenn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K022554 510(k) Number:
Device Name: MoniTorr ICP™ External Drainage and Monitoring Systems
Indications for Use:
The MoniTorr ICP™ system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801.109 | |
|---|---|
| Optional Format 1-2-96) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Or Over-the-Counter Use __________
for Mark N Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| C001 | 510(k) Number K022534 |
|---|---|
| ------ | ------------------------------ |