(290 days)
AM3 GSM K133722
AM3 GSM K133722
No
The document describes a device that measures lung function and records data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The "traffic light" system is based on physician-defined thresholds, not learned patterns.
No
The device is described as an electronic measurement device to monitor lung function, not to provide therapy or treatment. Its primary function is to measure and track respiratory parameters.
Yes
The device measures physiological parameters (respiratory flows and volume) to monitor lung function, and the results are primarily used by a physician to make a diagnosis and determine appropriate therapeutic treatments.
No
The device description explicitly states it is a "Handheld device" and includes hardware components like a "Rotary Flow Sensor" and "Battery operation." It also mentions hardware verification and validation.
Based on the provided information, the Asthma Monitor AM3 G+ 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 (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AM3 G+ Function: The AM3 G+ measures respiratory flows and volume directly from the patient's breath (an in vivo measurement), not from a specimen taken from the body. It monitors lung function and collects patient-reported data (symptoms and medications).
- Intended Use: The intended use is to monitor the respiratory status of individuals, not to analyze biological samples.
- Device Description: The device description focuses on the measurement of breath parameters (PEF, FEV1) and the collection of diary information.
Therefore, the Asthma Monitor AM3 G+ falls under the category of a medical device that performs physiological measurements directly on the patient, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Asthma Monitor AM3 G+ 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 human beings (adults and children 5 years and older) 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, (symptom and medications) questionnaire functionality can be called up by the use of a software (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 using the software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.
Product codes
BZG
Device Description
The Asthma Monitor AM3 G+ is a medical device (peak flow meter with symptom diary) providing following design and performance 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 I/min
- . Accuracy Volume: ± 3% or ± 0.05 litre
- Wireless communication with computer/mobile device/database via Bluetooth and mobile communication (3G, TCP/IP) by using accessory software AMOS
- . Rotary Flow Sensor (single patient use)
The Asthma Monitor AM3 G+ is an instrument that combines a peak flow meter with a symptom and medication diary. This device displays questions concerning symptoms and medication to be answered twice a day and measures and evaluates the Peak Flow (PEF = Peak Expiratory Flow [l/min]) and FEV1 (Forced Expiratory Volume in 1 second [1]).
The AM3 G+ keeps a diary of patient measurements by automatically recording all answers and PEF measurements with the date and time in its memory. Data can be collected for approximately 100 days. Every time the patient visits the centre, the data will be downloaded by using AMOS software. Additionally the data can be exchanged to a predefined database using the 3G mobile communication module (SMS, TCP/IP).
Scheduled sessions, including questionnaire and PEF measurements, can be configured wirelessly using AMOS software, performed and stored with the AM3 G+. Following the study protocol, the patient has to carry out scheduled sessions twice a day.
In the morning and the evening session, there is a set of questions to be answered before a scheduled PEF measurement can be performed. As soon as the patient switches on the AM3 G+ for the first time during one of the time windows, the first question of the appropriate questionnaire will be displayed.
AMOS is a stand-alone software for the professional user (physician/clinical staff) for configuration, parameter processing and data display. It does not provide a diagnosis or treatment suggestions. Diagnosis and appropriate therapeutic treatments are only made by the physician. The AMOS software allows to set and adjust individual thresholds which are based on international and national standards such as ATS and ERS. They are based on the patient's individual best value which is determined by the doctor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adults and children 5 years and older
Intended User / Care Setting
health care, clinical and home use environments.
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)
Performance Testing:
- The device was developed and tested according to GMP Standard Operating Procedures for Medical Devices.
- Software verification and validation was done in accordance with IEC 62304:2006 + A1:2015.
- Risk analysis was performed according to ISO 14971:2007.
- Tests were performed to confirm that the Asthma Monitor meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS 2005 standards.
- The electrical safety testing was performed according to IEC 60601-1:2012 and IEC 60601-1-11:2015 to demonstrate conformance with the requirements for basic safety and essential performance.
- The Electro Magnetic Compatibility testing was performed according to IEC 60601-1-2:2014.
