CMA CEREBRAL TISSUE MONITORING SYSTEM

K020285 · Cma Microdialysis AB · GWM · Oct 23, 2002 · Neurology

Device Facts

• Record ID: K020285
• Device Name: CMA CEREBRAL TISSUE MONITORING SYSTEM
• Applicant: Cma Microdialysis AB
• Product Code: GWM · Neurology
• Decision Date: Oct 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

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.

Device Story

System utilizes microdialysis to monitor cerebral ischemia markers. CMA 70 Brain Microdialysis Catheter, inserted into brain tissue, mimics blood capillary; interstitial fluid molecules diffuse across semipermeable membrane into pumped Perfusion Fluid. Collected dialysate samples are analyzed by CMA 600 Microdialysis Analyser for glucose, lactate, and pyruvate concentrations. Hospital staff manage sample collection and analysis. Device displays trend curves of biochemical markers on CMA 600 screen. Clinicians use these relative trends as adjunctive data alongside standard clinical practice to evaluate cerebral perfusion status; not for sole diagnostic or therapeutic decision-making. Benefits include additional insight into hypoxic/ischemic state of brain tissue.

Clinical Evidence

No specific clinical trial data or performance metrics (sensitivity/specificity) provided in the summary. Substantial equivalence is supported by reference to numerous clinical studies demonstrating correlations between biochemical markers and established intracranial monitoring parameters in brain-injured patients.

Technological Characteristics

System components: CMA 70 Brain Microdialysis Catheter (semipermeable membrane), CMA 106 Pump, CMA 600 Microdialysis Analyser, reagents, and microvials. Sensing principle: microdialysis-based diffusion of interstitial fluid molecules. Connectivity: standalone analyzer. Software: integrated into CMA 600 for data processing and trend display.

Indications for Use

Indicated for patients where cerebral ischemia or hypoxia is a concern, requiring adjunctive monitoring of intracranial glucose, lactate, and pyruvate levels to assess local tissue perfusion status.

Regulatory Classification

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.

Predicate Devices

• LICOX Brain Oxygen Monitoring system, CMP® Monitor and IMC® Systems (K002765)
• CODMAN Neurotrend Multiparameter Sensor (K980380)

Submission Summary (Full Text)

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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.

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#### 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

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)