INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER

K133754 · Integra LifeSciences Corporation · GWM · Mar 6, 2014 · Neurology

Device Facts

• Record ID: K133754
• Device Name: INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
• Applicant: Integra LifeSciences Corporation
• Product Code: GWM · Neurology
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit is a single-use, disposable system for intraventricular ICP monitoring and CSF drainage. The system consists of a flexible catheter with a pressure-sensing tip, a tensile member, an electrical connection to a monitor, and a drainage lumen for connection to an extraventricular drainage (EVD) device. The catheter is implanted into the anterior horn of the lateral cerebral ventricle via a tunneling surgical method. The device connects to the Integra Camino Advanced Monitor or Integra Camino ICP Monitor. The system is MR conditional for 1.5T and 3.0T environments under specific SAR and scan duration constraints. The device provides continuous pressure data to the monitor, allowing clinicians to observe ICP levels and manage CSF drainage, which aids in clinical decision-making for patients with neurological conditions requiring intracranial pressure management.

Clinical Evidence

Bench testing only. Testing focused on MR compatibility to demonstrate safety in 1.5T and 3.0T environments. No clinical data was required or submitted.

Technological Characteristics

Flexible catheter with pressure-sensing tip, tensile member, and drainage lumen. MR conditional (1.5T/3.0T). Connects to external ICP monitors via adapter/extension cable. Single-use, disposable. Designed for tunneling surgical implantation.

Indications for Use

Indicated for patients requiring direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage.

Regulatory Classification

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.

Predicate Devices

• Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter (K121159)

Reference Devices

• Integra Camino Advanced Monitor (K962928)
• Integra Camino ICP Monitor (K121573)

Submission Summary (Full Text)

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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 Registration<br>Number | 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 Pressure<br>Monitoring Kit (for Catheter and Accessories) |
| Common or Usual Name | Ventricular Catheter<br>Intracranial 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™<br>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 Intracranial<br>Pressure Monitoring is indicated when direct and continuous<br>intraventricular intracranial pressure (ICP) monitoring and<br>cerebrospinal fluid (CSF) drainage are required. |
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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 [phone] or [phone] 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 [phone] or [phone] 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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