LICOX PMO BRAIN MONITORING SYSTEM

K040235 · Integra LifeSciences Corporation · GWM · Apr 20, 2004 · Neurology

Device Facts

• Record ID: K040235
• Device Name: LICOX PMO BRAIN MONITORING SYSTEM
• Applicant: Integra LifeSciences Corporation
• Product Code: GWM · Neurology
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to 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

LICOX PMO Brain Oxygen Monitoring System monitors intracranial oxygen (PbtO2) and temperature; utilizes combined oxygen/temperature sensing probe (CC1.P1) inserted into brain parenchyma via introducer/bolt kit. System consists of disposable probe, PMO Interface Device, and cables. Operates via analog signal transmission; no microprocessor or screen on interface device; powered by battery or bedside monitor excitation voltage. Clinicians use output to track perfusion trends in patients with head trauma or post-craniotomy. Data serves as adjunct to clinical practice to identify potential hypoxia or ischemia; not for sole diagnostic or therapeutic decision-making. Benefits include early detection of secondary neurological insults.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per FDA G95-1 and ISO 10993. Performance testing confirmed probe design and system safety.

Technological Characteristics

Materials: Polyethylene (tissue-contacting). Sensing: Clark cell (O2), Type K thermocouple (temperature). Form factor: 0.65-1.3 mm diameter probe. Power: Battery or bedside monitor excitation. Connectivity: Analog output to bedside monitor. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients with head trauma or undergoing craniotomy who are at risk for cerebral hypoxia or ischemia. Used as an adjunct monitor for intracranial oxygen and temperature trends.

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 (K002765)
• LICOX Brain Oxygen Monitoring System (K020558)

Submission Summary (Full Text)

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K040235

## LICOX PMO Brain Oxygen Monitoring System, 510 (K) SUMMARY

#### Submitter's name and address:

Integra LifeSciences, dba Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

#### Contact person and telephone number:

Nancy A. Mathewson, Esq. Director, Regulatory Affairs [phone] ext. 185

#### Date summary was prepared:

January 29, 2004

#### Name of the device:

Proprietary Name: Common Name: Classification Name: LICOX PMO Brain Oxygen Monitoring System Brain Oxygen and temperature monitoring device Intracranial Pressure Monitoring Device, 21 CFR 882.1620, 84GWM Neurology Device Panel

Classification Panel:

## Substantial Equivalence:

The features of the LICOX PMO System are substantially equivalent to those of a legally marketed predicate device, the LICOX Brain Oxygen Monitoring System, which was cleared to market under 510(k) K002765 and 510(k) K020558.

Both devices were designed and are manufactured by the same company, GMSmbH, Kiel-Mielkendorf, Germany, which is an Integra LifeSciences/Integra NeuroSciences Company.

#### Device Description:

The LICOX PMO System consists of a combined oxygen and temperature probe, the PMO Interface Device and cranial access accessories. The following is a list of products covered by this submission, grouped into the following categories: Disposables, PMO Interface Device and associated cables. The list does not

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include minor accessories such as cables or convenience kits that are combinations of items listed below.

| Model Numbers and Description | | |
|-------------------------------|-----------------|-----------------------------------------------------------------------------------|
| | Model<br>Number | Product Description |
| Disposables | CC1.P1 | Combined Oxygen and Temperature Sensing Probe |
| | IP1 | Introducer Kit with Bolt, for use with CC1.P1<br>Oxygen/Temperature Probe |
| | IP2 | Introducer Kit, two way, for CC1.P1.<br>Oxygen/Temperature Probe and an ICP Probe |
| | VK5.2 | Introducer Kit, trocar/sleeve for tunneled placement of<br>the CC1.P1 |
| PMO<br>Interface<br>Device | PMO.BOX | Patient monitor interface |
| Monitor<br>Accessories | BC10.<br>PMO | Connects the CC1.P1 to the existing LICOX Monitor,<br>AC3 |

## Table 1 LICOX PMO Brain Oxygen Monitoring System dal Numbers and Description

## Statement of Intended Use:

The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to 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.

