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.

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)

AI/ML Overview

The provided text describes a Special 510(k) submission for a device called the Asthma Monitor AM3 GSM, which is a modification of an existing device (Asthma Monitor AM3/AM3 BT, K092890). The key modification is the addition of GSM functionality for data transfer and a Li-Ion battery.

The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness, rather than demonstrating that the device meets specific performance acceptance criteria for diagnostic accuracy through a clinical study.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth, expert opinions, and comparative effectiveness studies is not directly available or applicable in the provided text in the context of typical AI/diagnostic device clinical study reporting. The submission is primarily about demonstrating the safety and effectiveness of a feature addition (GSM data transfer and a new battery type) to an already cleared device, not a new diagnosis or interpretation algorithm.

Here's a breakdown of the specific points based on the available text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies the acceptance criteria are related to maintaining the performance (accuracy of flow and volume measurements) and safety standards of the predicate device, while demonstrating the safe and effective integration of the new features (GSM data transfer and Li-Ion battery). Specific quantitative performance criteria for the diagnostic function (e.g., sensitivity, specificity for a diagnostic claim) are not explicitly stated as this is a device modification submission for a spirometer, not a new diagnostic algorithm.
- The predicate device's performance regarding "Accuracy Flow: ± 5% or ± 20 1/min" and "Accuracy Volume: ± 3% or ± 0.05 liter" could be considered the baseline performance that the modified device is expected to maintain, but it's not explicitly stated as an "acceptance criterion" for this specific submission's new features.
Reported Device Performance: The document states:
- "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."
- "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."
- "The Li-Ion battery and the power supply fulfil the common standards and were implemented and tested for safe and effective use."
- "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."

Summary Table of (Relevant) "Acceptance Criteria" and Reported Performance (Inferred from the text):

Acceptance Criteria (Inferred from Text)	Reported Device Performance (From Text)
Device performance (measurement accuracy) should not be affected by new GSM function.	"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."
Integrity of transferred data, latency, and throughput requirements for wireless transfer must be met.	"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."
Li-Ion battery and power supply must meet common safety and effectiveness standards.	"The Li-Ion battery and the power supply fulfil the common standards and were implemented and tested for safe and effective use."
Conformity to relevant standards (EMC, telecommunications, software development, risk analysis, safety).	"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." "The risk analysis method used to assess the impact... was a Failure Modes and Effects Analysis (FMEA)." "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards." "Applied EMC and telecommunications standards and regulations... are fulfilled."
No new questions of safety and effectiveness compared to predicate device.	"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."

The following points (2-9) are largely not applicable or not detailed in this specific type of 510(k) submission, as it focuses on demonstrating substantial equivalence for a device modification (adding connectivity and a new battery), not on a new diagnostic algorithm's performance against a ground truth in a clinical study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified/Applicable: The document does not describe a test set or data provenance for a diagnostic performance study. The testing described is primarily engineering and software verification/validation (EMC testing, GSM module testing, software development, safety test procedures).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable: No ground truth establishment for a test set is discussed, as this is not a diagnostic accuracy study for a new algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable: No test set or adjudication method for diagnostic results is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable: This device is a spirometer for measuring lung function and assisting in monitoring, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable: The device is a measurement device (spirometer), not an AI algorithm. Its performance is inherent in its physical measurement capabilities. The "algorithm" mentioned refers to the software controlling the device and its data handling, not a diagnostic interpretation algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable: No diagnostic ground truth is discussed. The device measures physical parameters (PEF, FEV1). The "ground truth" for its accuracy would relate to comparisons against calibrated reference standards for flow and volume.

8. The sample size for the training set

Not applicable: There is no mention of a training set, as this is not an AI/machine learning submission.

9. How the ground truth for the training set was established

Not applicable: No training set or ground truth establishment for it is discussed.

Summary

{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:

E-mail

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.

