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.

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.

AI/ML Overview

The provided text describes the Asthma Monitor AM3 G+ device and its substantial equivalence determination by the FDA. However, it does not contain detailed information regarding the acceptance criteria for a specific study that proves the device meets those criteria, especially in the context of an AI/ML-driven device with complex performance metrics often seen in such submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Asthma Monitor AM3 GSM K133722) by highlighting similar intended use and comparable technological characteristics, as well as adherence to various performance, safety, and regulatory standards.

Here's an analysis of the requested information based only on the provided text:

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

The document mentions accuracy and precision for spirometry according to ATS/ERS 2005 standards. It lists the following performance parameters for both the predicate and the subject device:

Acceptance Criteria (ATS/ERS 2005 standards)	Reported Device Performance (Asthma Monitor AM3 G+)
PEF: $\pm$ 5% or $\pm$ 20 l/min	PEF: $\pm$ 5% or $\pm$ 20 l/min
FEV1: $\pm$ 3% or $\pm$ 0.05 liter	FEV1: $\pm$ 3% or $\pm$ 0.05 liter

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

The document states: "No clinical testing is required." and refers to "Performance Testing" which seems to be laboratory-based verification and validation. Therefore, a "test set" in the context of clinical data or patient samples is not explicitly mentioned as being used for this submission. The data provenance is not specified beyond the fact that the company is located in Germany.

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)

This information is not provided in the document. As no clinical testing was required, there's no mention of experts establishing ground truth for a clinical test set.

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

This information is not provided because no clinical test set requiring adjudication 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

This information is not provided. The device described is a diagnostic spirometer with a symptom diary, not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved performance. The "clinical staff" mentioned in the description of AMOS software are professional users, but their interaction with an AI component for diagnostic improvement is not discussed.

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

The device itself is a standalone electronic measurement device. The performance data provided (PEF and FEV1 accuracy) represents the algorithm's (or device's) standalone measurement capabilities. The AMOS software processes and displays data but does not provide diagnosis or treatment suggestions; these are made by the physician.

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

For the accuracy and precision measurements (PEF and FEV1), the ground truth would typically be established by highly accurate reference spirometry equipment or calibrated flow/volume simulators, adhering to standards like ATS/ERS. However, the document does not explicitly detail the method for establishing this "ground truth" for the performance tests, beyond stating adherence to ATS/ERS standards.

8. The sample size for the training set

This information is not applicable and not provided. The Asthma Monitor AM3 G+ is a traditional medical device (spirometer) and not explicitly described as an AI/ML device that requires a training set in the conventional sense. The "training" of the device likely refers to its calibration and validation against established standards.

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

This information is not applicable and not provided, as the device is not described as an AI/ML product requiring a "training set" with established ground truth in the AI context.

Summary

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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

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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

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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 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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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 SubmissionSpecial 510(k) SubmissionDate 510(k) summary prepared: 10/03/2019
2	Submitter
	Name: eResearchTechnology GmbH
	Address: Sieboldstrasse3D-97230 EstenfeldGermany
	Contact person in Germany:(Official Correspondent) Kristin Feld
	Address: eResearchTechnology GmbHSieboldstrasse 3, 97230 EstenfeldGermany
	Phone: +49 9305 720 6377FAX: +49 9305 720 60E-mail kristin.feld@ert.com
	Contact person in the U.S.: Mingzi Deng
	Address eResearch Technology500 Rutherford AvenueBoston, 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+

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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)

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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]).

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 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)

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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.

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 MonitorAM3GSM(K133722)	Asthma MonitorAM3 G+
Indicationsfor Use	The Asthma Monitor AM3 is anelectronic measurement deviceto monitor the lung function(determination of the respiratoryflows and volume) with highreproducibility wherever andwhenever there is a need of.The AM3 measures the flowduring expiration serving for thecalculation of furtherparameters as FEV1.The AM3 is used to monitor therespiratory status of adulthuman beings in the areas ofasthma, chronic obstructivepulmonary disorder and inareas like occupationalmedicine, clinical trials anddisease management.The patient is informed of the	The Asthma Monitor AM3G+ isan electronic measurementdevice to monitor the lungfunction (determination of therespiratory flows and volume)with high reproducibility whereverand whenever there is a need of.The AM3 measures the flowduring expiration serving for thecalculation of further parametersas FEV1.The AM3 is used to monitor therespiratory status of humanbeings (adults and children 5years and older) in the areas ofasthma, chronic obstructivepulmonary disorder and in areaslike occupational medicine,clinical trials and diseasemanagement.
	results by numeric values forthe selected parameters (e.g.PEF, FEV1). Furthermore, avisual control unit, displayed inthe form of traffic lights, allowsan immediate 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. Inaddition, questionnairefunctionality can be called up bythe use of a software package(AMOS) to record e.g. the"Quality of Life" status.When enabled, the AM3 can beprogrammed with a couple ofquestions, where the patientcan then select from a couple ofdifferent answers. Thisinformation is also stored in theinternal database and can betransmitted for evaluation to astandard PC using the softwarepackage AMOS.The AM3 is designed to replacean ordinary peak flow meter,diary and pencil by a singlesystem. Easy handling, sturdyand handy design allow theAsthma Monitor AM3 to be usedin healthcare, clinical and homeuse environments/settings.	The patient is informed of theresults by numeric values for theselected parameters (e.g. PEF,FEV1). Furthermore, a visualcontrol unit, displayed in the formof traffic lights, allows animmediate indication of themeasurement based on criteriadefined by the patient'sphysician.The device saves the results of ameasurement (always with dateand time) automatically in aninternal database. In addition,(symptom and medications)questionnaire functionality can becalled up by the use of a software(AMOS) to record e.g. the"Quality of Life" status.When enabled, the AM3 can beprogrammed with a couple ofquestions, where the patient canthen select from a couple ofdifferent answers. Thisinformation is also stored in theinternal database and can betransmitted for evaluation usingthe software AMOS.The AM3 is designed to replacean ordinary peak flow meter,diary and pencil by a singlesystem. The asthma monitor AM3is intended to be used in healthcare, clinical and home useenvironments.
Patientpopulation	The Asthma Monitor can beused for patients from 4 yearson and older.	The Asthma Monitor can beused for patients from 5 yearson and older.
Measurementprinciple	Determination of respiratoryflow and volume viaexchangeableinfrared rotary flow sensor	Identical
Dimensions(housing)	Length x Width x Height:112 x 82 x 37 mmWeight:150 g (batteries included)	Identical
Display	LCD moduleSize: 54.0 x 33.5 mm255 x 160 dots	TFT LCD moduleSize: 57.6 x 43.2 mm320 x 240 dots
	Foil Key-panel (4 keys):	identical
Key-panel	- ESC (on/off)- UP-ARROW- DOWN-ARROW- OK
Integratedmouthpiece(material)	Styrolution PS 454N, singlepatient use	identical
Housing ofthe device(material)	Cycoloy HC 1204HF, ROTECABS 1001 FR	identical
Performance(measurements)	Parameters:PEFFEV1Accuracy:PEF: $\pm$ 5% or $\pm$ 20 l/minFEV1: $\pm$ 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
OperatingRequire-ments	PC software AMOSFor standard PC withWindows OS	AMOS AppMobile application for AndroidOS higher 6.x and Windows 10
Bluetoothinterface	WML-C46 (Mitsumi)	BT121 (Silicon Lab)
Mobilecommunication Interface	Sierra WirelessWISMO288	Sierra WirelessAirPrime HL8548
Expectedoperationallifetime	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".

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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).

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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.

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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 homehealthcare 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).

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).