(161 days)
The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.
The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
The provided document (K980876) is a 510(k) clearance letter for the "Asthma Monitor AM2" and an "Indications For Use" statement. It does not contain a study describing acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a clinical study as requested.
The document indicates that the device is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness were likely established based on its similarity to existing devices, rather than a new standalone clinical study with detailed acceptance criteria and performance metrics.
Therefore, I cannot provide the requested information from this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 4 |998
Mr. Detlef Grotheer Erich Jaeger GmbH LeibnizstraBe 7 D-97204 Höchberg GERMANY
K980876 Re : Asthma Monitor AM2 Regulatory Class: II (Two) Product Code: 73 BZG Dated: July 10, 1998 Received: July 13, 1998
Dear Mr. Grotheer:
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 Cosmetic Act (Act). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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. Detlef Grotheer
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 diaqnostic 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,
Thomas J. Allelston
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
ASTHMA MONOTOR AM2
Indications For Use:
The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.
The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life' status. When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
Caution: Federal law restricts this device to sale by or on the order of a physician.
June-26-98
Achim Schülke
Product Manager
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Louth W. Medow 8-12-98
(Division Sign-Off)
Division of Cardiovascular, Respiratory, Prescription Use and Neurological Devices Over-The-Counter 510(k) Number _
(Per 21 CFR 801.109)
Use
(Optional Format 1-2-96)
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).