(194 days)
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 to test pulmonary function and obtain spirometric indices for
- adult and pediatric patients 12 years and older,
- hospital and clinic use only.
Medikro® spirometer runs on a personal computer with Microsoft Windows operating systems.
Medikro@ spirometer unit is connected to PC via USB port (USB model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. Nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations.
Medikro® 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 port, so no other external or internal power supply is needed.
The Medikro® Spirometer (M913 Medikro® Nano, M914 Medikro® Primo, M915 Medikro® Pro) is designed to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. The devices were tested to ensure they meet the essential performance criteria for spirometers as defined by the American Thoracic Society (ATS) and ISO 26782 standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ATS/ERS & ISO 26782 Standards) | Reported Device Performance (Medikro® Spirometers) |
|---|---|
| ATS/ERS Standards (Eur Respir J, 2005, Vol 26, pp. 948-968): | All units meet the recommendations for: |
| Measuring FVC | Met |
| Measuring FEV1 | Met |
| Measuring FEF25-75% | Met |
| Measuring PEF | Met |
| Measuring MVV | Met |
| Resistance to flow | Met |
| ISO 26782:2009 Standards: | All units meet the ISO 26782 requirements for: |
| Measuring FVC accuracy and repeatability | Met |
| Measuring FEV1 accuracy and repeatability | Met |
| Measuring FEV6 accuracy and repeatability | Met |
| Linearity | Met |
| Impedance | Met |
| Safety and EMC Standards: | |
| AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | Complied |
| IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complied |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size in terms of number of human subjects or unique cases for the performance testing. Instead, the testing involved exposing all three device models (M913 Medikro® Nano, M914 Medikro® Primo, and M915 Medikro® Pro) to standardized conditions using "24 standard waveforms" as specified by the American Thoracic Society (ATS) and further tests as per ISO 26782.
The data provenance is not explicitly stated as "country of origin" for the ATS/ERS and ISO 26782 standard waveforms. These are international standards, implying a general applicability rather than specific regional data. The testing itself was performed at CSA Group CB testing laboratory and Savonia Polytechnic EMC laboratory, both located in Finland, which is the manufacturer's country of origin. The study appears to be prospective in nature, as it involved physical testing of the manufactured devices against predefined international standards.
3. Number, Qualifications, and Adjudication Method of Experts
This study did not involve human experts to establish ground truth for clinical performance in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" or reference for the device's performance was established by adherence to universally accepted engineering and medical device standards for spirometry.
- Experts: Not applicable for establishing ground truth of the test set in this context. The "experts" in this scenario would be the bodies that define the ATS/ERS and ISO standards, which are internationally recognized professional organizations in respiratory medicine and standardization.
- Qualifications: Not applicable.
- Adjudication method: Not applicable.
4. Adjudication Method (for the test set)
Not applicable. The performance was assessed against objective, predefined values and ranges specified by the ATS/ERS and ISO 26782 standards. There was no expert adjudication process in this technical validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a diagnostic spirometer, not an AI-assisted diagnostic tool for interpretation of human expert readings. The study focuses on the technical performance of the device in accurately measuring lung parameters, not on how human readers' interpretations improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The performance of the Medikro® spirometers was evaluated in isolation (algorithm only, as they calculate measurements based on raw data) against established international standards (ATS/ERS and ISO 26782) without human intervention in the measurement process. The device's ability to accurately measure FVC, FEV1, FEF25-75%, PEF, MVV, and FEV6, as well as its linearity and impedance characteristics, were tested directly against these benchmarks.
7. Type of Ground Truth Used
The ground truth used was based on internationally recognized performance standards and simulated waveforms. Specifically:
- Standardized Waveforms: The "24 standard waveforms" from the American Thoracic Society (ATS) served as the reference for dynamic performance.
- Engineering Specifications: The ISO 26782 standard provides precise numerical acceptance criteria for accuracy, repeatability, linearity, and impedance.
- Safety and EMC Standards: AAMI / ANSI ES 60601-1 and IEC 60601-1-2 define the ground truth for electrical safety and electromagnetic compatibility.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI algorithms. The device performs calculations based on established physiological formulas and measurement principles, not through a learned model from a training dataset. Therefore, this question is not applicable to the described device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning. The device's operation relies on known physics and physiological models, not on a data-trained algorithm.
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MAY 2 1 2014
| DATE | May 21, 2014 | |
|---|---|---|
| General Information | ||
| Trade Names: | M913 Medikro® Nano, M914 Medikro® Primo and M915Medikro® Pro | |
| Common Name: | Spirometer, Diagnostic Spirometer | |
| Classification Name: | Spirometer, Diagnostic Spirometer (21 CFR 868.1840, Produ-Code BZG) | |
| Classification: | Class II | |
| Manufacturer: | Medikro OyKellolahdentie 27FI-70460 KuopioFinlandtel: +358 17 283 3000 | |
| Corresponding Official: | Mikko Eloranta, Managing Directortel: +358 17 283 3000fax: +358 17 283 3300 | |
| Predicate Devices: | Caird Technology Spirometer, K971336Welch Allyn CardioPerfect Workstation, Software Version1.5.0, K052158 |
510(k) Summary
Device Description
ﺮ ﻓﻲ ﺍﻟﻤﺮﺍﺟﻊ
Medikro® spirometer runs on a personal computer with Microsoft Windows operating systems.
