CMA CEREBRAL TISSUE MONITORING SYSTEM

K060554 · Cma Microdialysis AB · GWM · May 2, 2006 · Neurology

Device Facts

• Record ID: K060554
• Device Name: CMA CEREBRAL TISSUE MONITORING SYSTEM
• Applicant: Cma Microdialysis AB
• Product Code: GWM · Neurology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Special
• 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 uses microdialysis to monitor brain tissue biochemistry. CMA 70 catheter, placed in brain tissue, acts as artificial capillary; interstitial fluid molecules diffuse across semi-permeable membrane into perfusion fluid pumped by CMA 106 pump. Collected dialysate is analyzed by ISCUS or CMA 600 analyzer for glucose, lactate, and pyruvate concentrations. Analyzer displays trend curves of these markers. Used in clinical settings by hospital staff to provide supplemental data on cerebral perfusion status. Output assists clinicians in evaluating local hypoxic/ischemic state; not for sole diagnostic or therapeutic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical characteristics and functional comparison to the predicate device.

Technological Characteristics

System components: CMA 70 brain microdialysis catheter, CMA 106 pump, perfusion fluid, microvials, and ISCUS/CMA 600 analyzers. Sensing principle: microdialysis (diffusion across semi-permeable membrane). Analyzes glucose, lactate, and pyruvate concentrations. Connectivity: analyzer displays trend curves. Software: analyzer-based processing of biochemical concentrations.

Indications for Use

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

• CMA 600 Cerebral Tissue Monitoring System (K020285)

Submission Summary (Full Text)

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#### 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: [phone], ext. 30

Contact Person for this submission: Mr. Mats Premfors Quality & Regulatory Affairs Manager, CMA/Microdialysis AB, Telephone: [phone]

## 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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### 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)

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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

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# 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 [phone]. 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 [phone] or [phone] 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

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### 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)