(109 days)
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.
The LimiTorr™ 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 to monitor ICP.
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems provide a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainaqe bag. The system may be used with a pole mounted assembly that allows alignment with the patient and secure positive or neqative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion.
The LimiTorr™ External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached.
Both drainage systems are provided sterile and connect to either ventricular or lumbar catheters (not included in this submission) via a luer connection to a patient line and ultimately to a drainage bag. The indications for use of both MoniTorr and LimiTorr remain unchanged with this submission.
The intent of this 510(k) is to notify FDA of Integra's intent to implement a new stopcock component, make minor dimensional modifications to the stopcock manifold and to add a precaution to the Instruction for Use (IFU) concerning not over-tightening or applying excessive force to the luer lock/fluid filled transducer. The stopcocks control the flow of CSF to allow drainage from the patient, or allow flow to a pressure transducer to determine the intracranial pressure (ICP) of the patient. The stopcocks may be used to allow extraction of CSF from patient line for patient sampling. The proposed stopcock is a 4-way stopcock, with standard port connections, which are both characteristics of the predicate stopcock. The proposed stopcock maintains the same luer port internal diameter as the predicate.
The provided document describes the acceptance criteria and supporting studies for the Integra LifeSciences MoniTorr ICP External CSF Drainage and Monitoring System and LimiTorr Volume Limiting External CSF Drainage and Monitoring System. This submission focuses on changes to a stopcock component and a labeling precaution, asserting substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document details various performance bench tests and biocompatibility tests performed on the new stopcock component. The acceptance criterion for all these tests is that the device (with the new stopcock) meets current specifications, demonstrating substantial equivalence to the predicate.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Torque to Failure | Average torque to failure within current specifications. | All results passed. |
| Average Peak Moment | Average peak moment within current specifications. | All results passed. |
| Peak Tensile Force to overcome bond strength | Average tensile force to remove bonded tubing within specifications. | All results passed. |
| Resistance to Flow | Resistance to flow within current specifications. | All results passed. |
| Leakage Test | Pressure decay in patient line within current specifications. | All results passed. |
| 30 Day functionality test for LimiTorr and MoniTorr (Torque to Failure, Peak Moment, Peak Tensile Force) | Continued to meet current specifications after 30 days. | All results passed. |
| Design Validation | Meets user needs, can be operated safely and effectively. | All results passed. |
| Cytotoxicity ISO Elution Method | No cytotoxicity or cell lysis. | Non-cytotoxic. |
| ISO Guinea Pig Maximization Sensitization | No delayed dermal contact sensitization. | Non-sensitizing. |
| ISO Intracutaneous Study in Rabbits | Met requirements for non-irritation. | Non-irritating. |
| ISO Acute Systemic Toxicity Study in Mice | No mortality, clinically normal, acceptable body weight. | Non-toxic acutely. |
| USP Rabbit Material-Mediated Pyrogenicity | Absence of pyrogens. | Non-pyrogenic. |
| ASTM Hemolysis | Hemolytic index of 0.0%. | Non-hemolytic. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific numerical 'sample sizes' for each individual performance test (e.g., number of stopcocks tested for torque to failure). It broadly states that "Testing was successfully completed for all protocols above."
For biocompatibility testing, it is stated that the "device tested (Safeport with Handle) is identical to the proposed stopcock," indicating that the biocompatibility data was leveraged from the stopcock vendor. The provenance of this data is therefore external, coming from the vendor's testing. The nature of these tests (e.g., testing on samples of the material or components) implies they are retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a 510(k) submission for device modifications based on non-clinical (bench and biocompatibility) testing, not a study involving human interpretation or diagnoses where "experts" would establish "ground truth" in the clinical sense. Therefore, this information is not applicable. The "ground truth" here is defined by the established industry standards and internal specifications for medical devices.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a non-clinical device modification submission, not a study requiring adjudication of human-interpreted data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared to the predicate devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Study Was Done
Not applicable. This device is not an AI/algorithm-based diagnostic tool. It is a physical medical device (fluid drainage and monitoring system).
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance and biocompatibility studies is based on:
- Current specifications: Internal design specifications, engineering requirements, and functional parameters set by the manufacturer.
- Established standards: Adherence to recognized international standards like ISO 10993-1 for biocompatibility and other relevant industry standards for medical device performance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
October 11, 2019
Integra LifeSciences Corporation Omayra Ramirez Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K191684
Trade/Device Name: MoniTorr ICP External CSF Drainage and Monitoring System: LimiTorr Volume Limiting External CSF Drainage and Monitoring System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: September 9, 2019 Received: September 10, 2019
Dear Omayra Ramirez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D., M.S. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191684
Device Name
MoniTorr ICPTM External CSF Drainage and Monitoring System LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Indications for Use (Describe)
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.