- The FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" issued on August 14, 2013 was considered for the 3G/BT functions and all requirements are fulfilled.
- BT and 3G functions of the Asthma Monitor AM3 G+ were tested according to the Federal Communications Commission's rules and regulation in Title 47 of the Code of Federal Regulations to demonstrate conformity with defined frequency bands and frequencies for the different spectrum allocations.
- The FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" from 2014 has been considered in the device design and all requirements are fulfilled.
The verification and validation activities for hardware and software were performed and the results demonstrated that the predetermined acceptance criteria were met.
Biocompatibility:
There have been no changes in material and biocompatibility. All material used is identical to the predicate device. The manufacturing process is identical to the predicate device.
The Rotary Flow Sensor is exactly the same as already used in the predicate device and among all Asthma Monitor devices.
No new biocompatibility testing was done, as the biocompatibility testing for the predicate device remains effective for this submission.
Clinical Testing: No clinical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Flow: ± 5% or ± 20 l/min
Accuracy Volume: ± 3% or ± 0.05 litre
Predicate Device(s)
AM3 GSM K133722
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2019
eResearchTechnology Mingzi Deng Senior Regulatory Affairs Specialist 500 Rutherford Avenue Boston, Massachusetts 02129
Re: K183479
Trade/Device Name: Asthma Monitor AM3 G+ Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG Dated: August 29, 2019 Received: September 3, 2019
Dear Mingzi Deng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183479
Device Name Asthma Monitor AM3 G+
The Asthma Monitor AM3 G+ is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV 1.
The AM3 is used to monitor the respiratory status of human beings (adults and children 5 years and older) 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, FEV ). 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, (symptom and medications) questionnaire functionality can be called up by the use of a software (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 using the software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is made up of three curved shapes in green and blue. Below the text "ERT" is the tagline "Confidence at every turn".
GENERAL INFORMATION
| 1 | Type of Submission
Special 510(k) Submission
Date 510(k) summary prepared: 10/03/2019 |
|----------|----------------------------------------------------------------------------------------------------|
| 2 | Submitter |
| | Name: eResearchTechnology GmbH |
| | Address: Sieboldstrasse3
D-97230 Estenfeld
Germany |
| | Contact person in Germany:
(Official Correspondent) Kristin Feld |
| | Address: eResearchTechnology GmbH
Sieboldstrasse 3, 97230 Estenfeld
Germany |
| | Phone: +49 9305 720 6377
FAX: +49 9305 720 60
E-mail kristin.feld@ert.com |
| | Contact person in the U.S.: Mingzi Deng |
| | Address eResearch Technology
500 Rutherford Avenue
Boston, MA 02129 |
Phone/Fax: +1 617 681 6010 E-mail mingzi.deng@ert.com
- 3 Establishment Registration Number
3008505660
4 Common Name or Classification Name
Diagnostic Spirometer (21 CFR 868.1840, Product Code BZG)
5 Trade Name
Asthma Monitor AM3 G+
4
Image /page/4/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored blue, green, and blue. Below the text "ERT" is the tagline "Confidence at every turn".
- 6 Device Regulatory Classification
This is a Class II device
7 Classification Panel and Product Code
73 Anesthesiology Part 868 Code BZG
Reason for Premarket Notification 8
Modification of an existing device regarding "The New 510(k) Paradigm"
- Additional data transfer capabilities via TCP/IP
- Change in operating system of device accessory software AMOS
9 Legally predicate marketed device
Asthma Monitor AM3 GSM K133722 Code BZG
Predicate Device Company 10
eResearchTechnology GmbH
11 Device Description
The Asthma Monitor AM3 G+ is a medical device (peak flow meter with symptom diary) providing following design and performance 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 I/min
- . Accuracy Volume: ± 3% or ± 0.05 litre
- Wireless communication with computer/mobile device/database via Bluetooth and mobile communication (3G, TCP/IP) by using accessory software AMOS
- . Rotary Flow Sensor (single patient use)
The Asthma Monitor AM3 G+ is an instrument that combines a peak flow meter with a symptom and medication diary. This device displays questions concerning symptoms and medication to be answered twice a day and measures and evaluates the Peak Flow
5
Image /page/5/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green and dark blue. Below the text "ERT" is the tagline "Confidence at every turn".
