INTEGRA LICOX PTO2 MONITOR

K131184 · Integra Lifesciences Corp. · GWM · Aug 30, 2013 · Neurology

Device Facts

• Record ID: K131184
• Device Name: INTEGRA LICOX PTO2 MONITOR
• Applicant: Integra Lifesciences Corp.
• Product Code: GWM · Neurology
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Integra Licox PtO2 Monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Device Story

Integra Licox PtO2 Monitor is a diagnostic instrument for continuous monitoring of brain tissue oxygen partial pressure (PtO2) and temperature. Minimally invasive probes are implanted in brain tissue and connected to the monitor. The device processes signals from probes to calculate PtO2 and temperature, displaying numeric values on a screen. It features 5-day trend data storage, USB data export, and analog output for bedside monitors. Operated by neurosurgeons, nurses, intensivists, or trauma physicians in hospital settings. The device provides supplemental data to assist clinicians in assessing cerebral perfusion status; it is not intended as the sole basis for diagnosis or therapy. Benefits include continuous monitoring of oxygenation status in patients at risk of hypoxia or ischemia.

Clinical Evidence

Bench testing only. Testing included PtO2 and temperature accuracy, alarm verification, trend functionality, data export, fault testing, electromagnetic compatibility, electrical safety, environmental testing, and cleaning validation. Results confirmed the device met all design inputs and performance specifications.

Technological Characteristics

Diagnostic monitor for PtO2 and temperature; uses minimally invasive brain tissue probes. Features GUI screen, USB port for data export, and analog output for bedside integration. Pole-mountable form factor. Software-based data processing and storage (5-day trend). Sterilization not specified for monitor (probes are sterile).

Indications for Use

Indicated for patients where hypoxia or ischemia are a concern, requiring continuous monitoring of brain tissue oxygen partial pressure (PtO2) and temperature to aid in determining cerebral tissue perfusion status.

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

• LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems (K002765)
• LICOX PMO BRAIN MONITORING SYSTEM (K040235)
• INTEGRA CAMINO ICP MONITOR (K121573)
• INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER (K121159)

Submission Summary (Full Text)

{0}------------------------------------------------

K131184

#### 510(k) Summary

| 807.92(a)(1) - Submitter Information | |
|---------------------------------------------------------------------------|-----------------------------------------|
| Name | Integra LifeSciences Corporation |
| Address | 22 Terry Avenue<br>Burlington, MA 01830 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment Registration Number | 1222895 |
| Name of Contact Person | Elizabeth McMeniman |
| Date Prepared | April 26, 2013 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | Integra® Licox® PtO2 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 | |

LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems - K002765 .

- LICOX PMO BRAIN MONITORING SYSTEM- K040235 .
- INTEGRA CAMINO ICP MONITOR- K121573 .
- . INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER- K121159

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

The Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor.

The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the 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 Licox PtO₂ monitor measures oxygen partial pressure<br>(PtO2) and temperature in brain tissue and these parameters are used<br>together as an aid in the determination of the perfusion status of<br>cerebral tissue local to sensor placement. Monitor values are<br>relative within an individual, and should not be used as the sole basis<br>for determining a diagnosis or therapy. It is intended to provide<br>data additional to that obtained by current clinical practice in cases<br>where hypoxia or ischemia are a concern. |
| AUG 3 0 2013 | |

{1}------------------------------------------------

| Intended Users | The operation of the Licox PtO₂ monitor is to be performed by designated qualified hospital staff (i.e. neurosurgeon, nurse, intensivist, trauma physician, physician's assistant, or other appropriately trained staff). |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

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

Integra Licox PrO2 monitor and the predicate device have intended uses, environment for use, device classifications, product codes and measureable parameters as outlined in the substantial equivalence chart and discussion. Any differences in the technological characteristics of the new device do not raise different questions of safety and effectiveness than the predicate device. .

| Product Characteristics | Comparison Integra® Licox® PtO₂ Monitor to the predicate | |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | LICOX Brain Oxygen Monitoring System, CMP® Monitor | |
| Parameter Display | | |
| PtO2 Trend (5 day) Display | The predicate Licox CMP Monitoring System does not trend<br>PtO2 data. | |
| Trend Data Storage | The predicate Licox CMP Monitoring System does not trend or<br>store PtO2 data. | |
| Trend Data Retention | The predicate Licox CMP Monitoring System does not retain<br>data specific to the probe. | |
| Data Output | The predicate Licox CMP Monitoring System does not include<br>a USB port. | |
| System PtO₂ Performance<br>Requirements | Same | |
| Alarms | The predicate Licox CMP Monitoring System does not have a<br>Low PtO2 Alarm or a Low Battery Alarm | |
| Parameter Indicators | Same | |
| User Inputs via GUI screen | The predicate Licox CMP Monitor used a key pad. | |
| Portability and Handling | The predicate Licox CMP Monitor cannot be mounted to a pole.<br>The proposed Licox PtO2 monitor can be mounted to a pole<br>with diameter between 0.5 and 1.2 inches outer diameter. | |
| Bedside Output | Same | |
| 807.92(b)(1-2) - Nonclinical Tests Submitted | | |

The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units.

Testing was performed to ensure that the device met pre-defined performance and safety specifications and to ensure that hazard mitigations functioned as designed.

{2}------------------------------------------------

Testing includes, but is not limited to the following:

- . PtO2 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 Licox PtO2 monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed that the Integra Licox PtO2 monitor is safe and effective under the proposed conditions of use and is substantially equivalent to the predicate device.

{3}------------------------------------------------

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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

#### 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

August 30, 2013

Integra LifeSciences Corporation % Ms. Elizabeth McMeniman Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, NJ 08536

Re: K131184

> Trade/Device Name: Integra® Licox® PtO2 Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: July 26, 2013 Received: July 29, 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

{4}------------------------------------------------

Page 2 - Ms. Elizabeth McMeniman

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 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/Medica]Devices/ResourcesforYou/Industry/default,htm.

Sincerely yours,

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): K131184

Device Name: Integra® Licox® PtO2 Monitor

Indications For Use:

The Integra Licox PtO2 Monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K131184

Page 1 of 1