(161 days)
Not Found
Not Found
No
The description focuses on standard spirometry measurements, data storage, and basic visual indicators based on physician-defined criteria. There is no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an "electronic measurement device to monitor the lung function," indicating a diagnostic rather than therapeutic purpose. It measures and provides information but does not actively treat a condition.
Yes
Explanation: The device monitors lung function by measuring respiratory flows and volume, and calculates parameters like FEV1, FVC, and FEF25-75, which are used to monitor respiratory status in conditions like asthma and COPD. This collection and analysis of physiological data for health monitoring constitutes a diagnostic purpose.
No
The description explicitly states the device is an "electronic measurement device" that "measures the flow during expiration," indicating it includes hardware components for physical measurement.
Based on the provided text, the Asthma Monitor AM2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AM2 Function: The AM2 directly measures physiological parameters related to lung function (respiratory flows and volume) by having the patient breathe into the device. It does not analyze biological specimens.
The AM2 is a medical device used for monitoring lung function in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
N/A
Intended Use / 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.
Product codes
73 BZG
Device Description
The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume). The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75. The device informs the patient of the results by numeric values for selected parameters (e.g. PEF, FEVI) and provides a visual control unit displayed as a kind of traffic lights for immediate indication. The device saves measurement results (with date and time) automatically in an internal database, with memory capacity for up to 400 measurements. It also offers a questionnaire functionality usable with the AMOS software package, allowing programming of up to 12 questions with up to 7 answers, which are stored internally and can be transmitted to a PC. The AM2 is designed to replace ordinary peak flow meters, diaries, and pencils, offering easy handling, sturdy, and handy design for use in various settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung / respiratory system
Indicated Patient Age Range
human beings
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three heads or faces.
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.
1
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
2
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)