(78 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts. The device description focuses on hardware components and basic physiological parameter monitoring.
No
The device measures parameters but does not actively treat or modify the body; it is an adjunct monitor.
No
The device is intended as an "adjunct monitor of trends" and explicitly states that its values "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it provides supportive data rather than a definitive diagnosis.
No
The device description explicitly states that the system consists of a combined oxygen and temperature probe, an interface device, and cranial access accessories, indicating hardware components are included.
Based on the provided information, the LICOX PMO Brain Oxygen Monitoring System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The LICOX system measures parameters directly within the brain tissue (intracranial oxygen and temperature) using a probe inserted into the patient. It does not analyze samples like blood, urine, or tissue biopsies in a laboratory setting.
- The intended use describes direct monitoring of physiological parameters within the body. The system is described as an "adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement." This is a description of an in vivo (within the living body) measurement, not an in vitro (in glass, or outside the living body) test.
Therefore, the LICOX PMO Brain Oxygen Monitoring System falls under the category of a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / 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 additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
Product codes
GWM
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 include minor accessories such as cables or convenience kits that are combinations of items listed below.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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 (858) 455-1115 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
1
include minor accessories such as cables or convenience kits that are combinations of items listed below.
| Model Numbers and Description | ||
|---|---|---|
| Model | ||
| Number | Product Description | |
| Disposables | CC1.P1 | Combined Oxygen and Temperature Sensing Probe |
| IP1 | Introducer Kit with Bolt, for use with CC1.P1 | |
| Oxygen/Temperature Probe | ||
| IP2 | Introducer Kit, two way, for CC1.P1. | |
| Oxygen/Temperature Probe and an ICP Probe | ||
| VK5.2 | Introducer Kit, trocar/sleeve for tunneled placement of | |
| the CC1.P1 | ||
| PMO | ||
| Interface | ||
| Device | PMO.BOX | Patient monitor interface |
| Monitor | ||
| Accessories | BC10. | |
| PMO | Connects the CC1.P1 to the existing LICOX Monitor, | |
| 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.
2
| | LICOX
Brain Oxygen Monitoring
System
(K002765) | LICOX PMO Brain Oxygen
Monitoring System |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 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 currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Anatomical Site | Brain parenchyma | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Target
Population | Head trauma, craniotomy, with
possible hypoxia or ischemia. | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
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
LICOX Brain Oxygen Monitoring
System. |
| Power Supply | Custom A/C-D/C Supply | Powered by battery or excitation
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
Temperature | +10°C to +40°C | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| | LICOX Sensor | LICOX PMO Sensor |
| Parameters | Brain PbtO2
Temperature | Brain PbtO2 |
| Sterility | Sterile | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Single-use | Yes | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| | LICOX
Brain Oxygen Monitoring
System
(K002765) | LICOX PMO Brain Oxygen
Monitoring System |
| Single-use | Yes | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Monitoring
duration | 5 days | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Tissue
contacting
material | Polyethylene | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| O2 Sensing
technology | Clark Cell | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| Outside
diameter | 0.8 mm | 0.65 to 1.3 mm |
| Patient Access | Introducer and Bolt Kit, tunneling
trocar and sheath | Introducer and bolt kit, tunneling
trocar and sheath |
| Calibration | Smart Card calibrated to each oxygen
sensor during manufacture, Smart
Card read by monitor at time of use | Calibration information stored within
the connector and calibrates
automatically when connected to the
PMO Interface Device. Or
Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System when used with the LICOX
CMP monitor. |
| In Vitro
Accuracy,
PbtO2 | $\pm$ 2.0mmHg (0-20 mm Hg)
$\pm$ 10% (21 mm Hg-50 mm Hg)
$\pm$ 13% > 51 mm Hg | Identical to the currently marketed
LICOX Brain Oxygen Monitoring
System. |
| | LICOX Temperature Sensor | LICO PMO Sensor |
| Temperature
Sensing
Technology | Type K thermocouple as part of the
C8.B temperature probe | Type K thermocouple incorporated
into the CC1.P1 probe |
| In Vitro
Accuracy,
Temperature | $\pm$ 0.2°C | N.A |
Comparison of technological characteristics to the predicate device:
3
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.
4
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.
5
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.
6
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
7
Indications for Use
510(k) Number (if known):
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
Page 1 of 1
510(k) Number K640235