(PEF = Peak Expiratory Flow [l/min]) and FEV1 (Forced Expiratory Volume in 1 second [1]).
The AM3 G+ keeps a diary of patient measurements by automatically recording all answers and PEF measurements with the date and time in its memory. Data can be collected for approximately 100 days. Every time the patient visits the centre, the data will be downloaded by using AMOS software. Additionally the data can be exchanged to a predefined database using the 3G mobile communication module (SMS, TCP/IP).
Scheduled sessions, including questionnaire and PEF measurements, can be configured wirelessly using AMOS software, performed and stored with the AM3 G+. Following the study protocol, the patient has to carry out scheduled sessions twice a day.
In the morning and the evening session, there is a set of questions to be answered before a scheduled PEF measurement can be performed. As soon as the patient switches on the AM3 G+ for the first time during one of the time windows, the first question of the appropriate questionnaire will be displayed.
AMOS is a stand-alone software for the professional user (physician/clinical staff) for configuration, parameter processing and data display. It does not provide a diagnosis or treatment suggestions. Diagnosis and appropriate therapeutic treatments are only made by the physician. The AMOS software allows to set and adjust individual thresholds which are based on international and national standards such as ATS and ERS. They are based on the patient's individual best value which is determined by the doctor.
12 Indications for Use Statement
The Asthma Monitor AM3G+ 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 human beings (adults and children 5 years and older) 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, (symptom and medications)
6
Image /page/6/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circle is divided into three sections, colored green and blue. Below the text "ERT" is the tagline "Confidence at every turn".
questionnaire functionality can be called up by the use of a software (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 using the software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.
13 Required Components
AM3 G+ peak flow meter measurement device Rotary Flow Sensor AMOS software User Manual
| 14 | Comparison of technological characteristics with the predicate device |
|---|---|
| Comparison with Asthma Monitor AM3 GSM (K133722) |
| | Asthma Monitor
AM3GSM
(K133722) | Asthma Monitor
AM3 G+ |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Asthma Monitor AM3 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 | The Asthma Monitor AM3G+ 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 human
beings (adults and children 5
years and older) in the areas of
asthma, chronic obstructive
pulmonary disorder and in areas
like occupational medicine,
clinical trials and disease
management. |
| | 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. | 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,
(symptom and medications)
questionnaire functionality can be
called up by the use of a software
(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 using
the software AMOS.
The AM3 is designed to replace
an ordinary peak flow meter,
diary and pencil by a single
system. The asthma monitor AM3
is intended to be used in health
care, clinical and home use
environments. |
| Patient
population | The Asthma Monitor can be
used for patients from 4 years
on and older. | The Asthma Monitor can be
used for patients from 5 years
on and older. |
| Measurement
principle | Determination of respiratory
flow and volume via
exchangeable
infrared rotary flow sensor | Identical |
| Dimensions
(housing) | Length x Width x Height:
112 x 82 x 37 mm
Weight:
150 g (batteries included) | Identical |
| Display | LCD module
Size: 54.0 x 33.5 mm
255 x 160 dots | TFT LCD module
Size: 57.6 x 43.2 mm
320 x 240 dots |
| | Foil Key-panel (4 keys): | identical |
| Key-panel | - ESC (on/off)
- UP-ARROW
- DOWN-ARROW
- OK | |
| Integrated
mouthpiece
(material) | Styrolution PS 454N, single
patient use | identical |
| Housing of
the device
(material) | Cycoloy HC 1204HF, ROTEC
ABS 1001 FR | identical |
| Performance
(measurements) | Parameters:
PEF
FEV1
Accuracy:
PEF: $\pm$ 5% or $\pm$ 20 l/min
FEV1: $\pm$ 3% or $\pm$ 0.05 liter | identical |
| Interface | Serial RS 232 & USB &
Blue-tooth & GSM | USB & Bluetooth & 3G |
| Energy type | LI-ION Polymer battery 3.7 V,
1700 mAh | identical |
| Operating
Require-
ments | PC software AMOS
For standard PC with
Windows OS | AMOS App
Mobile application for Android
OS higher 6.x and Windows 10 |
| Bluetooth
interface | WML-C46 (Mitsumi) | BT121 (Silicon Lab) |
| Mobile
communicati
on Interface | Sierra Wireless
WISMO288 | Sierra Wireless
AirPrime HL8548 |
| Expected
operational
lifetime | 5 years | Identical |
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Image /page/7/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. Below the text is the tagline "Confidence at every turn".
