MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

{0}------------------------------------------------ D7387 K102077 # 510(k) Summary for # CMA Cerebral Tissue Monitoring System JAN 1 4 201 #### Submitters name and address 1. CMA Microdialysis AB Box 2 SE-171 18 Solna Sweden #### Contact person and telephone number 2. Contact Person for this submission: Mr. Mats Premfors Quality & Regulatory Affairs Manager, CMA Microdialysis AB, Telephone: (011) 46 8 470 1080 U.S. official correspondent: Ms Nancy Blanco, General Manager, CMA Microdialysis Inc. Telephone: . 978-251-1940, ext. 230 ### 3. Date Prepared October 5th , 2010 #### Device name and classification 4. | 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 | #### ડ. Predicate device CMA Cerebral Tissue Monitoring System, K071984 Previous submissions modified: CMA Cerebral Tissue Monitoring System, K060554 CMA 600 Cerebral Tissue Monitoring System, K020285 {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 - - Microdialysis Analyzer (CMA 600, ISCUS or ISCUS108) - - -Reagents lactate, pyruvate, glucose, glycerol and glutamate - -Control Samples - Rinsing Fluid - - -Calibrator A The 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. The microdialysis samples are analyzed in the Microdialysis Analyzer for the concentrations of glucose, lactate, pyruvate, glycerol and glutamate, 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, pyruvate, glycerol and glutamate 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. #### Comparison of technical characteristics 8. The functionality for CMA Cerebral Tissue Monitoring System is equivalent to its predicate device CMA Cerebral Tissue Monitoring System (K071984). The fundamental technical characteristics are similar to those of the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002 CMA Microdialysis, Inc. c/o Ms. Nancy Blanco Vice President & General Manager 73 Princeton Street North Chelmsford, MA 01863 JAN 1 4 2011 Re: K102077 Trade Name: CMA Cerebral Tissue Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: December 16, 2010 Received: December 17, 2010 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {3}------------------------------------------------ Page 2 - Ms. Nancy Blanco 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Kesia Alexander Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Section 5- Indications for Use Statement 510(k) Number (if known) | Device Name | CMA Cerebral Tissue Monitoring System | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, pyruvate, glycerol and glutamate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement.<br>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. | X Prescription Use (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) (Division Sign Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number. K102077 Prescription Use (Per 21 CFR 801.109) X October 4th, 2010