(52 days)
Not Found
No
The device description focuses on mechanical components (burette, stopcock, valve, float) for volume limiting and drainage, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies also focus on physical properties and function.
Yes
The device is used to reduce intracranial pressure and provide temporary drainage of CSF, which are therapeutic interventions.
Yes
The device is used to monitor CSF and ICP, which are diagnostic activities.
No
The device description clearly outlines physical components such as catheters, luer connections, patient lines, drainage bags, burettes, stopcocks, and a volume limiting mechanism with a valve and float. These are all hardware components, indicating the device is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to drain and monitor cerebrospinal fluid (CSF) from the patient's body (lateral ventricles and lumbar subarachnoid space) to reduce intracranial pressure, monitor CSF, and provide temporary drainage. This is a direct interaction with the patient's physiological system.
- Device Description: The device is a system for external drainage and monitoring of CSF. It involves catheters, lines, a burette, and a drainage bag. This describes a system for managing fluid within the body and collecting it externally.
- Lack of In Vitro Activity: An IVD is designed to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device does not perform any analysis or testing on the collected CSF to diagnose or monitor a condition based on the properties of the fluid itself. It simply collects and measures the volume.
The device is a medical device used for managing and monitoring a physiological process within the patient's body, not for analyzing a specimen in a laboratory setting.
N/A
Intended Use / Indications for Use
The LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems allow 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 LimiTorr™ Volume Limiting 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 subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag.
These systems are designed for single use only.
The Limitorr™ Volume Limiting External CSF Drainage and Monitoring Systems include a mechanism designed to limit the volume of CSF colleted to a nominal volume. The volume limiting mechanism consists of a valve mounted to the top of the float that rises as the fluid collects in the burette and seals when the nominal volume is reached.
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 systems have been tested for strength of bonded components, leakage, drainage, sealing mechanism performance and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems
510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536
DEC = 7 2007
Ko72929
Contact person and telephone number:
Darlene M. Welsh, RAC Manager, Regulatory Affairs Telephone: 609-936-2307 Facsimile: 609-275-9445
Date summary was prepared:
October 15, 2007
Name of the device:
| Proprietary Name: | LimiTorr™ Volume Limiting External CSF Drainage
and Monitoring Systems |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | External Cerebrospinal Fluid Drainage and Monitoring System |
| Classification Name: | Central Nervous System Shunt and Components JXG |
Substantial Equivalence:
The LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems are substantially equivalent in function and intended use to the unmodified MoniTorr™ External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 510(k) K022554.
Intended use:
The LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems allow 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 LimiTorr™ Volume Limiting 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
1
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 subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag.
These systems are designed for single use only.
Safety
The Limitorr™ Volume Limiting External CSF Drainage and Monitoring Systems include a mechanism designed to limit the volume of CSF colleted to a nominal volume. The volume limiting mechanism consists of a valve mounted to the top of the float that rises as the fluid collects in the burette and seals when the nominal volume is reached
The systems have been tested for strength of bonded components, leakage, drainage, sealing mechanism performance and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids.
Conclusion
The LimiTorr™ Volume Limiting External CSF Drainage System is substantially equivalent to the unmodified MoniTorr ICP™ system. These modifications do not affect the intended use, the fundamental scientific technology of the device and doe not raise new issues of safety and effectiveness
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OEC = 7 2007
Integra Lifesciences Corporation % Ms. Darlenc M. Welsh, RAC Manager, Regulatory Affairs 311C Enterprise Drive Plainsboro, New Jersey 08536
Re: K072929
Trade/Device Name: LimiTorr™ Volume Limiting External Drainage and Monitoring Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: November 15, 2007 Received: November 16, 2007
Dear Ms. Welsh:
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
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Page 2 - Ms. Darlene M. Welsh, RAC
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.
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, permitts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliarice at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device acre vomments (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistantes o at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: K072929
Device Name: LimiTorr™ Volume Limiting External Drainage and Monitoring Systems
Indications for Use: The LimiTorr™ Volume Limiting External Drainage and Monitoring Systems allow 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 to monitor ICP.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation-(ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 14072929 |
|---|---|
| --------------- | ---------- |