(527 days)
No
The summary describes a sensor that measures physiological parameters and compares its performance to a predicate device. There is no mention of AI, ML, or any computational analysis beyond basic statistical comparisons.
No
The device is a monitoring system that measures physiological parameters. It does not provide any therapy.
Yes
Explanation: The device measures various physiological parameters (intracranial oxygen, carbon dioxide, pH, and temperature) to indicate the perfusion and metabolic acidosis/alkalosis status of cerebral tissue. These measurements are used to provide data for clinical assessment and diagnosis, especially in cases where hypoxia/ischemia is a concern, even if it's not the "sole basis for decisions as to diagnosis."
No
The device description explicitly mentions a "Neurotrend Sensor (C7004S)" which is a physical component used for measurement. The performance studies also focus on the testing of these sensors. This indicates the device includes hardware, not just software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Measures parameters in biological samples: The intended use states it measures "Intracranial oxygen, carbon dioxide, pH and temperature" in "cerebral tissue local to sensor placement." While the sensor is placed in vivo, the measurement is of the chemical composition of the tissue/fluid, which falls under the definition of an in vitro diagnostic test.
- Provides information about physiological status: The intended use explicitly states it provides information "indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue." This is diagnostic information derived from the measured parameters.
- In vitro testing described: The performance studies section describes "in vitro" testing using tonometers and precision gas mixtures to evaluate the sensor's accuracy and performance. This further supports the IVD nature of the device, as its performance is validated through in vitro methods.
While the sensor is placed in vivo, the core function is the in vitro analysis of chemical parameters within the tissue. This aligns with the definition of an IVD device.
N/A
Intended Use / Indications for Use
"The CODMAN Neurotrend Cerebral Tissue Monitoring System measures Intracranial oxygen, carbon dioxide, pH and temperature, and is intended as an indicallarial oxygon, and in these parameters, indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue local to sensor placement. metabolic academand values are relative within an individual, the Neurotrend 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/ischaemia is a concem."
Product codes
84GWM
Device Description
The Neurotrend Sensor (C7004S) is a modified version of the Fluorescent Paratrend 7 sensor which has been cleared for the US Market (K953893). The measurement parameters for Neurotrend are essentially the same as the Fluorescent Paratrend 7. The sensor does not require a heparin treatment, as a consequence of the application - to monitor cerebral tissue and fluid gas parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, cerebral tissue
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
Sensors were tested in vitro to determine whether the absence of the heparin treatment affected the performance of the sensors. Sensors, both heparin treated (n=8) and untreated (n=7), were calibrated as detailed in the Instructions For Use (IFU).
The tonometers were maintained at 37°C and were pre-equilibrated with precision gas mixtures to precise barometric pressure which allowed the calculation of "actual" partial pressures. The Henderson-Hasselbalch equation was used to determine the "actual" pH values in the different tonometers.
The 90% step response times were calculated from the data collected when moving the sensors from one equilibrated tonometer to another. Sensors were then allowed to run for 72 hours and the bias at the end of this time was averaged over the period to give mean drift.
The data were analysed by calculating the bias (the mean of the differences between the measured Paratrend 7 value and that the actual value of the equilibrated solution) and the precision (sample standard deviation of the differences). The data were collected over the relevant range of gases.
The results from the sensors were then collated and used to determine the performance characteristics of both sub-sets of sensors versus the primary standard.
Summary of Performance Studies
The device under review was manufactured under standard process conditions and calibrated on the Senior Monitor.
Sensors were tested in vitro to determine whether the absence of the heparin treatment affected the performance of the sensors. Sensors, both heparin treated (n=8) and untreated (n=7), were calibrated as detailed in the Instructions For Use (IFU).
The tonometers were maintained at 37°C and were pre-equilibrated with precision gas mixtures to precise barometric pressure which allowed the calculation of "actual" partial pressures. The Henderson-Hasselbalch equation was used to determine the "actual" pH values in the different tonometers.
The 90% step response times were calculated from the data collected when moving the sensors from one equilibrated tonometer to another. Sensors were then allowed to run for 72 hours and the bias at the end of this time was averaged over the period to give mean drift.
The data were analysed by calculating the bias (the mean of the differences between the measured Paratrend 7 value and that the actual value of the equilibrated solution) and the precision (sample standard deviation of the differences). The data were collected over the relevant range of gases.
The results from the sensors were then collated and used to determine the performance characteristics of both sub-sets of sensors versus the primary standard.
The data satisfy product accuracy claims and show comparable results for heparin-treated and non-heparin treated sensors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953893, K962928, K914497, K896515
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
Section 11 : 510(k) Summary
This section satisfies the 510(k) summary as required by 21 CFR 807-92 (C).
