(29 days)
Not Found
No
The summary describes a sensor and monitoring system for measuring physiological parameters (oxygen and temperature) and does not mention any computational analysis or interpretation of data using AI/ML.
No
The device is a brain oxygen catheter-microprobe that measures intracranial oxygen and temperature, providing diagnostic information rather than directly treating a condition.
Yes
The device is described as measuring intracranial oxygen and temperature, and its values are intended to indicate the "perfusion status of cerebral tissue local to sensor placement." This information is used as an "adjunct monitor of trends" to provide data "additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern," which directly supports diagnostic understanding of a patient's condition.
No
The device description explicitly states it is a "brain oxygen catheter-microprobe" and is used in conjunction with a "LICOX® CMP Monitor and it's associated accessories and cables," indicating it is a hardware device with associated components, not software only.
Based on the provided information, the LICOX® CC1.G2 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device measures intracranial oxygen and temperature in vivo (within the brain parenchyma). IVDs are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body).
- Device Description: The description reinforces that the probe is used in conjunction with a monitor to measure parameters within the body.
- Anatomical Site: The specified anatomical site is the "Brain parenchyma," which is an internal part of the body.
Therefore, the LICOX® CC1.G2 is an in vivo monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain parenchyma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
In Vitro Accuracy, pO₂:
±2.0mmHg (0-20 mm Hg)
±10% (21 mm Hg-50 mm Hg)
±12% > 51 mm Hg
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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510(k) Premarket Notification LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Integra NeuroSciences
020558
1/3
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 System
LICOX® 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:
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.
1
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 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. | Identical to the | |
| LICOX® CC1.SB | ||
| Anatomical Site | Brain parenchyma | Identical to the |
| LICOX® CC1.SB | ||
| Target Population | Head trauma, craniotomy, with possible | |
| hypoxia or ischemia. | Identical to the | |
| LICOX® CC1.SB | ||
| Parameters | Brain pO2 | Identical to the |
| LICOX® CC1.SB | ||
| Sterility | Sterile | Identical to the |
| LICOX® CC1.SB | ||
| Single-use | Yes | Identical to the |
| LICOX® CC1.SB | ||
| Monitoring duration | 5 days | Identical to the |
| LICOX® CC1.SB | ||
| Tissue contacting | ||
| material | Polyethylene | Identical to the |
| LICOX® CC1.SB |
2
510(k) Premarket Notification LICOX® CC1.G2 Brain Oxygen Catheter-MicroProbe Integra NeuroSciences
| Parameter | LICOX® CC1.SB | LICOX® CC1.G2 |
|---|---|---|
| O₂ Sensing | ||
| technology | Clark Cell | Identical to the |
| LICOX® CC1.SB | ||
| Calibration | Smart Card calibrated to each oxygen sensor | |
| during manufacture, Smart Card read by monitor | ||
| at time of use | Identical to the | |
| LICOX® 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 the | |
| LICOX® CC1.SB | ||
| System monitor | LICOX CMP Monitor and associated | |
| accessories and cables | Identical to the | |
| LICOX® CC1.SB | ||
| Packaging Method and | ||
| Materials | Double blister tray (PETG with Tyvek lid) placed | |
| in a chevron pouch made of Flexovac | ||
| (polyester/polyethylene) foil with uncoated paper. | Identical to the | |
| LICOX® CC1.SB | ||
| Sterilization Process | Gamma Radiation to a sterility | |
| assurance level of 10⁻⁶. | Identical to the | |
| 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.
3
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.
4
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
5
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