(87 days)
Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.
The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Integra Camino Advanced Monitor (K962928 Integra LifeSciences Corporation) or to Integra Camino ICP Monitor (K121573 Integra LifeSciences Corporation).
The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter.
The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.
The Integra Camino Flex Ventricular Catheter in an MR environment is for conditional use in 1.5 Tesla (T) and 3.0 T MR Environments. The conditions for safe use are:
- · Not to exceed a maximum head or whole body averaged specific absorption rate (SAR) of 2 Watts/kg.
- · Not to exceed maximum scan duration of 15 minutes.
- · Circularly coil the externalized portions of the catheter within a 2.5 inch (6.3cm) to 3.5 inch (8.8cm) diameter range and securely tape it over the top of the patient's head.
- · Use only the following coils for MRI procedures:
- o Transmit Body/Receive Body RF Coils
- o Transmit Body Coils with any Receive-Only Coil (including receive-only head coils)
- · Do not use transmit head coils for MRI procedures
- · None of the catheter accessories, such as the trocar, stylet, drill stop and hex wrench should be brought into the MR environment. These accessories are only required during catheter placement and not needed in the MR environment.
Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text:
This submission (K133754) is a labeling modification to add MR safety information for the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device's compatibility and safety within an MR environment, not its primary function of ICP monitoring. The core functionality and performance related to ICP monitoring are assumed to be consistent with the predicate device as there are no changes to the product itself.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (MR Safety) | Reported Device Performance (as stated in labeling and non-clinical data) |
|---|---|
| Conditional MR Use: Safe for use in 1.5 Tesla (T) and 3.0 Tesla (T) MR Environments. | The Integra Camino Flex Ventricular Catheter is for conditional use in 1.5 T and 3.0 T MR Environments. |
| Maximum SAR (Specific Absorption Rate): Not to exceed a maximum head or whole body averaged SAR of 2 Watts/kg. | Confirmed through testing to be safe under this condition. (Implied by "All necessary testing has been completed... and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met.") |
| Maximum Scan Duration: Not to exceed 15 minutes. | Confirmed through testing to be safe under this condition. (Implied by "All necessary testing has been completed... and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met.") |
| Catheter Coiling: Circularly coil externalized portions of the catheter within a 2.5 inch (6.3cm) to 3.5 inch (8.8cm) diameter range and securely tape it over the top of the patient's head. | This is a required condition for safe use. (Implied by "The conditions for safe use are:" followed by this instruction and "Testing confirmed that the ... Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling.") |
| Permitted MRI Coils: Only Transmit Body/Receive Body RF Coils or Transmit Body Coils with any Receive-Only Coil (including receive-only head coils) are to be used. | These are the required coils for MRI procedures. (Implied by "The conditions for safe use are:" followed by this instruction and "Testing confirmed that the ... Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling.") |
| Prohibited MRI Coils: Do not use transmit head coils for MRI procedures. | This is a prohibited condition for MRI procedures. (Implied by "The conditions for safe use are:" followed by this instruction and "Testing confirmed that the ... Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling.") |
| Accessory Removal from MR Environment: None of the catheter accessories (trocar, stylet, drill stop, hex wrench) should be brought into the MR environment. | This is a required condition for safe use. (Implied by "The conditions for safe use are:" followed by this instruction and "Testing confirmed that the ... Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling.") |
| Ability of the device to continue to perform its intended function of ICP monitoring and CSF drainage after MR exposure while adhering to safety conditions. | "Testing was performed to ensure that the device met pre-defined performance and safety specifications and to ensure that hazard mitigations functioned as designed." This implies that the device maintained its core functionality for ICP monitoring and CSF drainage while proving MR safety. |
| Substantial equivalence to predicate device in terms of safety and effectiveness for its intended use, especially given the labeling modification. | "Testing confirmed that the Integra 'Camino' Flex Ventricular Intracranial Pressure Monitoring Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical tests" and "Magnetic Resonance testing only to demonstrate MR compatibility for the catheter." It does not specify a sample size for a test set that would typically involve human patients or clinical data. The testing appears to be entirely bench-top or laboratory-based to evaluate MR compatibility. Therefore, questions of country of origin or retrospective/prospective do not apply in the usual sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not provided in the document. Given that the study is a non-clinical, MR compatibility test for a labeling modification, the "ground truth" would be established by engineering and physics principles of MR safety and device integrity, rather than expert clinical interpretation of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as this was not a study involving human readers or clinical data requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers in that capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This study is not evaluating an algorithm or AI performance. It is evaluating the physical and electrical compatibility of a medical catheter with an MR environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this study is based on engineering and physics principles related to Magnetic Resonance (MR) safety and compatibility standards. This would involve measurements of induced heating, image artifact assessment, and force/torque assessments as per relevant MR safety standards (e.g., ASTM F2503). The document broadly states "Testing confirmed that the Integra 'Camino' Flex Ventricular Intracranial Pressure Monitoring Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling."