The LimiTor™ 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 to monitor ICP.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| 807.92(a)(1) – Submitter information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive Plainsboro, NJ 08536 USA |
| Phone Number | 1-609-275-0500 |
| Establishment Registration Number | 9004007 |
| Name of Contact Person | Omayra Ramirez |
| Date Prepared | September 6, 2019 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | LimiTorr™ Volume Limiting External CSF Drainageand Monitoring SystemMoniTorr ICP™ External CSF Drainage and MonitoringSystem |
| Common or Usual Name | External Cerebrospinal Fluid Drainage and MonitoringSystem |
| Classification Name | Central Nervous System Shunt and Components |
| Classification Panel | Neurology |
| Regulation | Class II, 21 CFR 882.5550 |
| Product Code(s) | JXG |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| MoniTorr ICP™ External Drainage and Monitoring Systems; K920156 / K022554 | |
| LimiTorr™ Volume Limiting External CSF Drainage Systems; K072929 |
{4}------------------------------------------------
807.92(a)(4) - Device description
MoniTorr:
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems provide a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainaqe bag. The system may be used with a pole mounted assembly that allows alignment with the patient and secure positive or neqative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion.
LimiTorr:
The LimiTorr™ External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached.
Both drainage systems are provided sterile and connect to either ventricular or lumbar catheters (not included in this submission) via a luer connection to a patient line and ultimately to a drainage bag. The indications for use of both MoniTorr and LimiTorr remain unchanged with this submission.
The intent of this 510(k) is to notify FDA of Integra's intent to implement a new stopcock component, make minor dimensional modifications to the stopcock manifold and to add a precaution to the Instruction for Use (IFU) concerning not over-tightening or applying excessive force to the luer lock/fluid filled transducer. The stopcocks control the flow of CSF to allow drainage from the patient, or allow flow to a pressure transducer to determine the intracranial pressure (ICP) of the patient. The stopcocks may be used to allow extraction of CSF from patient line for patient sampling. The proposed stopcock is a 4-way stopcock, with standard port connections, which are both characteristics of the predicate stopcock. The proposed stopcock maintains the same luer port internal diameter as the predicate.
{5}------------------------------------------------
Integra LifeSciences Corporation -Traditional 510(k)
MoniTorr ICP™ External Drainage and Monitoring Systems
LimiTorr™ Volume Limiting External CSF Drainage Systems
| 807.92(a)(5) – Intended use of the device | 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.The LimiTorr™ 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 to monitor ICP. |
|---|---|
| Indications for Use | |
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate |
{6}------------------------------------------------
The proposed MoniTorr ICP™ and LimiTorr™ External Drainage Systems with the new stopcock and additional precaution to the labeling have the same technological characteristics compared to the predicate devices. Other than the proposed stopcock and labeling change, there are no other changes to the MoniTorr or LimiTorr devices. Furthermore, the implementation of the new stopcock component to both systems and the addition of a new precaution to the labeling does not alter the indications for use, intended use, manufacturing and sterilization process, or the fundamental scientific technology of the devices. Both the predicate and proposed stopcocks use substantially equivalent materials (HDPE and polycarbonate) and the same lubricant. Table 1 provides a comparison of the predicate and proposed devices.
| Table 1: Comparison of Subject and Predicate Devices | |||
|---|---|---|---|
| Property | Subject Devices | Predicates | Comments |
| Indications | The MoniTorr ICPTM systemallows for drainage and monitoringof CSF from the lateral ventriclesof the brain and the lumbarsubarachnoid space in selectedpatients to reduce intracranialpressure (ICP), to monitor CSF, toprovide temporary drainage ofCSF in patients with infected CSFshunts, and the monitoring of ICP.The LimiTorrTM system allows fordrainage and monitoring of CSFfrom the lateral ventricles of thebrain and the lumbarsubarachnoid space in selectedpatients to reduce intracranialpressure (ICP), to monitor CSF, toprovide temporary drainage ofCSF in patients with infected CSFshunts, and to monitor ICP. | Same | Same as predicate |
| StopcockMaterials | Handle Core: HDPEBody material:PolycarbonateLubricant: Dow Medical Fluid | Handle Core: HDPEBody material:PolycarbonateLubricant: Dow Medical Fluid | The predicate andproposed stopcock usethe same base materials,including the samelubricant, only theviscosity is different.Biocompatibility testingdemonstrates complianceto ISO 10993-1 andtherefore the materials donot raise new questions ofsafety and effectiveness. |
| Stopcock LuerportInternal diameter | 0.168 in | 0.168 in | Same |
