(413 days)
The CORTEX METALYZER pulmonary function stationary test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive nulmonary function values using the monitored and derived parameters. This device is for use in a laboratory or facility setting and may be used with adults and children over the age of 14 years.
The CORTEX METALYZER metabolic test system is a stationary device, which can monitor parameters during laboratory testing or simulated conditions. The device is comparable to the Jaeger Oxycon Alpha system. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
The provided text describes a 510(k) summary for the CORTEX METALYZER, a metabolic test system. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document primarily focuses on:
- Device Description and Comparison: Stating that the CORTEX METALYZER is a stationary device that monitors parameters during laboratory testing, comparable to the Jaeger Oxycon Alpha system. It highlights software, electrical operation, and component similarities/differences (e.g., oxygen sensor type).
- Intended Use: For monitoring cardio-respiratory functions during stress testing, rehabilitation, sports medicine, and other related activities, providing predictive pulmonary function values, and being used in a laboratory/facility setting for adults and children over 14.
- Substantial Equivalence: The FDA's letter confirming that the device is substantially equivalent to a legally marketed predicate device (K980094).
Therefore, I cannot populate the requested table and details because the necessary information is not present in the given text.
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DEC 1 4 2000 1
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
AJW Technology Consultants, Inc. 962 Allegro Ln. Apollo Beach, FL 33572
Phone: 813-287-2382 Fax: 813-287-8866
Contact Person:
Art Ward
Date of Summary:
September 1, 1999
Trade Name:
CORTEX METALYZER
Classification Name:
Predictive Pulmonary Function Value Calculator 21 CFR Section 868, 1890
Oxycon Alpha
Predicate Device:
Device Description/ Comparison:
The CORTEX METALYZER metabolic test system is a stationary device, which can monitor parameters during laboratory testing or simulated conditions. The device is comparable to the Jaeger Oxycon Alpha system.
Jaeger
The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
Intended Use:
The METALYZER is a pulmonary function stationary test system which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive pulmonary function values are calculated based upon the data obtained during testing.
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510(K) Summary Differences and Similarities
As reviewed in Section 10 the Metalyzer pulmonary system is fundamentally similar to the predicate device. This summary reviews the:
Intended Use Applications Usage Location Technological characteristics
Intended Use:
Both the Metalyzer and predicate device have the same intended use.
Applications:
Both products are used in applications such as stress testing, rehabilitation, sports research and medicine and occupational medicine.
Usage Location:
The Metalyzer and predicate device are designed for use within a laboratory or facility setting.
Technological Characteristics:
These products have very similar technology in their components.
Similarities:
Volume Transducer - Both use digital rotameter. Carbon Dioxide Sensor - Non-dispersive infrared in both systems. Heart Rate Sensor - Polar Belt used in both units. Data Collection - A choice of mask or mouthpiece for collecting data offered in both. Predictive Value Calculations - Both systems measure the same values and then oalulate values for pulmonary function.
Differences:
Oxygen Sensor – The Metalyzer uses a Galvanic Fuel Cell while the predicate device a Paramagnetic Cell. Both types are considered standard technology & or oxygen measurement.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2000
Mr. Arthur J. Ward Cortex Biophysik GmbH c/o AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572
Re: K993641 Metalyzer, Model 2: Metalyzer, Model 3 Requlatory Class: II (two) 73 BTY Product Code: September 13, 2000 Dated: September 15, 2000 Received:
Dear Mr. Ward:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 You may, therefore, market the device, subject to Cosmetic Act (Act). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Arthur J. Ward
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
James E. Dillard III
Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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K993641 510(k) Number (if known):
CORTEX METALYZER MetabolicTest System Device Name:
Indications For Use:
The CORTEX METALYZER pulmonary function stationary test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive nulmonary function values using the monitored and derived parameters. This device is for use in a laboratory or facility setting and may be used with adults and children over the age of 14 years.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of Cardiovascular & Respiratory Devices
510(k) Number K993641
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).