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 MonitorAM3/AM3 BT(K092890)	Asthma MonitorAM3 GSM
Indicationsfor Use	The Asthma Monitor AM3 / AM3 BT from Cardinal Health is anelectronic measurement deviceto monitor the lung function	The Asthma Monitor AM3/AM3/AM3 GSM is an electronicmeasurement device to monitorthe lung function (determination
(determination of the respiratoryflows and volume) with highreproducibility wherever andwhenever is a need of. TheAM3 / AM3 BT measures theflow during expiration servingfor the calculation of furtherparameters as FEV1.	of the respiratory flows andvolume) with high reproducibilitywherever and whenever is aneed of. The AM3 measures theflow during expiration serving farthe calculation of furtherparameters as FEV1.
The AM3 / AM3 BT is used tomonitor the respiratory status ofhuman beings in the areasasthma, chronic obstructivepulmonary disorder and inareas like occupationalmedicine, clinical trials anddisease management.	The AM3 is used to monitor therespiratory status of human adultbeings in the areas asthma,chronic obstructive pulmonarydisorder and in areas likeoccupational medicine, clinicaltrials and disease management.
The patient is informed of theresults by numeric values forselected parameters (e.g. PEF,FEV1). Furthermore a visualcontrol unit, displayed as a kindof traffic lights, allows animmediate indication of themeasurement based on criteriadefined by the patient'sphysician.	The patient is informed of theresults by numeric values forselected parameters (e.g. PEF,FEV1). Furthermore a visualcontrol unit, displayed as a kindof traffic lights, allows animmediate indication of themeasurement based on criteriadefined by the patient'sphysician.
The device saves the results ofa measurement (always withdate and time) automatically inan internal database.The memory capacity isdesigned to store up to 400measurements.In addition, a questionnairefunctionality can be called up bythe use of a software package(AMOS) to record e.g. the"Quality of Life" status. Whenenabled, the AM3 / AM3 BT canbe programmed with a couple ofquestions, where the patientcan select then from a couple ofdifferent answers	designed to store up to 400measurements.In addition, a questionnairefunctionality can be called up bythe use of a software package(AMOS) to record e.g. the"Quality of Life" status. Whenenabled, the AM3 / AM3 BT canbe programmed with a couple ofquestions, where the patientcan select then from a couple ofdifferent answers.This information is also storedin the internal database and canbe transmitted for evaluation toa standard PC using thesoftware package AMOS.The AM3 / AM3 BT is designedto replace ordinary peak flowmeter, diary and pencil by asingle system. Easy handling,sturdy and handy design allowthe AM3 / AM3 BT being usedalmost everywhere: at work, athome, in school, for expertsopinion, research or clinical trialpurposes and in occupationalmedicine.	The device saves the results of ameasurement (always with dateand time) automatically in aninternal database.In addition, a questionnairefunctionality can be called up bythe use of a software package(AMOS) to record e.g. the"Quality of Life" status. Whenenabled, the AM3 can beprogrammed with a couple ofquestions, where the patient canselect then from a couple of	internal database.In addition, a questionnairefunctionality can be called up bythe use of a software package(AMOS) to record e.g. the"Quality of Life" status. Whenenabled, the AM3 can beprogrammed with a couple ofquestions, where the patient canselect then from a couple ofdifferent answers.This information is also stored inthe internal database and can betransmitted for evaluation to astandard PC using the softwarepackage AMOS.The AM3 is designed to replaceordinary peak flow meter, diaryand pencil by a single system.Easy handling, sturdy and handydesign allow the Asthma MonitorAM3 being used in healthcare,clinical and home useenvironments/settings, for expertopinion, research or clinical trialpurposes and in occupationalmedicine.
		> Besides minor wordingchanges the Intended Use isidentical to K092890 (see italictext in Intended Use of toK092890)
Patientpopulation	The Asthma Monitor can beused for patients from 4 yearson 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 moduleSize: 54,0 x 33,5 mm255 x 160 dots	Identical
	Foil Key-panel (4 keys):
Key-panel	- ESC (on/off)- UP-ARROW- DOWN-ARROW- OK	identical
Integratedmouthpiece(material)	Polysterol 454C	identical
Single Usemouthpiece(material)	Bormed RG835 MO	identical
	Parameters:
Performance(measurements)	PEFFEV1	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
OperatingRequire-ments	PC software AMOS	identical
Bluetooth	WML-C46 (Mitsumi)	identical

interface
GSMInterface	none	Sierra WirelessWISMO288

{3}------------------------------------------------

5 510(k) Summary

{4}------------------------------------------------

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 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.

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'

Page 1 of

Regulation Number and Section

§ 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).