(344 days)
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.
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, glycerol and glutamate
- Control Samples l
- 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.
The provided text does not contain information regarding an acceptance criteria table, device performance metrics, sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, types of ground truth, or details about the training set.
The document is a 510(k) summary for the CMA Cerebral Tissue Monitoring System, outlining its description, intended use, and comparison to predicate devices, and a letter from the FDA issuing a substantial equivalence determination. It focuses on regulatory approval based on equivalence rather than performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
{0}------------------------------------------------
07,984
D5073P118 ....doc
510(k) Summary
for
CMA Cerebral Tissue Monitoring System
JUN 2 7 2008
1. Submitters name and address
CMA/Microdialysis AB Box 2 SE-171 18 Solna Sweden
Contact person and telephone number 2.
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
June 26th, 2007
Device name and classification 4.
Proprietary Name: Common/Usual Name: Classification Name: Product code Class Regulation number Classication Panel:
CMA Cerebral Tissue Monitoring System Brain Ischemia/Hypoxia Monitoring System Intracranial Pressure Monitoring Device, GWM II 21 CFR 882.1620 Neurology Device Panel
- Predicate device
CMA 600 Cerebral Tissue Monitoring System, K020285 CMA Cerebral Tissue Monitoring System, K060554
CMA/Microdialysis AB, 510(k) CMA Cerebral Tissue Monitoring System June 26th, 2007
Section 3, Page 1 (2)
{1}------------------------------------------------
Device Description 6.
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, glycerol and glutamate
- Control Samples l
- 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, 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.
8. Comparison of technical characteristics
The CMA Cerebral Tissue Monitoring System is equivalent to its predicate devices in safety and effectiveness. The components of the system, as listed above, have not been changed; the two reagents glycerol and glutamate have been added. The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
CMA/Microdialysis AB, 510(k) June 26th, 2007 CMA Cerebral Tissue Monitoring System
Section 3, Page 2 (2)
Page 16 of 448 omplete 510k
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
CMA Microdialysis AB % CMA Microdialysis, Inc. Ms. Nancy Blanco VP & General Manager 73 Princeton Street North Chelmsford, Massachusetts 01863
Re: K071984
Trade/Device Name: CMA Cerebral Tissue Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracraial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: June 13, 2008 Received: June 17, 2008
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
D5075P118 ....doc
Section 5- Indications for Use Statement
510(k) Number (if known)
Device Name
Indications for Use
07198
CMA Cerebral Tissue Monitoring System
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.
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)
D
(Division Sign. Off.
on Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number /671974
CMA/Microdialysis AB, 510(k) CMA Cerebral Tissue Monitoring System June 26th, 2007
Section 5, Page 1 (1)
Page 22 of 448 Complete 510k
§ 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).