(62 days)
Not Found
No
The description focuses on the biochemical analysis of microdialysis samples and trend display, with no mention of AI or ML algorithms for data interpretation or prediction.
No
Explanation: The device is intended as an adjunct monitor to measure biochemical markers of ischemia in the brain and provides data for assessment of perfusion status, not to directly treat or cure a disease.
Yes
The "Intended Use / Indications for Use" states that the 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," and that it is "intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern." This aligns with the definition of a diagnostic device, which gathers information to help determine the nature or cause of a condition, even if it's not the sole basis for diagnosis.
No
The device description explicitly lists multiple hardware components, including catheters, a pump, syringes, microvials, racks, and analyzers, 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:
- Measures biochemical markers: The system measures glucose, lactate, and pyruvate levels. These are biochemical substances.
- Analyzes samples outside the body: The description clearly states that the "dialysate is analyzed for the concentrations of glucose, lactate and pyruvate" using a Microdialysis Analyzer (CMA 600 or ISCUS). This analysis happens on the collected fluid (dialysate) which is outside the patient's body.
- Provides information for diagnosis or therapy: While it's an "adjunct monitor" and not the sole basis for decisions, the intended use is to provide "additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern." This data is used to inform clinical decisions related to diagnosis or therapy.
The process of collecting a sample (dialysate) from the patient and then analyzing that sample outside the body to obtain information about the patient's health status is the core function of an IVD device.
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
- ISCUS Clinical Microdialysis Analyzer or CMA 600 Microdialysis Analyzer 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, semi-permeable 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 Microdialysis Analyzer (CMA 600 or ISCUS). 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 analyzer 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
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
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
2 2006 MAY
D4403P169 .... doc
Kobossy
510(k) Summary for CMA Cerebral Tissue Monitoring System
1. Submitters name and address
CMA/Microdialysis AB Box 2 SE-171 18 Solna Sweden
2. Contact person and telephone number
U.S. official correspondent: Ms Nancy Blanco, General Manager, CMA/Microdialysis Inc. Telephone: 978-251-1940, ext. 30
Contact Person for this submission: Mr. Mats Premfors Quality & Regulatory Affairs Manager, CMA/Microdialysis AB, Telephone: (011) 46 8 470 1080
3. Date Prepared
February 24, 2006
4. Device name and classification
| Proprietary Name: | CMA Cerebral Tissue Monitoring System |
|---|---|
| Common/Usual Name: | Brain Ischemia/Hypoxia Monitoring System |
| Classification Name: | Intracranial Pressure Monitoring Device, |
| Product code | GWM |
| Class | II |
| Regulation number | 21 CFR 882.1620 |
| Classification Panel: | Neurology Device Panel |
5. Predicate device
CMA 600 Cerebral Tissue Monitoring System, K020285
CMA/Microdialysis AB, 510(k) February 24th, 2006 CMA Cerebral Tissue Monitoring System
Section 3, Page 1 (2)
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1
6. 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 ・
- -ISCUS Clinical Microdialysis Analyzer or CMA 600 Microdialysis Analyzer 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, semi-permeable 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 Microdialysis Analyzer (CMA 600 or ISCUS). 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 analyzer showing the local changes in the hypoxic/ischemic state of the brain tissue.
7. Intended 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.
8. Comparison of technical charecteristics
The functionality for the CMA Cerebral Tissue Monitoring System with ISCUS is equivalent to its predicate device CMA 600 Cerebral Tissue Monitoring System (K020285) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510(k) submission.
CMA/Microdialysis AB, 510(k) February 24th, 2006 CMA Cerebral Tissue Monitoring System
Section 3, Page 2 (2)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY
2 2005
CMA Microdialysis AB c/o CMA/Microdialysis, Inc. Ms. Nancy Blanco Vice President & General Manager 73 Princeton Street North Chelsmford, Massachusetts 01863
Re: K060554
Trade/Device Name: CMA Cerebral Tissue Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: April 10, 2006 Received: April 18, 2006
Dear Ms. Blanco:
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
3
Page 2 - Ms. Nancy Blanco
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 5- Indications for Use Statement
510(k) Number (if known)
Re
Device Name
Indications for Use
KO60554
CMA Cerebral Tissue Monitoring System
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.
Prescription Use x (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH. Office of Device Evaluation (ODE)
.Q.mde
(Division Sign-O Division of General, Restorative, and Neurological Devices
K060554 510(k) Number_
CMA/Microdialysis AB, 510(k) February 24th, 2006 CMA Cerebral Tissue Monitoring System
Section 5, Page 1 (1)