(154 days)
No
The description focuses on standard electronic measurement, data storage, and transmission, with 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" and a "medical device (peak flow meter with symptom diary)," which measures parameters like PEF and FEV1. Its primary purpose is monitoring and providing information for assessing respiratory status, not directly treating a condition.
Yes
Explanation: The device "monitor[s] the respiratory status of adult human beings in the areas of asthma, chronic obstructive pulmonary disorder." While it doesn't provide a definitive diagnosis on its own, monitoring for a specific medical condition is a form of diagnostic support. It measures parameters like PEF and FEV1, and provides immediate indications based on physician-defined criteria, which contribute to diagnosing or managing a condition.
No
The device description explicitly states it is a "Handheld device" and lists hardware components like a flow sensor and mouthpiece, indicating it is a physical device with accompanying software, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Asthma Monitor AM3/AM3 GSM measures respiratory flows and volume directly from the patient's breath.
- The intended use is to monitor lung function in vivo (within the living body). It's a direct measurement of a physiological process, not an analysis of a biological sample.
- The device description focuses on measuring physical parameters (flow and volume) of respiration. It doesn't mention any reagents, assays, or analysis of biological specimens.
Therefore, the Asthma Monitor AM3/AM3 GSM is a medical device used for in vivo monitoring of respiratory function, not an IVD.
N/A
Intended Use / Indications for Use
The Asthma Monitor AM3/AM3 BT/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas of 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 the selected parameters (e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form 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. In addition, 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 AM3 can be programmed with a couple of questions, where the patient can then select from a couple of 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 AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 to be used in healthcare, clinical and home use environments/settings.
Product codes
BZG
Device Description
The Asthma Monitor AM3 GSM is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device
- Battery operation
- Storing capacity of 1200 measurements
- Storing capacity of 400 sets of questionnaires (max. 20 questions each)
- Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 1/min
- Accuracy Volume: ± 3% or ± 0.05 liter
- Data transmission to computer/database via USB, Bluetooth, GSM and Serial (RS232)
- Flow sensor (single patient use)
- Mouthpiece (single patient use)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
The Asthma Monitor can be used for patients from 4 years on and older. (Note: The Indications for Use states adult human beings, but the comparison table clarifies "The Asthma Monitor can be used for patients from 4 years on and older.")
Intended User / Care Setting
healthcare, clinical and home use environments/settings
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)
- The GSM data transmission for the above device was developed in accordance with the eResearchTechnology development standard operating procedures.
- The risk analysis method used to assess the impact of Asthma Monitor AM3 / AM3 BT with the additional GSM data transmission was a Failure Modes and Effects Analysis (FMEA).
- Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
- The EMC testing was performed according EN 60601-1-2.
- The GSM module was tested according to R&TTE and FCC guidelines.
- The software was developed according to the IEC 62304 Standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Flow: ± 5% or ± 20 1/min
Accuracy Volume: ± 3% or ± 0.05 liter
Predicate Device(s)
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
MAY 0 8 2014
510(k) Summary
GENERAL INFORMATION
5.1 Type of Submission
Special 510(k) Submission
Submission date: 12/02/2013
5.2 Submitter
Name: eResearchTechnology GmbH
Address:
Sieboldstrasse3 D-97230 Estenfeld Germany
Contact person in Germany:
Address:
Phone:
FAX:
Johannes Thalhammer eResearchTechnology GmbH Sieboldstrasse 3, 97230 Estenfeld Germany +49 9305 720 6376 +49 9305 720 60 johannes.thalhammer@ert.com
Contact person in the U.S .: (Official Correspondent) Address
Richard Miller
eResearchTechnology 1818 Market Street, Suite 1000 Philadelphia, PA 19103
Phone/Fax: E-mail
215-2825588 RMiller@ert.com
,
1
5 510(k) Summary
- 5.3 Establishment Registration Number 3008505660
- 5.4 Common Name or Classification Name Diagnostic Spirometer (CFR 868.1840, Product Code BZG)
5.5 Trade Name
Asthma Monitor AM3 / AM3 BT / AM3 GSM
5.6 Device Classification
This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868 Code BZG
5.8 Reason for Premarket Notification
Device modification to an existing device regarding "The New 510(k) Paradigm"
-
Additional data transfer to Database by GSM;
-
Li-lon battery - is used as energy type
5.9 Legally predicate marketed device
Asthma Monitor AM3/AM3 BT K092890 Code BZG
Predicate Device Company 5.10
eResearchTechnology GmbH (device was formally listed by Carefusion Germany 234 GmbH)
Device Description 5.11
The Asthma Monitor AM3 GSM is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device ●
- Battery operation .
