Medikro Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values.

The device is designed for

. adult and pediatric patients,
hospital and clinic use only.

Device Description

Medikro® SpiroStar spirometer runs on a personal computer with Microsoft Windows operating systems.

Medikro® SpiroStar spirometer unit is connected to PC via USB port (USB model) or via serial port (DX model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. A nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations.

Medikro® SpiroStar spirometers are used to measure lung air volume and airflow rate. Medikro® Spirometry Software is used to perform the measurement and calculate the measurement volume based on chosen reference value. The reference value is based on patient's gender, race and age. User can analyze the results in different presentations and create a final report based on the results and patient information.

The spirometers take all the power that it needs from the USB or serial port, so no other external or internal power supply is needed.

AI/ML Overview

The Medikro® SpiroStar device, including models M929 (USB) and M921 (DX), is a diagnostic spirometer intended to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. The device's performance was evaluated against the American Thoracic Society (ATS) recommendations for spirometers to demonstrate substantial equivalence to predicate devices.

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

Performance Criteria (ATS Recommendations)	Acceptance Criteria for Spirometers (ATS)	Reported Device Performance (Medikro® SpiroStar USB & DX)
Measuring FVC	Meets ATS recommendations	Meets ATS recommendations
Measuring FEV1	Meets ATS recommendations	Meets ATS recommendations
Measuring FEF25-75%	Meets ATS recommendations	Meets ATS recommendations
Measuring PEF	Meets ATS recommendations	Meets ATS recommendations
Resistance to flow	Meets ATS recommendations	Meets ATS recommendations
Testing under BTPS conditions	Meets ATS recommendations	Meets ATS recommendations

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

The document does not explicitly state the sample size for the test set in terms of number of patients or spirometry maneuvers. Instead, it refers to "American Thoracic Society (ATS) 24 standard waveforms test". This suggests the use of a standardized set of simulated waveforms rather than patient data. The provenance of these standard waveforms is the American Thoracic Society. It is a retrospective evaluation against established synthetic data.

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)

The ground truth for this study was established by the "American Thoracic Society (ATS) 24 standard waveforms". These are not "expert-generated ground truth" in the typical sense of a clinical interpretation, but rather predefined, standardized synthetic waveforms with known, precise values for spirometry parameters. Therefore, no human experts were involved in establishing the "ground truth" for the test set in this context.

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

Not applicable. The test involved comparing the device's measurements against the known values of the ATS 24 standard waveforms. This is a direct measurement comparison, not an expert-based adjudication process.

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 is a performance study for a diagnostic spirometer, which directly measures physiological parameters. It is not an AI-based interpretation system, and therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Yes, a standalone performance evaluation was conducted. The Medikro® SpiroStar units (USB and DX) were tested directly against the ATS 24 standard waveforms to determine if their measurements met the specified recommendations. This is an algorithm-only (device-only) performance assessment.

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

The type of ground truth used was standardized synthetic waveforms with known, precise values, specifically the American Thoracic Society (ATS) 24 standard waveforms.

8. The sample size for the training set

The document does not mention a training set. This type of device (diagnostic spirometer) typically relies on engineering and physiological principles for its design and calibration, rather than machine learning models that require training data. The testing described is a validation of the device's accuracy against established standards.

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

Not applicable, as no training set or machine learning components are described in the context of this device's performance evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 24, 2015

Medikro Oy Mr. Mikko Eloranta Managing Director Kellolahdentie 27 FI-70460 Kuopio Finland

Re: K120577

Trade/Device Name: Medikro SpiroStar USB and Medikro SpiroStar DX Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: June 15, 2015 Received: June 18, 2015

Dear Mr. Eloranta:

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.

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Page 2 - Mr. Eloranta

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:	K120577
Device Name:	Medikro® SpiroStar
Models:	M929, Medikro SpiroStar USB and M921, Medikro SpiroStar DX

Indications For Use:

The device is designed for

. adult and pediatric patients,
hospital and clinic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _ _ _ _ _ _ _ _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

General Information

Date:	24.6.2015
Trade Names:	M929, Medikro SpiroStar USB andM921, Medikro SpiroStar DX
Common Name:	Diagnostic Spirometer
Classification Name:	Spirometer, Diagnostic
Classification:	Class II
Manufacturer:	Medikro OyPioneerinkatu 3FI-70800 KuopioFinlandtel: +358 17 283 3000
Corresponding Official:	Mikko Eloranta, Managing Directortel: +358 17 283 3000fax: +358 17 283 3300
Predicate Devices:	Caird Technology Spirometer, K971336
	Welch Allyn CardioPerfect Workstation, Software Version1.5.0, K052158

Device Description

Medikro® SpiroStar spirometer runs on a personal computer with Microsoft Windows operating systems.

