(52 days)
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.
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.
This report outlines the acceptance criteria and study details for the LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems, as described in the provided 510(k) summary (K072929).
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it refers to substantial equivalence to a predicate device and lists general areas of testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Integrity | Adhesion/Bond Strength: Tested for strength of bonded components. Performance indicates components maintain integrity under expected use. |
| Fluid Containment | Leakage: Tested for leakage. Performance indicates no unintended fluid escape. |
| Drainage Functionality | Drainage: Tested for proper drainage. Performance indicates efficient and controlled CSF removal. |
| Volume Limiting Mechanism | Sealing Mechanism Performance: Tested to ensure the valve, mounted on the float, rises with fluid and seals when the nominal volume is reached, effectively limiting collected CSF volume. |
| Packaging Robustness | Package Integrity: Tested to ensure sterile barrier and protection of the device until use. Performance indicates packaging is intact and protective. |
| Safety Features | Needlestick Injury Reduction: Needleless sampling sites designed to reduce needlestick injuries and subsequent exposure to infected fluids. (No specific performance metric provided, but design addresses the risk). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be bench testing performed by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The tests performed ("strength of bonded components, leakage, drainage, sealing mechanism performance and package integrity") are typically objective engineering tests and do not require expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
As the tests are objective engineering assessments and no human interpretation of results is indicated, no adjudication method (like 2+1 or 3+1) was employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned. The device is a physical medical device for fluid drainage, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm was performed. The device is a physical, mechanical system for CSF drainage, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests performed was based on engineering specifications and functional requirements for a medical device of this type. For example, "leakage" or "drainage" performance would be measured against predefined acceptable tolerances and flow rates. The "sealing mechanism performance" would be verified against the design intent of limiting fluid volume.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/algorithm-based product, the concept of a "training set" is not applicable. The device design is based on engineering principles and prior predicate devices.
9. How Ground Truth for the Training Set Was Established
Since there is no training set for an algorithm, this question is not applicable. The design and safety validations were established through engineering specifications, laboratory testing, and comparison to the predicate device (MoniTorr™ External CSF Drainage and Monitoring Systems) for substantial equivalence.
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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 Drainageand 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
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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 |
|---|---|
| --------------- | ---------- |
§ 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).