1. Submitter
Miss Jan Walters Diametrics Medical Limited Short Street High Wycombe Bucks HP11 2QH UK Tel: +44 1494 471671 Fax: +44 1494 474890 Date of Summary : 30th January 1998
2. Device Name
Proprietary : Neurotrend Multiparameter Sensor, with Paratrend 7+ Multiparameter Senior & Satellite Monitor System
Common : Multiparameter Catheter
3. Device Classification
| Panel | : Neurology Devices Panel |
|---|---|
| Classification | : Class II |
| FDA CFR | : 21 CFR 882.1620 |
| Description | : Device, Intracranial Pressure Monitoring |
| Classification No. | : 84GWM |
4. Statement of Substantial Equivalence
Diametrics Medical Ltd claims substantial equivalence to products which have received FDA clearance by the Premarket Notification process.
1
న్న Device Description
The Neurotrend Sensor (C7004S) is a modified version of the Fluorescent Paratrend 7 sensor which has been cleared for the US Market (K953893). The measurement parameters for Neurotrend are essentially the same as the Fluorescent Paratrend 7. The sensor does not require a heparin treatment, as a consequence of the application - to monitor cerebral tissue and fluid gas parameters.
6. Technological Characteristics
Measurement Technology
| pO₂ : | fibre optic, fluorescence quenching |
|---|---|
| Temp : | thermocouple |
| pCO₂ : | fibre optic, photometric absorption |
| pH : | fibre optic photometric absorption |
Monitor Technology
Analogue/digital
7. Intended Use
The Neurotrend Multiparameter Sensor measures intracranial oxygen, carbon dioxide, pH, and temperature. The Sensor is used in conjunction with the Paratrend 7+ Multiparameter Senior and/or Satellite Monitor Systems.
8. Predicate Devices
.
| K953893 | Fluorescent Paratrend 7 Multiparameter Blood Gas Monitoring
Sensor |
|---------|-----------------------------------------------------------------------|
| K962928 | Neurocare Intracranial Pressure & Temperature Monitoring Kit |
| K914497 | Microsensor Intracranial Pressure Transducer |
| K896515 | Laserflo Blood Perfusion Monitor 8PM₂ |
588
2
9. Comparison of Accuracy to the Predicate Fluorescent Paratrend 7 Device
The device under review was manufactured under standard process conditions and calibrated on the Senior Monitor.
Sensors were tested in vitro to determine whether the absence of the heparin treatment affected the performance of the sensors. Sensors, both heparin treated (n=8) and untreated (n=7), were calibrated as detailed in the Instructions For Use (IFU).
The tonometers were maintained at 37°C and were pre-equilibrated with precision gas mixtures to precise barometric pressure which allowed the calculation of "actual" partial pressures. The Henderson-Hasselbalch equation was used to determine the "actual" pH values in the different tonometers.
The 90% step response times were calculated from the data collected when moving the sensors from one equilibrated tonometer to another. Sensors were then allowed to run for 72 hours and the bias at the end of this time was averaged over the period to give mean drift.
The data were analysed by calculating the bias (the mean of the differences between the measured Paratrend 7 value and that the actual value of the equilibrated solution) and the precision (sample standard deviation of the differences). The data were collected over the relevant range of gases.
The results from the sensors were then collated and used to determine the performance characteristics of both sub-sets of sensors versus the primary standard.
10. Conclusion
The data satisfy product accuracy claims and show comparable results for heparin-treated and non-heparin treated sensors.
The device under review is considered substantially equivalent.
589
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JUL 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jan Walters Diametrics Medical, Ltd. Short Street High Wycombe, Bucks UNITED KINGDOM HP11 2QH
Re: K980380
Neurotrend Multiparameter Sensor C7004S Dated: February 23, 1999 Received: February 25, 1999
Dear Ms. Walters:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OO) for Medical Devices: General regulation (21 CFR Part 820) and that, through veriodic (QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally parketed predicate device 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Philip J. Phillips
Philip J. Phillips
Deputy Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 1
510(k) Number : K980380
Page 1 of 1
Device Name: CODMAN Neurotrend™ Multiparameter Monitoring System
Indications For Use:
"The CODMAN Neurotrend Cerebral Tissue Monitoring System measures Intracranial oxygen, carbon dioxide, pH and temperature, and is intended as an indicallarial oxygon, and in these parameters, indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue local to sensor placement. metabolic academand values are relative within an individual, the Neurotrend 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/ischaemia is a concem."
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER RAGE IF NECESSARY) 7/14/99
Concurrence of CDRH, Office of Office of Device Evaluation (ODE)
ADE
Prescription Use
(Per 21 CFR §801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
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