- Storing capacity of 1200 measurements .
- Storing capacity of 400 sets of questionnaires (max. 20 questions each ) .
- . Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 1/min .
- . Accuracy Volume: ± 3% or ± 0.05 liter
- Data transmission to computer/database via USB, Bluetooth, GSM and . Serial (RS232)
- Flow sensor (single patient use) .
- . Mouthpiece (single patient use)
2
Intended Use Statement 5.12
The Asthma Monitor AM3/AM3 BT/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas of 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 the selected parameters (e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form 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. In addition, 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 AM3 can be programmed with a couple of questions, where the patient can then select from a couple of 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 AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 to be used in healthcare, clinical and home use environments/settings.
5.13 Required Components
AM3 / AM3 BT /AM3 GSM measurement device Accessories User Manual
5.14 Summary Table of Comparison
- a) Comparison with Asthma Monitor AM3/AM3 BT with 510(k) K092890
| | Asthma Monitor
AM3/AM3 BT
(K092890) | Asthma Monitor
AM3 GSM | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an
electronic measurement device
to monitor the lung function | The Asthma Monitor AM3/AM3/AM3 GSM is an electronic
measurement device to monitor
the lung function (determination | |
| (determination of the respiratory
flows and volume) with high
reproducibility wherever and
whenever is a need of. The
AM3 / AM3 BT measures the
flow during expiration serving
for the calculation of further
parameters as FEV1. | of the respiratory flows and
volume) with high reproducibility
wherever and whenever is a
need of. The AM3 measures the
flow during expiration serving far
the calculation of further
parameters as FEV1. | | |
| The AM3 / AM3 BT 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 AM3 is used to monitor the
respiratory status of human adult
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,
FEV1). 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 patient is informed of the
results by numeric values for
selected parameters (e.g. PEF,
FEV1). 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 AM3 / AM3 BT can
be programmed with a couple of
questions, where the patient
can select then from a couple of
different answers | 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 AM3 / AM3 BT can
be programmed with a couple of
questions, where the patient
can select then from a couple of
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 AM3 / AM3 BT is designed
to replace ordinary peak flow
meter, diary and pencil by a
single system. Easy handling,
sturdy and handy design allow
the AM3 / AM3 BT being used
almost everywhere: at work, at
home, in school, for experts
opinion, research or clinical trial
purposes and in occupational
medicine. | The device saves the results of a
measurement (always with date
and time) automatically in an
internal database.
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 AM3 can be
programmed with a couple of
questions, where the patient can
select then from a couple of | internal database.
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 AM3 can be
programmed with a couple of
questions, where the patient can
select then from a couple of
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 AM3 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
AM3 being used in healthcare,
clinical and home use
environments/settings, for expert
opinion, research or clinical trial
purposes and in occupational
medicine. |
| | | > Besides minor wording
changes the Intended Use is
identical to K092890 (see italic
text in Intended Use of to
K092890) | |
| Patient
population | The Asthma Monitor can be
used for patients from 4 years
on and older. | identical | |
| | Length x Width x Height:
1128237 mm | Length x Width x Height:
1128237 mm | |
| Dimensions
(housing) | Weight:
167 g (batteries included) | Weight:
120 g (batteries included) | |
| Display | LCD module
Size: 54,0 x 33,5 mm
255 x 160 dots | Identical | |
| | Foil Key-panel (4 keys): | | |
| Key-panel | - ESC (on/off)
- UP-ARROW
- DOWN-ARROW
- OK | identical | |
| Integrated
mouthpiece
(material) | Polysterol 454C | identical | |
| Single Use
mouthpiece
(material) | Bormed RG835 MO | identical | |
| | Parameters: | | |
| Performance
(measurements) | PEF
FEV1 | identical | |
| Interface | Serial RS 232 & USB &
Blue-tooth | Serial RS 232 & USB &
Blue-tooth & GSM | |
| Energy type | 3 x 1,5 (Micro AAA) | LI-ION Polymer battery 3.7 V,
1700 mAh | |
| Operating
Require-
ments | PC software AMOS | identical | |
| Bluetooth | WML-C46 (Mitsumi) | identical | |
| | | | |
| interface | | | |
| GSM
Interface | none | Sierra Wireless
WISMO288 | |
3
5 510(k) Summary
.
