LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE

K020558 · Integra Neurosciences · GWM · Mar 21, 2002 · Neurology

Device Facts

• Record ID: K020558
• Device Name: LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
• Applicant: Integra Neurosciences
• Product Code: GWM · Neurology
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX 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 CC1.G2 is a brain oxygen catheter-microprobe used with the LICOX Brain Oxygen Monitoring System; measures intracranial oxygen (pO2) and temperature. Input: electrochemical signals from Clark-type oxygen sensor placed in brain parenchyma. Transformation: sensor signals processed by LICOX CMP Monitor; calibration via Smart Card. Output: real-time pO2 and temperature trends. Used in clinical settings (e.g., ICU/OR) by physicians to monitor cerebral perfusion status. Data serves as adjunct to clinical practice; assists in identifying hypoxia or ischemia. Benefits: provides localized tissue oxygenation trends to support clinical decision-making; not for use as sole diagnostic or therapeutic basis.

Clinical Evidence

No clinical data provided. Evidence consists of biocompatibility testing per ISO 10993/FDA G95-1 and bench testing confirming oxygen pressure measurement accuracy meets specifications.

Technological Characteristics

Polyethylene catheter-microprobe; Clark Cell oxygen sensing technology; gamma radiation sterilization (SAL 10^-6); single-use; 5-day monitoring duration. Calibration via Smart Card. System includes LICOX CMP Monitor, cables, and accessories. Packaging: PETG/Tyvek blister tray in Flexovac foil pouch.

Indications for Use

Indicated for patients with head trauma or undergoing craniotomy where monitoring of cerebral tissue oxygenation and temperature is required due to potential hypoxia or ischemia.

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® CC1.SB Brain Oxygen Catheter-Microprobe (K002765)

Submission Summary (Full Text)

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510(k) Premarket Notification LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Integra NeuroSciences

020558

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# LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe

# MAR 2 1 2002

#### 510(k) SUMMARY

### Submitter's name and address:

Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536

## Contact person and telephone number:

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

#### Date summary was prepared:

February 19, 2002

#### Name of the device:

| Proprietary Name: | LICOX® Brain Oxygen Monitoring System<br>LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe |
|-----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Brain oxygen monitoring device |
| Classification Name: | Intracranial Pressure Monitoring Device,<br>21 CFR 882.1620, 84GWM |
| Classification Panel: | Neurology Device Panel |

### Substantial Equivalence:

The LICOX® CC1.G2 product was designed to have the same indications for use and perform to the same specifications as the LICOX® CC1.SB Brain Oxygen Catheter-Microprobe (510(k) K002765).

#### Device Description:

The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature. The probe is used in conjunction with the LICOX® CMP Monitor and it's associated accessories and cables.

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K020558 2/3

## Statement of Intended Use:

The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct Dystem moubares marameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and local to believe pracement 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.

# Comparison of technological characteristics to the predicate device:

| Parameter | LICOX® CC1.SB | LICOX® CC1.G2 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Indications for Use | The LICOX® CC1.G2 is a brain oxygen catheter-<br>microprobe is intended for use with the LICOX<br>Brain Oxygen Monitoring System. The LICOX<br>Brain Oxygen Monitoring System measures<br>intracranial oxygen and temperature and is<br>intended as an adjunct monitor of trends of these<br>parameters, indicating the perfusion status of<br>cerebral tissue local to sensor placement. LICOX<br>System values are relative within an individual,<br>and should not be used as the sole basis for<br>decisions as to diagnosis or therapy. It is<br>intended to provide data additional to that<br>obtained by current clinical practice in cases<br>where hypoxia or ischemia are a concern. | Identical to the<br>LICOX® CC1.SB |
| Anatomical Site | Brain parenchyma | Identical to the<br>LICOX® CC1.SB |
| Target Population | Head trauma, craniotomy, with possible<br>hypoxia or ischemia. | Identical to the<br>LICOX® CC1.SB |
| Parameters | Brain pO2 | Identical to the<br>LICOX® CC1.SB |
| Sterility | Sterile | Identical to the<br>LICOX® CC1.SB |
| Single-use | Yes | Identical to the<br>LICOX® CC1.SB |
| Monitoring duration | 5 days | Identical to the<br>LICOX® CC1.SB |
| Tissue contacting<br>material | Polyethylene | Identical to the<br>LICOX® CC1.SB |

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### 510(k) Premarket Notification LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Integra NeuroSciences

K020558

| Parameter | LICOX® CC1.SB | LICOX® CC1.G2 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| O₂ Sensing<br>technology | Clark Cell | Identical to the<br>LICOX® CC1.SB |
| Calibration | Smart Card calibrated to each oxygen sensor<br>during manufacture, Smart Card read by monitor<br>at time of use | Identical to the<br>LICOX® CC1.SB |
| In Vitro Accuracy, pO₂ | ±2.0mmHg (0-20 mm Hg)<br>±10% (21 mm Hg-50 mm Hg)<br>±12% > 51 mm Hg | Identical to the<br>LICOX® CC1.SB |
| System monitor | LICOX CMP Monitor and associated<br>accessories and cables | Identical to the<br>LICOX® CC1.SB |
| Packaging Method and<br>Materials | Double blister tray (PETG with Tyvek lid) placed<br>in a chevron pouch made of Flexovac<br>(polyester/polyethylene) foil with uncoated paper. | Identical to the<br>LICOX® CC1.SB |
| Sterilization Process | Gamma Radiation to a sterility<br>assurance level of 10⁻⁶. | Identical to the<br>LICOX® CC1.SB |

### Safety:

Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the LICOX® CC1.G2 catheter are safe for its intended use.

In addition, the LICOX® CC1.G2 catheter was subjected to extensive oxygen pressure measurement accuracy testing.. Results of the testing showed that the catheter design met all accuracy specifications.

The LICOX® CC1.G2 manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

#### Conclusion:

The LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe is substantially equivalent to the unmodified LICOX® CC1.SB Brain Oxygen Catheter-MicroProbe. The modifications do not affect the intended use or the fundamental scientific technology of the device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 1 2002

Ms. Nancy A. Mathewson Director, Regulatory Affairs Integra NeuroSciences 5955 Pacific Center Boulevard San Diego, CA 92121-4309

Re: K020558

K020536
Trade/Device Name: LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: February 19, 2002 Received: February 20, 2002

Dear Ms. Mathewson:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We nave reviewed your Section 910(x) premise is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for use stated in the encrosule) to regars nement date of the Medical Device American so to commence provision to May 20, 1976, the enature with the provisions of the Federal Food, Drug, devices that have been recassinou in asses approval of a premarket approval application (PMA). alle Cosmetic Act (Act) that ao not request to the general controls provisions of the Act. The I ou may, merciole, market the dollow, of the Act include registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (500 above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of thay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I D71 3 issuates of a succession in other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I ederal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the For 8 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in 1 607), adoling (21 OFR Part 820); and if applicable, the electronic forth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Nancy A. Mathewson

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter will and on your finding of substantial equivalence of your device to a legally promaticated predicated." ce results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, 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,

Miriam C. Provost

For 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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### 510(k) Premarket Notification LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Integra NeuroSciences

### APPENDIX B

## Indications for Use Statement

510(k) Number

020558

Device Name LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe

# Indications

for Use

The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX 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.

# Miriam C. Provost

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

510(k) Number K020558

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109) OR

Over-The-Counter Use