| Flow path (innerdiameter) of thestopcock | Minimum 0.065 in(Nominal 0.085 in) | 0.075 ± 0.005 inNominal 0.075 in | Flow path specification iswithin specification of thepredicate device.Performance testingsupports that flowperformance is not impactedby the new stopcock innerdiameter. The minordifferences in the innerdiameter of the device flowpath between the predicateand subject devices do notraise new questions of safetyand effectiveness. |
| 4-way stopcock(Yes/No) | Yes | Yes | Same |
| Standard femaleLuer Port(Yes/No) | Yes | Yes | Same |
| ManifoldBore dimension | 0.343 ± 0.002 in | 0.392 ± 0.001 in | A dimensional change to themanifold cavity where thestopcock is bonded wasrequired because of the newstopcock. Performancetesting and processverification supports that thisdimensional change doesnot raise new questions ofsafety and effectiveness. |
| SterilityInformation | Provide Sterile, single use. EOsterilized 10 -6 | Provide Sterile, single use.EO sterilized 10 -6 | Same as predicate |
| PackagingConfiguration | Double Tyvek/ Mylar Pouch andwhite corrugated box | Double Tyvek/ Mylar Pouchand white corrugated box | Same as Predicate |
{7}------------------------------------------------
Integra LifeSciences Corporation -Traditional 510(k)
MoniTorr ICP™ External Drainage and Monitoring Systems
LimiTorr™ Volume Limiting External CSF Drainage Systems
{8}------------------------------------------------
| Table 2: Performance Bench Test Results | ||
|---|---|---|
| Test | Test Summary | Results |
| Torque to Failure | To determine if the average torque tofailure for the stopcock for LimiTorr andMoniTorr ICP are within currentspecifications. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| Average PeakMoment | To determine if the average peak momentof the LimiTorr and MoniTorr ICP stopcockis within current specifications. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| Peak Tensile Forceto overcome bondstrength | To determine if the average tensile forcerequired to remove the bonded tubing fromthe stopcock is within current specifications. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| Resistance to Flow | To determine if the resistance to flow of thedevice is within current specifications. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| Leakage Test | To determine if the pressure decay in thepatient line is within current specifications. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| 30 Day functionalitytest for LimiTorr andMoniTorr | To determine if the stopcock/tubingassembly for LimiTorr and MoniTorr ICPcontinue to meet current specifications fortorque to failure, peak moment, and peaktensile force to overcome bond strengthafter 30 days of simulated use. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
| Design Validation | To confirm that the MoniTorr ICP andLimiTorr External CSF Drainage Systemsmeet the user needs, and that the systemcan be operated as intended, safely andeffectively. | All results passed,demonstrating substantialequivalence of the proposeddevice. |
{9}------------------------------------------------
In addition to bench testing, biocompatibility testing was leverage from the stopcock vendor. The device tested (Safeport with Handle) is identical to the proposed stopcock having the same chemical formulations, same surface properties, same manufacturing, and same sterilization processes. Furthermore, there are no additional materials added to the stopcock during Integra's manufacturing process. The biocompatibility testing is summarized in Table 3.
| Table 3: Biocompatibility Test Summary | ||
|---|---|---|
| Test | Results | Conclusions |
| Cytotoxicity ISO Elution Method | No cytotoxicity or cell lysis in any of the testwells | Non-cytotoxic |
| ISO Guinea Pig MaximizationSensitization | Test article extracts showed no evidence ofcausing delayed dermal contactsensitization in the guinea pig. | Non-sensitizing |
| ISO Intracutaneous Study inRabbits | The test article met the requirements of thetest since the difference between each testarticle extract overall mean score andcorresponding control extract overall meanscore was 0.0 and 0.1 for the SC and SOtest article extracts, respectively. | Non-irritating |
| ISO Acute Systemic Toxicity Studyin Mice | No mortality during the studyAll animals were clinically normal throughout the studyBody weight data were acceptable | Non-toxic acutely |
| USP Rabbit Material-MediatedPyrogenicity | The test article met the requirements for theabsence of pyrogens. No single animalshowed a temperature rise of 0.5°C or moreabove its baseline temperature. The totalrise of the rabbits' temperature during the 3hour observation period was 0.2°C. | Non-pyrogenic |
| ASTM Hemolysis | The hemolytic index for the test article indirect contact with blood was 0.0%, and thehemolytic index for the test article extractwas 0.0%. | Non-hemolytic |
Testing was successfully completed for all protocols above and supports the conclusion that all product specifications and design inputs have been met. Integra LifeSciences therefore believes verification and validation testing results for the proposed MoniTorr support a determination of substantial equivalence when compared to the predicate devices.
No clinical studies were performed or required as all conducted performance tests appropriately support a
{10}------------------------------------------------
determination of substantial equivalence compared to the predicate devices.
807.92(b)(3) – Conclusions drawn from non-clinical and clinical data
The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the MoniTorr and LimiTorr are substantially equivalent to the predicate devices.
§ 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).