(109 days)
Not Found
No
The device description and performance studies focus on mechanical components and fluid dynamics, with no mention of AI/ML algorithms or data processing for decision-making or analysis. The changes described are related to a stopcock component and dimensional modifications.
Yes.
The device is used to reduce intracranial pressure and monitor cerebrospinal fluid, which are therapeutic interventions.
Yes
The device is explicitly stated to "monitor CSF" and "monitor ICP," and also allows for flow to "a pressure transducer to determine the intracranial pressure (ICP) of the patient," all of which are diagnostic functions.
No
The device description clearly details physical components like drainage bags, tubing, stopcocks, and a pole-mounted assembly, indicating it is a hardware-based system for CSF drainage and monitoring.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on drainage and monitoring of CSF from the brain and lumbar space to reduce intracranial pressure, monitor CSF, and provide temporary drainage. This is a therapeutic and monitoring function performed in vivo (within the patient's body).
- Device Description: The device is described as a "closed system for the drainage of cerebrospinal fluid (CSF)" and a "volume limiting external CSF drainage system." It connects to catheters inserted into the patient. This further reinforces its function as an in vivo device for managing CSF.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or CSF) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis or testing of the CSF itself; it simply drains and allows for pressure monitoring. While it mentions the possibility of extracting CSF for sampling, the device's primary function is not the in vitro analysis of that sample.
Therefore, the MoniTorr ICP™ and LimiTorr™ systems, as described, are medical devices used in vivo for drainage and monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MoniTorr ICPTM 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain and the 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)
Bench Test Results:
- Torque to Failure: All results passed, demonstrating substantial equivalence of the proposed device.
- Average Peak Moment: All results passed, demonstrating substantial equivalence of the proposed device.
- Peak Tensile Force to overcome bond strength: All results passed, demonstrating substantial equivalence of the proposed device.
- Resistance to Flow: All results passed, demonstrating substantial equivalence of the proposed device.
- Leakage Test: All results passed, demonstrating substantial equivalence of the proposed device.
- 30 Day functionality test for LimiTorr and MoniTorr: All results passed, demonstrating substantial equivalence of the proposed device.
- Design Validation: All results passed, demonstrating substantial equivalence of the proposed device.
Biocompatibility Test Summary (leveraged from stopcock vendor):
- Cytotoxicity ISO Elution Method: No cytotoxicity or cell lysis in any of the test wells. Conclusion: Non-cytotoxic.
- ISO Guinea Pig Maximization Sensitization: Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Conclusion: Non-sensitizing.
- ISO Intracutaneous Study in Rabbits: The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. Conclusion: Non-irritating.
- ISO Acute Systemic Toxicity Study in Mice: No mortality during the study. All animals were clinically normal throughout the study. Body weight data were acceptable. Conclusion: Non-toxic acutely.
- USP Rabbit Material-Mediated Pyrogenicity: The test article met the requirements for the absence of pyrogens. No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during the 3 hour observation period was 0.2°C. Conclusion: Non-pyrogenic.
- ASTM Hemolysis: The hemolytic index for the test article in direct contact with blood was 0.0%, and the hemolytic index for the test article extract was 0.0%. Conclusion: Non-hemolytic.
No clinical studies were performed or required.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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)
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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 Drainage |
| and Monitoring System | |
| MoniTorr ICP™ External CSF Drainage and Monitoring | |
| System | |
| Common or Usual Name | External Cerebrospinal Fluid Drainage and Monitoring |
| System | |
| 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 |
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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 | |
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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 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 LimiTorrTM 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. | Same | Same as predicate |
| Stopcock
Materials | Handle Core: HDPE
Body material:
Polycarbonate
Lubricant: Dow Medical Fluid | Handle Core: HDPE
Body material:
Polycarbonate
Lubricant: Dow Medical Fluid | The predicate and
proposed stopcock use
the same base materials,
including the same
lubricant, only the
viscosity is different.