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The spirometers take all the power that it needs from the USB or serial port, so no other external or internal power supply is needed.

Indications for Use

The device is designed for

. adult and pediatric patients,
. hospital and clinic use only.

Nonclinical tests

Following tests were made to the devices:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for ● Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). (General)
IEC 60601-1-4:2000 Consol. Ed. 1.1. Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
American Thoracic Society and European Respiratory Society (Eur Respir J, 2005, ● Vol 26, pp. 948-968. No. 5 in SERIES "ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING'')

Conclusion for Nonclinical tests

Complete IEC 60601-1 testing was carried out for the equipment. Full test reports were made for both M929 Medikro® SpiroStar USB and M921 Medikro® SpiroStar DX (Serial). The equipment was found to comply with standard requirements.

IEC 60601-1-2 EMC testing was made for both sensor units (USB and DX). EMC testing was made according to IEC/EN 60601-1-2 requirements and includes both emissions and immunity testing. Testing was performed at Savonia Polytechnic EMC laboratory by the laboratory test engineer. Full test reports were made for both M929, Medikro® SpiroStar USB and M921, Medikro® SpiroStar DX (Serial).

IEC 60601-1-4 testing was made and the equipment was found to comply with standard requirements.

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American Thoracic Society (ATS) 24 standard waveforms test was made for both units (USB and DX) and both units meet the recommendations for:

. Measuring FVC
Measuring FEV1
Measuring FEF25-75% ●
. Measuring PEF
Resistance to flow
Testing under BTPS conditions .

Testing was done for the Medikro Oy measurement devices against recommendations published by the American Thoracic Society. The essential performance criteria's for spirometers is well defined by the ATS. Spirometers meeting ATS criteria for essential performance are substantially equal. The predicate devices are also designed to meet these ATS criteria.

Feature	Predicate Device510(K) Number	Predicate Device510(K) Number	New Device
	K971336	K052158	Medikro® SpiroStar
Deviceclassification	Spirometer,diagnostics	Spirometer,diagnostics	Spirometer,diagnostics
Target population	Adult andpediatric patients	Adult and pediatricpatients	Adult and pediatricpatients
Use environment	Hospital/Clinical	Hospital/Clinical	Hospital/Clinical
Indices measured	FEV1, FVC,FEV1/FVC,PEF, FEF25-75%+others	FEV1, FVC,FEV1/FVC,PEF, FEF25-75%+others	FEV1, FVC,FEV1/FVC, PEF,FEF25-75% +others
Real-time display ofeach blow	Yes	Yes	Yes
Feedback about testquality	Yes	Yes	Yes
Flow-volumedisplayed & printed	Yes	Yes	Yes
Volume-timeprinted	Yes	Yes	Yes
Quantifies postbronchodilatorchange	Yes	Yes	Yes
Prints predictedflow-volume curve	Yes	Yes	Yes

Key Technological Characteristics

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Feature	Predicate Device	Predicate Device	New Device
	510(K) NumberK971336	510(K) NumberK052158	Medikro® SpiroStar
Includesinterpretationsoftware	Yes	Yes	Yes
Results downloadto clinical software	Yes	Yes	Yes
Patient resultstorage capacity	Depending the size of the datastorage media	Depending the size of the data storagemedia	Depending the size of the data storagemedia
Portable/notportable	Portable withlaptop PC	Portable with laptopPC	Portable with mobilePC
Power source andconnection to PC	PC Serialconnection	PC USB or Serialconnection	PC USB or Serialconnection
ATS compatible	Yes	Yes	Yes
Flow Transducer	Disposable	Disposable	Disposable

The New Device has the same intended use and safety characteristics as the predicate devices.

Conclusion

Based on completed performance testing our device demonstrates that it is substantially equivalent to the predicate device.

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).