(104 days)
The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
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.
The Integra™ Camino® ICP Monitor is a device designed to continuously determine and monitor intracranial pressure (ICP) and intracranial temperature (ICT)
directly in the brain.
- Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| ICP Accuracy | Met requirements | Testing confirmed accuracy |
| Temperature Accuracy | Met requirements | Testing confirmed accuracy |
| Alarm Setting, Accuracy, Volume | Met requirements | Functioned as intended |
| Trend Functionality | Met requirements | Functioned as intended |
| Data Export Functionality | Met requirements | Functioned as intended |
| Fault Testing | Met requirements | Functioned as intended |
| Electromagnetic Compatibility | Met requirements | Device is compatible |
| Electrical Safety | Met requirements | Device is safe |
| Environmental Testing | Met requirements | Passed environmental tests |
| Cleaning Testing | Met requirements | Passed cleaning tests |
| Overall Safety and Effectiveness | Safe and Effective | Confirmed safe and effective under proposed conditions of use |
Note: The provided document states that "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." Specific numerical acceptance criteria were not detailed in the provided text, so the table reflects the implied success of meeting undefined requirements.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document mentions "production equivalent units," but the number of units used for testing is not disclosed.
- Data Provenance: The study was conducted by Integra LifeSciences Corporation as part of their 510(k) submission. The context strongly suggests this was a prospective series of tests conducted on the device itself, rather than analyzing existing patient data. There is no mention of country of origin for specific data, as the tests were directly on the device's functional characteristics.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This document describes non-clinical performance testing of a medical device, not a study evaluating diagnostic accuracy based on expert interpretation. Therefore, there is no mention of "experts" being used to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). The ground truth for functional tests (like accuracy) would be established by validated test equipment and calibration standards.
-
Adjudication Method for the Test Set:
- Not applicable. The described testing is non-clinical performance testing of a device's functions against design inputs, not an evaluation of subjective outputs requiring expert adjudication.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This submission focuses on the technical performance and substantial equivalence of the device, not on comparing human reader performance with and without AI assistance. The device in question is an ICP monitor, not an AI-powered diagnostic tool.
-
If a Standalone Performance Study Was Done:
- Yes, a standalone performance study was done in the sense that the Integra™ Camino® ICP Monitor was tested by itself to ensure it met its performance specifications. The tests listed (ICP Accuracy, Temperature Accuracy, Alarm settings, Trend functionality, Data Export, etc.) were direct evaluations of the device's own capabilities, without human interaction being an integral part of measuring its primary performance metrics (e.g., accuracy of ICP/ICT readings).
-
The Type of Ground Truth Used:
- For tests like "ICP Accuracy" and "Temperature Accuracy," the ground truth would have been established using calibrated reference standards and measurement equipment. For other functional tests (e.g., "Alarm setting," "Data Export"), the ground truth would be predetermined specifications or expected behaviors as defined in the device's design inputs.
-
The Sample Size for the Training Set:
- Not applicable. This is a non-clinical device performance study, not a machine learning model development. Therefore, there is no concept of a "training set" in the context of this submission.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no training set.
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K12 1573
SEP 1 0 2012
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise DrivePlainsboro NJ 08536 |
| Phone Number | (609) 936-3634 |
| Fax Number | (609) 275-9445 |
| EstablishmentRegistration 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 byqualified neurosurgeons or neurointensivists formeasurement 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.
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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.
| ProductCharacteristics | Comparison Integra™ Camino® ICP Monitor to thepredicate Camino® Multi Parameter Monitor |
|---|---|
| Parameter Display | Similar |
| Data Output | Similar |
| Bedside Output | Similar |
| System PerformanceRequirements | Similar |
| Alarms | Similar |
| Parameter Indicators | Similar |
| User Inputs | Integra™ Camino® ICP Monitor - Touch screen Camino® Multi Parameter Monitor - Membrane Buttons |
| Portability andHandling | 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.
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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
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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
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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
Page _ of 1 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).