8. The sample size for the training set
Not applicable. This study does not involve machine learning algorithms or a training set.
9. How the ground truth for the training set was established
Not applicable. This study does not involve machine learning algorithms or a training set.
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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 | 781-565-1347 |
| Fax Number | 781-238-0645 |
| Establishment RegistrationNumber | 3003418325 |
| Name of Contact Person | Elizabeth McMeniman, Senior Regulatory Affairs Specialist |
| Date Prepared | December 6, 2013 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | Integra™ Camino® Flex Ventricular Intracranial PressureMonitoring Kit (for Catheter and Accessories) |
| Common or Usual Name | Ventricular CatheterIntracranial Pressure Monitoring System |
| Classification Name | Device, Monitoring, Intracranial Pressure |
| Classification Panel | Neurology |
| Regulation | Class II, under 21 CFR 882.1620 |
| Product Code(s) | GWM |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™Camino® Flex Adapter K121159 | |
| 807.92(a)(4) - Device description | |
| The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit functions as an |
entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Integra Camino Advanced Monitor (K962928 Integra LifeSciences Corporation) or to Integra Camino ICP Monitor (K121573 Integra LifeSciences Corporation).
The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is
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comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter.
The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.
The Integra Camino Flex Ventricular Catheter in an MR environment is for conditional use in 1.5 Tesla (T) and 3.0 T MR Environments. The conditions for safe use are:
- · Not to exceed a maximum head or whole body averaged specific absorption rate (SAR) of 2 Watts/kg.
- · Not to exceed maximum scan duration of 15 minutes.
- · Circularly coil the externalized portions of the catheter within a 2.5 inch (6.3cm) to 3.5 inch (8.8cm) diameter range and securely tape it over the top of the patient's head.
- · Use only the following coils for MRI procedures:
- o Transmit Body/Receive Body RF Coils
- o Transmit Body Coils with any Receive-Only Coil (including receive-only head coils)
- · Do not use transmit head coils for MRI procedures
- · None of the catheter accessories, such as the trocar, stylet, drill stop and hex wrench should be brought into the MR environment. These accessories are only required during catheter placement and not needed in the MR environment.
| Indications for Use | Use of the IntegraTM Camino® Flex Ventricular IntracranialPressure Monitoring is indicated when direct and continuousintraventricular intracranial pressure (ICP) monitoring andcerebrospinal fluid (CSF) drainage are required. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The Integra "Camino" Flex Ventricular Intracranial Pressure Monitoring Kit is a labeling modification to add MR safety information to the product labeling. The technological characteristics are the same as there is no change to the product except for labeline.
The Integra " Camino " Flex Ventricular Intracranial Pressure Monitoring Kit and the predicate device have the same device classification, product code and measureable parameters as outlined in the substantial equivalence chart and discussion.
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807.92(b)(1-2) - Nonclinical tests submitted
The Integra "Camino" Flex Ventricular Catheter was tested in accordance with the relevant test plans/reports included in the 510(k) submission. Testing was performed to ensure that the device met pre-defined performance and safety specifications and to ensure that hazard mitigations functioned as designed.
Testing includes Magnetic Resonance testing only to demonstrate MR compatibility for the catheter.
807.92(b)(3) - Conclusions drawn from non-clinical data
All necessary testing has been completed for the Integra " Camino" Flex Ventricular Intracranial Pressure Monitoring Catheter and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed that the Integra "Camino" Flex Ventricular Intracranial Pressure Monitoring Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling and is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Ms. Elizabeth McMeniman Senior Regulatory Affairs Specialist Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
Re: K133754
Trade/Device Name: Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring System Regulatory Class: Class II Product Code: GWM Dated: December 6, 2013 Received: December 9, 2013
Dear Ms. McMeniman:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Elizabeth McMeniman
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133754
Device Name
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit
Indications for Use (Describe)
Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
13011 443-6
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§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).