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 Description

AI/ML Overview

The provided 510(k) Premarket Notification for the LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe primarily focuses on establishing substantial equivalence to a predicate device (LICOX® CC1.SB). Therefore, the study described is a comparison to the predicate device, rather than an independent performance study against specific acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate LICOX® CC1.SB)	Reported Device Performance (LICOX® CC1.G2)
In Vitro Accuracy, pO₂	±2.0mmHg (0-20 mm Hg) ±10% (21 mm Hg-50 mm Hg) ±12% > 51 mm Hg	Identical to the LICOX® CC1.SB

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical trial or algorithm validation. Instead, the performance of the LICOX® CC1.G2 was evaluated relative to the predicate device, LICOX® CC1.SB, through "extensive oxygen pressure measurement accuracy testing".

Sample Size: Not specified. The document states "Results of the testing showed that the catheter design met all accuracy specifications." This implies internal testing, likely on multiple units of the device.
Data Provenance: Not explicitly stated, but implicitly from in vitro testing conducted by the manufacturer, Integra NeuroSciences. The data is thus retrospective in terms of being generated during product development and testing, not from real-world patient data for this specific comparison.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the in vitro accuracy testing would be established by the reference standards used in the laboratory setting (e.g., gas mixtures with known oxygen concentrations, calibrated measurement equipment), not by human experts.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation was based on in vitro measurement against established accuracy specifications, not on human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No. This document describes a medical device, not an AI algorithm requiring human-in-the-loop performance evaluation. The comparison is between two physical devices and their technical specifications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

Not applicable. This is a physical medical device (catheter) that measures physiological parameters.

7. The Type of Ground Truth Used

The ground truth for the "oxygen pressure measurement accuracy testing" was established through reference standards in an in vitro laboratory setting. This would involve controlled environments where the actual pO2 can be precisely known and compared to the device's reading.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 (858) 455-1115

Date summary was prepared:

February 19, 2002

Name of the device:

Proprietary Name:	LICOX® Brain Oxygen Monitoring SystemLICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe
Common Name:	Brain oxygen monitoring device
Classification Name:	Intracranial Pressure Monitoring Device,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:

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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-microprobe is intended for use with the LICOXBrain Oxygen Monitoring System. The LICOXBrain Oxygen Monitoring System measuresintracranial oxygen and temperature and isintended as an adjunct monitor of trends of theseparameters, indicating the perfusion status ofcerebral tissue local to sensor placement. LICOXSystem values are relative within an individual,and should not be used as the sole basis fordecisions as to diagnosis or therapy. It isintended to provide data additional to thatobtained by current clinical practice in caseswhere hypoxia or ischemia are a concern.	Identical to theLICOX® CC1.SB
Anatomical Site	Brain parenchyma	Identical to theLICOX® CC1.SB
Target Population	Head trauma, craniotomy, with possiblehypoxia or ischemia.	Identical to theLICOX® CC1.SB
Parameters	Brain pO2	Identical to theLICOX® CC1.SB
Sterility	Sterile	Identical to theLICOX® CC1.SB
Single-use	Yes	Identical to theLICOX® CC1.SB
Monitoring duration	5 days	Identical to theLICOX® CC1.SB
Tissue contactingmaterial	Polyethylene	Identical to theLICOX® 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 Sensingtechnology	Clark Cell	Identical to theLICOX® CC1.SB
Calibration	Smart Card calibrated to each oxygen sensorduring manufacture, Smart Card read by monitorat time of use	Identical to theLICOX® CC1.SB
In Vitro Accuracy, pO₂	±2.0mmHg (0-20 mm Hg)±10% (21 mm Hg-50 mm Hg)±12% > 51 mm Hg	Identical to theLICOX® CC1.SB
System monitor	LICOX CMP Monitor and associatedaccessories and cables	Identical to theLICOX® CC1.SB
Packaging Method andMaterials	Double blister tray (PETG with Tyvek lid) placedin a chevron pouch made of Flexovac(polyester/polyethylene) foil with uncoated paper.	Identical to theLICOX® CC1.SB
Sterilization Process	Gamma Radiation to a sterilityassurance level of 10⁻⁶.	Identical to theLICOX® 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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

Regulation Number and Section

§ 882.1620 Intracranial pressure monitoring device.

(a)
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.(b)
Classification. Class II (performance standards).