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| | LICOX<br>Brain Oxygen Monitoring<br>System<br>(K002765) | LICOX PMO Brain Oxygen<br>Monitoring System |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The LICOX Brain Oxygen Monitoring<br>System measures intracranial oxygen<br>and temperature and is intended as an<br>adjunct monitor of trends of these<br>parameters, indicating the perfusion<br>status of cerebral tissue local to sensor<br>placement. LICOX System values are<br>relative within an individual, and<br>should not be used as the sole basis for<br>decisions as to diagnosis or therapy. It<br>is intended to provide data additional<br>to that obtained by current clinical<br>practice in cases where hypoxia or<br>ischemia are a concern. | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Anatomical Site | Brain parenchyma | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Target<br>Population | Head trauma, craniotomy, with<br>possible hypoxia or ischemia. | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| | LICOX CMP Monitor | LICOX PMO Interface Device |
| Operation | Analog with Microprocessor | Analog only |
| Screen | Alpha-numeric | None |
| Monitoring | Continuous | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Power Supply | Custom A/C-D/C Supply | Powered by battery or excitation<br>voltage of patient bedside monitor |
| Data output | Serial and Analog | Analog only |
| Dimensions | 34 cm x 32 cm x 8.5 cm | 8 cm x 18cm x 4.5 cm |
| Weight | 4.2 kg | 2.7 kg |
| Case material | Plastic | Plastic |
| Operating<br>Temperature | +10°C to +40°C | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| | LICOX Sensor | LICOX PMO Sensor |
| Parameters | Brain PbtO2<br>Temperature | Brain PbtO2 |
| Sterility | Sterile | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Single-use | Yes | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| | LICOX<br>Brain Oxygen Monitoring<br>System<br>(K002765) | LICOX PMO Brain Oxygen<br>Monitoring System |
| Single-use | Yes | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Monitoring<br>duration | 5 days | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Tissue<br>contacting<br>material | Polyethylene | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| O2 Sensing<br>technology | Clark Cell | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| Outside<br>diameter | 0.8 mm | 0.65 to 1.3 mm |
| Patient Access | Introducer and Bolt Kit, tunneling<br>trocar and sheath | Introducer and bolt kit, tunneling<br>trocar and sheath |
| Calibration | Smart Card calibrated to each oxygen<br>sensor during manufacture, Smart<br>Card read by monitor at time of use | Calibration information stored within<br>the connector and calibrates<br>automatically when connected to the<br>PMO Interface Device. Or<br>Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System when used with the LICOX<br>CMP monitor. |
| In Vitro<br>Accuracy,<br>PbtO2 | $\pm$ 2.0mmHg (0-20 mm Hg)<br>$\pm$ 10% (21 mm Hg-50 mm Hg)<br>$\pm$ 13% > 51 mm Hg | Identical to the currently marketed<br>LICOX Brain Oxygen Monitoring<br>System. |
| | LICOX Temperature Sensor | LICO PMO Sensor |
| Temperature<br>Sensing<br>Technology | Type K thermocouple as part of the<br>C8.B temperature probe | Type K thermocouple incorporated<br>into the CC1.P1 probe |
| In Vitro<br>Accuracy,<br>Temperature | $\pm$ 0.2°C | N.A |

# Comparison of technological characteristics to the predicate device:

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## Safety

Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the LICOX oxygen / temperature sensing probe, probe introducer, bolt and tunneling sheath are safe for their intended use.

In addition, the LICOX PMO Brain Oxygen Monitoring System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use.

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The LICOX PMO Brain Oxygen Monitoring System manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

#### Conclusion:

Management of the neurological recovery of patients who suffer a traumatic brain injury or undergo brain surgery may be aided by the use of monitoring systems such as the LICOX PMO Brain Oxygen Monitoring System. When used in conjunction with the existing armamentarium, direct monitoring of the Partial Pressure of Oxygen in brain provides the clinician with an additional significant parameter that can be used to avoid secondary insult and improve recovery.

The LICOX PMO Brain Oxygen Monitoring System is substantially equivalent to the predicate devices delineated in the submission and the requirements for a Premarket Notification 510(k) as defined in 21 CFR, Part 807.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

Ms. Nancy A. Mathewson, Esq. Director, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K040235

Trade/Device Name: LICOX PMO Brain Oxygen Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: January 29, 2004 Received: February 2, 2004

Dear Ms. Mathewson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or 10 commerce prior to May 20, 1970, the enaordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter rest (rece) that as nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mance the act include requirements for annual registration, listing of general controll provision practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elasbition (voor accres) ols. Existing major regulations affecting your device can thay be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the councements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Ticase oc advised that I Dri instan that your device complies with other requirements of the Act that 11.71 has mates and regulations administered by other Federal agencies. You must of any I cacial statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) by became (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Nancy A. Mathewson, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manketing your and equivalence of your device to a legally premarket nothleation: "The PDA maing of cation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice ior your as [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain . Missuallung by telefoned to premaintentibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K040235

Device Name: LICOX PMO Brain Oxygen Monitoring System

Indications For Use: The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data for doctories as to obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K640235