8
Image /page/8/Picture/1 description: The image contains the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green, white, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn".
Differences
The subject device, AM3 G+ is equipped with a bigger screen; and it offers further advanced options for data transfer and exchange (3G/TCPIP instead of 2G). The previously integrated GSM and BT obsolete modules are replaced with the newer 3G module and a new Bluetooth module. In addition, RS-232 interface has been removed. Data was stored, exported and exchanged wirelessly with previously PC based software AMOS (cleared in K133722). The AMOS App is now modified to run on different operating systems and platforms (Windows10 and Android OS).
9
Image /page/9/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green and dark blue. Below the text "ERT" is the tagline "Confidence at every turn".
15 Performance Data - Summary of Device Testing
Performance Testing
The following standards and practices were followed for development of the Asthma Monitor AM3 G+ and accessory software AMOS:
- . The device was developed and tested according to GMP Standard Operating Procedures for Medical Devices.
- . Software verification and validation was done in accordance with IEC 62304:2006 + A1:2015.
- . Risk analysis was performed according to ISO 14971:2007.
- Tests were performed to confirm that the Asthma Monitor meets the ● recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS 2005 standards.
- . The electrical safety testing was performed according to IEC 60601-1:2012 and IEC 60601-1-11:2015 to demonstrate conformance with the requirements for basic safety and essential performance.
- . The Electro Magnetic Compatibility testing was performed according to IEC 60601-1-2:2014.
- . The FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" issued on August 14, 2013 was considered for the 3G/BT functions and all requirements are fulfilled.
- . BT and 3G functions of the Asthma Monitor AM3 G+ were tested according to the Federal Communications Commission's rules and regulation in Title 47 of the Code of Federal Regulations to demonstrate conformity with defined frequency bands and frequencies for the different spectrum allocations.
- . The FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" from 2014 has been considered in the device design and all requirements are fulfilled.
The verification and validation activities for hardware and software were performed and the results demonstrated that the predetermined acceptance criteria were met.
Biocompatibility
There have been no changes in material and biocompatibility. All material used is identical to the predicate device. The manufacturing process is identical to the predicate device.
10
Image /page/10/Picture/1 description: The image contains the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.
The Rotary Flow Sensor is exactly the same as already used in the predicate device and among all Asthma Monitor devices.
No new biocompatibility testing was done, as the biocompatibility testing for the predicate device remains effective for this submission.
Clinical Testing No clinical testing is required.
Compliance with FDA-recognized Standards:
| Standard | Description |
|---|---|
| IEC 60601-1:2012 | Electrical Safety of Medical Devices |
| IEC 60601-1-2:2014 | Electromagnetic Compatibility of Medical Devices |
| IEC 60601-1-11:2015 | Electrical Safety of Medical Devices in the home |
| healthcare environment | |
| ISO 14971:2007 | Risk Management |
| ISO 10993-1:2009 | Biological evaluation of Medical Devices |
| IEC 62304:2006 + A1:2015 | Medical Device Software - Software life-cycle processes |
Conclusion 16
The modified device, AM3 G+ shares the same intended use but has different technological characteristics. Based on the intended use and the results of the performance testing provided in the 510(k), the device is found to be substantially equivalent to the predicate device AM3 GSM (K133722).