.
4
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Page 5 of 7
ﻧﮯ
.
5
Discussion of the table above:
The insignificant difference to the AM3/AM3 BT (K092890) is:
- GSM is used for wireless data transfer to a Database as an additional . possibility besides the serial, USB and BlueTooth interface communication. GSM (Global System for Mobile communications) is an open, digital cellular technology used for transmitting mobile voice and data services. The in-built GSM module is used instead of an external cell phone paired to the AM3 BT to transmit the data to a database.
- The device performance is not affected by adding the GSM function, as the ● data transfer is offline and will not take place when a measurement is active or a questionnaire is performed.
- . As the data transfer is offline to the measurement or questionnaire functionality and all data is stored in a nonvolatile memorv. The availability of reception to the GSM is not critical, as the data transfer could be done at any time without any influence to the device functionality.
- . The wireless transfer is based on the use of the GSM module Sierra Wireless WISMO288. The GSM module uses techniques to guarantee the integrity of the transferred data. Latency and throughput is part of the GSM module implementation. The use of the qualified GSM module ensures that the latency and throughput requirements were met.
- Minor modifications of the software concerning the GSM module are . verified. The software requirements and design specifications submitted, include requirements and specifications of the entire device. Based on the recommendations of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" only verification reports related to the modifications which caused the need for a Special 510(k) are submitted.
- . The Applicable EMC and telecommunications standards and regulations, including device emissions that may cause EMI with other equipment are fulfilled.
- · Li-lon battery is used as energy type. The battery has to be charged by a power supply. The Li-Ion battery and the power supply fulfil the common standards and were implemented and tested for safe and effective use.
5.15 Summary of Device Testing
The following practices were followed and monitored for development of the Asthma Monitor AM3 with the GSM data transmission:
- . The GSM data transmission for the above device was developed in accordance with the eResearchTechnology development standard operating procedures.
6
- The risk analysis method used to assess the impact of Asthma Monitor . AM3 / AM3 BT with the additional GSM data transmission was a Failure Modes and Effects Analysis (FMEA).
- Safety test procedures demonstrate satisfaction of all safety . requirements and mitigation of all identified hazards.
- The EMC testing was performed according EN 60601-1-2. .
- The GSM module was tested according to R&TTE and FCC guidelines. .
- The software was developed according to the IEC 62304 Standard. .
5.16 Conclusions
Based on the above, eResearchTechnology concludes that the Asthma Monitor AM3 with the "GSM" data transmission module does not raise new questions of safety and effectiveness and is as safe and as effective for its intended use, and performs at least as well as the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD. 20993-0002
May 8, 2014
eResearchTechnology GmbH Richard Miller Vice President, Quality Management 1818 Market Street, Suite 1000 Philadelphia, PA 19103
Re: K133722
Trade/Device Name: Asthma Monitor AM3 GSM Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: April 07, 2014 Received: April 08, 2014
Dear Mr. Miller:
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.
8
Page 2 - Mr. Miller
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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Sincerely yours,
Image /page/8/Picture/7 description: The image contains a logo with text. The text includes the words "Clinical Deputy Director" and "DAGRID/ODE/CDRH". The logo appears to be for an organization or department, possibly related to clinical or regulatory affairs. The image quality is low, making it difficult to discern finer details.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): KI33722
Device Name:
АМЗ AM3 BT AM3 GSM
Indications for Use:
The Asthma Monitor AM3/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas of 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 the selected parameters (e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form 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. In addition, 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 AM3 can be programmed with a couple of questions, where the patient can then select from a couple of 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 AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 to be used in healthcare, clinical and home use environments/settings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
: . .
Anya C. Harry -(1) 2017 19:15:14 PM S 2014.05.08
06:07:44 -04'00'
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