(127 days)
The Integra Licox PtO₂ monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a 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.
The Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor.
The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the trend data stored on the monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.
The provided text describes the Integra® Licox® PtO2 Monitor, an intracranial pressure monitoring device. It outlines the device's intended use, technological characteristics, and non-clinical testing performed to establish its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions "pre-defined performance and safety specifications" and that testing confirmed "all Design Inputs (requirements and specifications) have been met." However, it does not provide a specific table of acceptance criteria with numerical targets or thresholds for performance metrics like accuracy, alarm sensitivity, or trending precision. Instead, it lists the types of tests conducted:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| PtO2 Accuracy | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Temperature Accuracy | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Alarm Setting, Accuracy, Volume | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Trend Functionality | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Data Export Functionality (bedside monitor, external storage) | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Fault Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Electromagnetic Compatibility (EMC) | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Electrical Safety | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Environmental Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
| Cleaning Testing | "The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports... Testing was performed to ensure that the device met pre-defined performance and safety specifications." |
Important Note: The document explicitly states that "All necessary testing has been completed... and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met." However, it does not provide the specific numerical acceptance criteria or the quantitative results of these tests.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "production equivalent units" were used for testing. However, it does not specify the sample size for the test set.
Regarding data provenance, the document describes non-clinical testing performed on the device itself (e.g., accuracy, alarms, functionality). This is not data derived from patient studies or human subjects. Therefore, information about country of origin of data or retrospective/prospective nature is not applicable here as it relates to device performance testing, not clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to the type of testing described in the document. The device performance tests (accuracy, alarms, etc.) typically rely on calibrated instruments and established engineering standards to determine "ground truth," not expert human adjudication of diagnostic outcomes.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical device performance testing described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar tasks requiring human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone monitor, meaning it directly measures and displays PtO2 and temperature values. The testing described (PtO2 Accuracy, Temperature Accuracy, Alarm setting, etc.) assesses the performance of this standalone device/algorithm without human-in-the-loop performance. However, this is distinct from AI-driven algorithms where "standalone" usually implies the algorithm makes a decision independently. In this context, the device is the "algorithm" for measurement and display.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests like PtO2 Accuracy and Temperature Accuracy, the ground truth would have been established using calibrated reference standards or laboratory measurements that are known to be highly accurate. For other functional tests (alarms, trending, data export), the ground truth is defined by the device's functional specifications and expected behavior.
8. The Sample Size for the Training Set
This information is not applicable as the Integra® Licox® PtO2 Monitor is a measurement device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device does not use a training set in the context of machine learning.
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510(k) Summary
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 22 Terry AvenueBurlington, MA 01830 |
| Phone Number | (781) 565-1347 |
| Fax Number | (781) 238-0645 |
| Establishment Registration Number | 1222895 |
| Name of Contact Person | Elizabeth McMeniman |
| Date Prepared | April 26, 2013 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | Integra® Licox® PtO2 Monitor |
| Common or Usual Name | Intracranial pressure monitor |
| Classification Name | Intracranial pressure monitoring device |
| Classification Panel | Neurology |
| Regulation | Class II, under 21 CFR 882.1620 |
| Product Code(s) | GWM |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed |
LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems - K002765 .
- LICOX PMO BRAIN MONITORING SYSTEM- K040235 .
- INTEGRA CAMINO ICP MONITOR- K121573 .
- . INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER- K121159
807.92(a)(4) - Device description
The Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor.
The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the trend data stored on the monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.
| 807.92(a)(5) – Intended Use of the device | |
|---|---|
| Indications for Use | The Integra Licox PtO₂ monitor measures oxygen partial pressure(PtO2) and temperature in brain tissue and these parameters are usedtogether as an aid in the determination of the perfusion status ofcerebral tissue local to sensor placement. Monitor values arerelative within an individual, and should not be used as the sole basisfor determining a diagnosis or therapy. It is intended to providedata additional to that obtained by current clinical practice in caseswhere hypoxia or ischemia are a concern. |
| AUG 3 0 2013 |
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| Intended Users | The operation of the Licox PtO₂ monitor is to be performed by designated qualified hospital staff (i.e. neurosurgeon, nurse, intensivist, trauma physician, physician's assistant, or other appropriately trained staff). |
|---|---|
| ---------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
807.92(a)(6) Summary of the technological characteristics of the device compa predicate
The design of both the modified device and the predicate device are similar. Both of the devices receive signals from the probes that are then translated into the oxygen partial pressure & temperature readings. These readings are then displayed on the screen for the health care practitioners to use as additional information in treatment of the patient.
Integra Licox PrO2 monitor and the predicate device have intended uses, environment for use, device classifications, product codes and measureable parameters as outlined in the substantial equivalence chart and discussion. Any differences in the technological characteristics of the new device do not raise different questions of safety and effectiveness than the predicate device. .
| Product Characteristics | Comparison Integra® Licox® PtO₂ Monitor to the predicate | |
|---|---|---|
| LICOX Brain Oxygen Monitoring System, CMP® Monitor | ||
| Parameter Display | ||
| PtO2 Trend (5 day) Display | The predicate Licox CMP Monitoring System does not trendPtO2 data. | |
| Trend Data Storage | The predicate Licox CMP Monitoring System does not trend orstore PtO2 data. | |
| Trend Data Retention | The predicate Licox CMP Monitoring System does not retaindata specific to the probe. | |
| Data Output | The predicate Licox CMP Monitoring System does not includea USB port. | |
| System PtO₂ PerformanceRequirements | Same | |
| Alarms | The predicate Licox CMP Monitoring System does not have aLow PtO2 Alarm or a Low Battery Alarm | |
| Parameter Indicators | Same | |
| User Inputs via GUI screen | The predicate Licox CMP Monitor used a key pad. | |
| Portability and Handling | The predicate Licox CMP Monitor cannot be mounted to a pole.The proposed Licox PtO2 monitor can be mounted to a polewith diameter between 0.5 and 1.2 inches outer diameter. | |
| Bedside Output | Same | |
| 807.92(b)(1-2) - Nonclinical Tests Submitted |
The Integra Licox PtO2 monitor was tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units.
Testing was performed to ensure that the device met pre-defined performance and safety specifications and to ensure that hazard mitigations functioned as designed.
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Testing includes, but is not limited to the following:
- . PtO2 Accuracy
- Temperature Accuracy .
- Alarm setting, accuracy, volume etc. .
- Trend functionality
- Data Export Functionality (bedside monitor, external storage) .
- Fault testing .
- Electromagnetic Compatibility .
- Electrical Safety .
- Environmental Testing .
- Cleaning Testing .
807.92(b)(3) – Conclusions drawn from non-clinical data
All necessary testing has been completed for the Integra Licox PtO2 monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed that the Integra Licox PtO2 monitor is safe and effective under the proposed conditions of use and is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
Integra LifeSciences Corporation % Ms. Elizabeth McMeniman Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, NJ 08536
Re: K131184
Trade/Device Name: Integra® Licox® PtO2 Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: July 26, 2013 Received: July 29, 2013
Dear Ms. McMeniman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Elizabeth McMeniman
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default,htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131184
Device Name: Integra® Licox® PtO2 Monitor
Indications For Use:
The Integra Licox PtO2 Monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K131184
Page 1 of 1
§ 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).