INTEGRA CAMINO ICP MONITOR

K121573 · Intrgra Lifesciences Corporation · GWM · Sep 10, 2012 · Neurology

Device Facts

• Record ID: K121573
• Device Name: INTEGRA CAMINO ICP MONITOR
• Applicant: Intrgra Lifesciences Corporation
• Product Code: GWM · Neurology
• Decision Date: Sep 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.

Device Story

The Integra Camino ICP Monitor is a compact, portable device used by neurosurgeons or neurointensivists in clinical settings to monitor intracranial pressure (ICP) and intracranial temperature (ICT). It accepts input signals from connected fiberoptic or strain gauge catheters placed directly in the brain. The device processes these signals to display real-time numeric ICP and temperature values, as well as real-time ICP waveforms on a touch screen. It stores mean ICP trend data for up to 5 days. Data can be exported to external memory, streamed to a PC via USB, or sent to bedside monitors via analog output. Healthcare providers use this information to assess patient status and guide clinical decision-making regarding neurological treatment. The device benefits patients by providing continuous, accurate monitoring of critical intracranial parameters.

Clinical Evidence

Bench testing only. Testing included ICP and temperature accuracy, alarm performance, trend functionality, data export, fault testing, electromagnetic compatibility, electrical safety, environmental testing, and cleaning validation. Results confirmed the device meets all design inputs and specifications.

Technological Characteristics

Portable monitor with touch screen interface. Supports fiberoptic and strain gauge catheters. Provides numeric and waveform displays for ICP and temperature. Connectivity includes USB for data streaming/export and analog output for bedside monitors. Operates via signal translation from connected catheters. Tested for electrical safety and electromagnetic compatibility.

Indications for Use

Indicated for qualified neurosurgeons or neurointensivists for the measurement of intracranial pressure and temperature in patients requiring such monitoring.

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

• Camino® Multi Parameter Monitor (K962928)

Submission Summary (Full Text)

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K12 1573

SEP 1 0 2012

| 807.92(a)(1) - Submitter Information | |
|---------------------------------------------------------------------------|---------------------------------------------|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive<br>Plainsboro NJ 08536 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment<br>Registration Number | 3003418325 |
| Name of Contact Person | Erin Doyle |
| Date Prepared | May 25, 2012 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | Integra™ Camino® ICP Monitor |
| Common or Usual Name | Intracranial pressure monitor |
| Classification Name . | Intracranial pressure monitoring device |
| 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 | |
| Camino® Multi Parameter Monitor - K962928 | |

510(k) Summary

#### 807.92(a)(4) - Device description

The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters.

The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP trend data stored on the Monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.

## 807.92(a)(5) -- Intended Use of the device

| Indications for Use | The Integra Camino ICP Monitor is indicated for use by<br>qualified neurosurgeons or neurointensivists for<br>measurement of intracranial pressure and temperature. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|

807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The design of both the modified device and the predicate device is similar. Both of the devices receive signals from the catheters that are then translated into the intracranial pressure & temperature reading. These readings are then displayed on the screen for the health care practitioners to use as additional information in treatment of the patient.

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Integra™ Camino® ICP Monitor and the predicate device have similar intended uses, indications for use, technology, environment for use, device classifications, product codes and measureable parameters as outlined in the substantial equivalence chart and discussion. There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

| Product<br>Characteristics | Comparison Integra™ Camino® ICP Monitor to the<br>predicate Camino® Multi Parameter Monitor |
|------------------------------------|------------------------------------------------------------------------------------------------|
| Parameter Display | Similar |
| Data Output | Similar |
| Bedside Output | Similar |
| System Performance<br>Requirements | Similar |
| Alarms | Similar |
| Parameter Indicators | Similar |
| User Inputs | Integra™ Camino® ICP Monitor - Touch screen Camino® Multi Parameter Monitor - Membrane Buttons |
| Portability and<br>Handling | Similar |

# 807.92(b)(1-2) - Nonclinical Tests Submitted

The Integra Camino ICP Monitor tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market. Testing was performed to ensure that the device met requirements specifications and to ensure that hazard mitigations functioned as intended.

Testing includes but is not limited to the following:

- . ICP Accuracy
- Temperature Accuracy ●
- . Alarm setting, accuracy, volume etc.
- . Trend functionality
- Data Export Functionality (bedside monitor, external storage) .
- . Fault testing
- Electromagnetic Compatibility ●
- Electrical Safety .
- . Environmental Testing
- Cleaning Testing

# 807.92(b)(3) - Conclusions drawn from non-clinical data

All necessary testing has been completed for the Integra Camino ICP Monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed The Integra Camino ICP Monitor is safe and effective under the proposed conditions of use and is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 10 2012

Integra LifeSciences Corporation % Mr. Erin Doyle Regulatory Affairs Associate 311 Enterprise Drive Plainsboro, NJ 08536

Re: K121573

Trade Name: Integra™ Camino® ICP Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: August 2, 2012 Received: August 3, 2012

Dear Mr. Doyle:

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 r lease of acreased 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 or any I vith 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

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## Page 2 - Mr. Erin Doyle

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Evdelman, M.D. Director

Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 12157-3

#### Indications for Use

510(k) Number (if known): K121573

.

Device Name:

# Integra™ Camino® ICP Monitor

Indications For Use:

The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.

Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AC

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K121573 510(k) Number

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