(268 days)
Not Found
No
The document describes a system based on microdialysis and chemical analysis, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The indications for use clearly state that the CMA System is intended as an "adjunct monitor of trends" and that its values "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it's a diagnostic/monitoring device, not one that provides therapy.
No
The device is intended as an "adjunct monitor of trends" and explicitly states that values "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it provides additional data for assessment rather than a definitive diagnosis. Its purpose is to show "local changes in the hypoxic/ischemic state of the brain tissue," which is a monitoring function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (catheters, pump, analyser, etc.) in addition to software.
Based on the provided information, the CMA Cerebral Tissue Monitoring System is an In Vitro Diagnostic (IVD) device.
Here's why:
- It analyzes samples derived from the human body: The system collects "dialysate" which is the Perfusion Fluid that has equilibrated with the interstitial fluid of the cerebral tissue. This dialysate contains biochemical markers (glucose, lactate, pyruvate) from the patient's body.
- It performs analysis on these samples: The CMA 600 Microdialysis Analyser analyzes the concentrations of glucose, lactate, and pyruvate in the collected dialysate.
- The analysis is used for medical purposes: The intended use states that the system is an "adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement." This information is used to provide "additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern." While it's not the sole basis for diagnosis or therapy, it provides data relevant to a medical condition.
The process of collecting a sample (dialysate) and then analyzing it outside the body to gain information about a patient's health status is the core function of an IVD. The fact that the analysis is performed by the CMA 600 Analyser on the collected dialysate further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
Product codes
GWM
Device Description
The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components:
- CMA 70 Brain Microdialysis Catheters.
- CMA 106 Pump and Syringe.
- Perfusion Fluid CNS.
- Microvials and Microvial Racks.
- CMA 600 Microdialysis Analyser and software.
- Reagents (lactate, pyruvate, glucose).
- Control Samples.
- Rinsing Fluid.
- Calibrator A.
The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semipermeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the CMA 600 Microdialysis Analyser. The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the CMA 600 showing the local changes in the hypoxic/ischemic state of the brain tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral tissue / brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital staff
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
20285
510(k) Summary for CMA Cerebral Tissue Monitoring System
1. SPONSOR
CMA/Microdialysis AB Box 2, SE-171 18 Solna Sweden
Robert Pelletier, General Manager, US Operations Contact Person: 978-251-1940, ext. 23 Telephone:
Date Prepared: October 21, 2002
2. DEVICE NAME
| Proprietary Name: | CMA Cerebral Tissue Monitoring System |
|---|---|
| Common/Usual Name: | Brain Ischemia/Hypoxia Monitoring System |
| Classification Name: | Intracranial Pressure Monitoring Device |
3. PREDICATE DEVICE
- K002765, LICOX Brain Oxygen Monitoring system, CMP® Monitor and IMC® . Systems
- K980380, CODMAN Neurotrend Multiparameter Sensor .
INTENDED USE 4.
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
1
5. DEVICE DESCRIPTION
The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components:
- CMA 70 Brain Microdialysis Catheters .
- CMA 106 Pump and Syringe .
- Perfusion Fluid CNS .
- Microvials and Microvial Racks .
- CMA 600 Microdialysis Analyser and software .
- Reagents (lactate, pyruvate, glucose) .
- Control Samples .
- Rinsing Fluid .
- . Calibrator A
The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semipermeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the CMA 600 Microdialysis Analyser. The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the CMA 600 showing the local changes in the hypoxic/ischemic state of the brain tissue.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The CMA Cerebral Tissue Monitoring System is substantially equivalent to the LICOX Brain Oxygen Monitoring system, CMP® Monitor and IMC® Systems, manufactured by Integra NeuroSciences and cleared for marketing under K002765, and the CODMAN Neurotrend Multiparameter Sensor, manufactured by Diametrics, Inc. and cleared for marketing under K980380.
The CMA, LICOX and CODMAN Systems are all intended to monitor trends in intracranial parameters to provide adjunctive diagnostic information for patients in whom hypoxia or ischemia are a concern. The CMA system assesses biochemical
2
markers of ischemia while the predicate devices measure p02, pCO2, pH and tissue However, numerous clinical studies have been conducted to temperature. demonstrate the correlations between these measures and their safety and effectiveness in a multimodal approach to monitoring brain injured patients.
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 consists of a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
9200 Corporate Boulevard Rockville MD 20850
CMA Microdialysis AB c/o Ms. Sheila Hemeon-Heyer Medical Device Consultants Inc. 49 Plain Street North Attleboro, MA 02760
Re: K020285
Trade/Device Name: CMA Cerebral Tissue Monitoring System Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: July 24, 2002 Received: July 25, 2002
Dear Ms. Hemeon-Heyer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
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Page 2 – Ms. Hemeon-Heyer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Muriam 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
5
510(k) Number (if known): K020285
Device Name: CMA Cerebral Tissue Monitoring System
Indications for Use:
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Purvis
Division of General, Restorative and Neurological Devices
510(k) Number K020285
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use ------------
(Optional Format 1-2-96)