(104 days)
Not Found
No
The summary describes a device for monitoring and displaying physiological data (ICP and temperature) and does not mention any AI/ML capabilities for analysis, interpretation, or prediction.
No
The device is for monitoring intracranial pressure and temperature, not for treating a disease or condition.
Yes
The device is described as measuring and monitoring intracranial pressure and temperature, providing numerical and waveform data, which are used by qualified neurosurgeons or neurointensivists to assess and manage patient conditions.
No
The device description explicitly states it is a "compact, portable device" and mentions connecting to "catheters," indicating it includes hardware components beyond just software.
Based on the provided information, the Integra Camino ICP Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is indicated for the measurement of intracranial pressure and temperature directly in the brain. This is a direct physiological measurement within the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a device that connects to catheters inserted into the brain to continuously monitor pressure and temperature. This is consistent with an in vivo monitoring device, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Integra Camino ICP Monitor is an in vivo monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters.
The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified neurosurgeons or neurointensivists
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)
Nonclinical Tests Submitted: The Integra Camino ICP Monitor tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market. Testing was performed to ensure that the device met requirements specifications and to ensure that hazard mitigations functioned as intended. Testing includes but is not limited to the following: ICP 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.
Conclusions drawn from non-clinical data: All necessary testing has been completed for the Integra Camino ICP Monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed The Integra Camino ICP Monitor is safe and effective under the proposed conditions of use and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
K12 1573
SEP 1 0 2012
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro NJ 08536 | |
| Phone Number | (609) 936-3634 |
| Fax Number | (609) 275-9445 |
| Establishment | |
| Registration Number | 3003418325 |
| Name of Contact Person | Erin Doyle |
| Date Prepared | May 25, 2012 |
| 807.92(a)(2) - Name of device | |
| Trade or Propriety Name | Integra™ Camino® ICP 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 | |
| Camino® Multi Parameter Monitor - K962928 |
510(k) Summary
807.92(a)(4) - Device description
The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters.
The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP 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 Camino ICP Monitor is indicated for use by
qualified neurosurgeons or neurointensivists for
measurement of intracranial pressure and temperature. |
| --------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The design of both the modified device and the predicate device is similar. Both of the devices receive signals from the catheters that are then translated into the intracranial pressure & temperature reading. These readings are then displayed on the screen for the health care practitioners to use as additional information in treatment of the patient.
1
Integra™ Camino® ICP Monitor and the predicate device have similar intended uses, indications for use, technology, environment for use, device classifications, product codes and measureable parameters as outlined in the substantial equivalence chart and discussion. There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.
| Product
Characteristics | Comparison Integra™ Camino® ICP Monitor to the
predicate Camino® Multi Parameter Monitor |
|------------------------------------|------------------------------------------------------------------------------------------------|
| Parameter Display | Similar |
| Data Output | Similar |
| Bedside Output | Similar |
| System Performance
Requirements | Similar |
| Alarms | Similar |
| Parameter Indicators | Similar |
| User Inputs | Integra™ Camino® ICP Monitor - Touch screen Camino® Multi Parameter Monitor - Membrane Buttons |
| Portability and
Handling | Similar |
807.92(b)(1-2) - Nonclinical Tests Submitted
The Integra Camino ICP Monitor tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market. Testing was performed to ensure that the device met requirements specifications and to ensure that hazard mitigations functioned as intended.
Testing includes but is not limited to the following:
- . ICP 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 Camino ICP Monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met. Testing confirmed The Integra Camino ICP Monitor is safe and effective under the proposed conditions of use and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 10 2012
Integra LifeSciences Corporation % Mr. Erin Doyle Regulatory Affairs Associate 311 Enterprise Drive Plainsboro, NJ 08536
Re: K121573
Trade Name: Integra™ Camino® ICP Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: August 2, 2012 Received: August 3, 2012
Dear Mr. Doyle:
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 r lease of acreased 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 or any I vith 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
3
Page 2 - Mr. Erin Doyle
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Evdelman, M.D. Director
Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 12157-3
Indications for Use
510(k) Number (if known): K121573
.
Device Name:
Integra™ Camino® ICP Monitor
Indications For Use:
The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (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)
AC
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K121573 510(k) Number
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