Biocompatibility testing
demonstrates compliance
to ISO 10993-1 and
therefore the materials do
not raise new questions of
safety and effectiveness. |
| Stopcock Luer
port
Internal diameter | 0.168 in | 0.168 in | Same |
| Flow path (inner
diameter) of the
stopcock | Minimum 0.065 in
(Nominal 0.085 in) | 0.075 ± 0.005 in
Nominal 0.075 in | Flow path specification is
within specification of the
predicate device.
Performance testing
supports that flow
performance is not impacted
by the new stopcock inner
diameter. The minor
differences in the inner
diameter of the device flow
path between the predicate
and subject devices do not
raise new questions of safety
and effectiveness. |
| 4-way stopcock
(Yes/No) | Yes | Yes | Same |
| Standard female
Luer Port
(Yes/No) | Yes | Yes | Same |
| Manifold
Bore dimension | 0.343 ± 0.002 in | 0.392 ± 0.001 in | A dimensional change to the
manifold cavity where the
stopcock is bonded was
required because of the new
stopcock. Performance
testing and process
verification supports that this
dimensional change does
not raise new questions of
safety and effectiveness. |
| Sterility
Information | Provide Sterile, single use. EO
sterilized 10 -6 | Provide Sterile, single use.
EO sterilized 10 -6 | Same as predicate |
| Packaging
Configuration | Double Tyvek/ Mylar Pouch and
white corrugated box | Double Tyvek/ Mylar Pouch
and 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 to | |
| failure for the stopcock for LimiTorr and | ||
| MoniTorr ICP are within current | ||
| specifications. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| Average Peak | ||
| Moment | To determine if the average peak moment | |
| of the LimiTorr and MoniTorr ICP stopcock | ||
| is within current specifications. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| Peak Tensile Force | ||
| to overcome bond | ||
| strength | To determine if the average tensile force | |
| required to remove the bonded tubing from | ||
| the stopcock is within current specifications. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| Resistance to Flow | To determine if the resistance to flow of the | |
| device is within current specifications. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| Leakage Test | To determine if the pressure decay in the | |
| patient line is within current specifications. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| 30 Day functionality | ||
| test for LimiTorr and | ||
| MoniTorr | To determine if the stopcock/tubing | |
| assembly for LimiTorr and MoniTorr ICP | ||
| continue to meet current specifications for | ||
| torque to failure, peak moment, and peak | ||
| tensile force to overcome bond strength | ||
| after 30 days of simulated use. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. | ||
| Design Validation | To confirm that the MoniTorr ICP and | |
| LimiTorr External CSF Drainage Systems | ||
| meet the user needs, and that the system | ||
| can be operated as intended, safely and | ||
| effectively. | All results passed, | |
| demonstrating substantial | ||
| equivalence of the proposed | ||
| device. |
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 test | |
| wells | Non-cytotoxic | |
| ISO Guinea Pig Maximization | ||
| Sensitization | Test article extracts showed no evidence of | |
| causing delayed dermal contact | ||
| sensitization in the guinea pig. | Non-sensitizing | |
| ISO Intracutaneous Study in | ||
| Rabbits | The test article met the requirements of the | |
| test since the difference between each test | ||
| article extract overall mean score and | ||
| corresponding control extract overall mean | ||
| score was 0.0 and 0.1 for the SC and SO | ||
| test article extracts, respectively. | Non-irritating | |
| ISO Acute Systemic Toxicity Study | ||
| in Mice | No mortality during the studyAll animals were clinically normal throughout the studyBody weight data were acceptable | Non-toxic acutely |
| USP Rabbit Material-Mediated | ||
| Pyrogenicity | The test article met the requirements for the | |
| absence of pyrogens. No single animal | ||
| showed a temperature rise of 0.5°C or more | ||
| above its baseline temperature. The total | ||
| rise of the rabbits' temperature during the 3 | ||
| hour observation period was 0.2°C. | Non-pyrogenic | |
| ASTM Hemolysis | The hemolytic index for the test article in | |
| direct contact with blood was 0.0%, and the | ||
| hemolytic index for the test article extract | ||
| was 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
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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.