Medikro@ spirometer unit is connected to PC via USB port (USB model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. Nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations.
Medikro® 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
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based on the results and patient information. For details about tested reference values see: Tab Software Verification and Validation.
The spirometers take all the power that it needs from the USB port, so no other external or internal power supply is needed.
Image /page/1/Picture/2 description: The image shows a white medical device with a USB connector on one end and a cylindrical sensor on the other. A white cable connects the two ends, forming a loop in the center. The device is placed on a dark surface, and the number "1" is visible in the upper right corner of the image. The device appears to be a medical sensor used for data collection.
Figure 1: M913, Medikro® Nano spirometer with Pressure Tube and Disposable Flow Transducer
Image /page/1/Picture/4 description: The image shows a medical device with the word "MEDIKRO" printed on it. The device consists of a rectangular box connected to a tube, which is connected to a cylindrical object. The number 2 is in the upper right corner of the image. The device is white and is on a dark background.
Figure 2: M914, Medikro® Primo spirometer with Pressure Tube and Disposable Flow Transducer
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Image /page/2/Picture/0 description: The image shows a medical device with a white rectangular box labeled "MEDIKRO pro". A white cable extends from the box and forms a loop before connecting to a T-shaped connector. The number 3 is in the upper right corner of the image.
Figure 3: M915, Medikro® Pro spirometer with Pressure Tube and Disposable Flow Transducer
Indications For Use:
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 to test pulmonary function and obtain spirometric indices for
- . adult and pediatric patients 12 years and older,
- . hospital and clinic use only.
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Key Technological Characteristics
| Feature | Predicate Device510(K) NumberK971336 | Predicate Device510(K) NumberK052158 | New devicesM913 Medikro® Nano,M914 Medikro® PrimoM915 Medikro® Pro |
|---|---|---|---|
| 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 |
| Includesinterpretationsoftware | Yes | Yes | Yes |
| Results downloadto clinical software | Yes | Yes | Yes |
| Patient resultstorage capacity | Depending thesize of the datastorage media | Depending the size ofthe data storagemedia | Depending the sizeof 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 MicroUSB connection |
| ATS compatible | Yes | Yes | Yes |
| Flow Transducer | Disposable | Disposable | Disposable |
| Flow TransducerMaterial | HDPE | HDPE | HDPE |
| ExxonMobil | ExxonMobil | ExxonMobil | |
| HDPE HMA | HDPE HMA | HDPE HMA | |
| 016 | 016 | 016 | |
| Pressure TubeMaterial | TPU (Estane® | TPU (Estane® | TPU (Estane® |
| 58277) and White | 58277) and White | 58277) and White | |
| nylon | nylon | nylon | |
| resin (Zytel 101F) | resin (Zytel 101F) | resin (Zytel 101F) | |
| Size ( H x W x L)m minch | Serial model16 x 34 x 530.63 x 1.34 x 2.09 | Serial model16 x 34 x 530.63 x 1.34 x 2.09USB model17 x 36 x 790.67 x 1.42 x 3.11 | Nano14 x 26 x 560.55 x 1.02 x 2.20Primo13 x 30 x 1070.51 x 1.18 x 4.21Pro13 x 30 x 1070.51 x 1.18 x 4.21 |
| WeightGramsOunces | Serial22 g0.77 oz | Serial model22 g0.77 ozUSB20 g0.70 oz | Nano11g0.39 ozPrimo305g10.76 ozPro305g10.76 oz |
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The new devices have the same intended use and characteristics as the predicate devices.
The new devices have the same intended use, fundamental scientific technology and operating principle as the predicate. Differences between the subject device and the predicates include: the mechanical design of the flow transducers and calculation algorithms for flow.
Nonclinical tests
Following tests were made to the devices:
- AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
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- 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'')
- ISO 26782:2009. Anaesthetic and respiratory equipment Spirometers intended for . the measurement of time forced expired volumes in humans.
Conclusion for Nonclinical tests
Medikro spirometers M913 Medikro® Nano, M914 Medikro@ Primo and M915 Medikro® Pro are all tested according AAMI / ANSI ES 60601-1:2005 standard. Testing was performed at CSA group CB testing laboratory. Based on test results Medikro spirometers M913 Medikro® Nano, M914 Medikro® Primo and M915 Medikro® Pro were found to comply with AAMI / ANSI ES 60601-1:2005 standard.
IEC 60601-1-2 EMC testing was made to M915 Medikro® Pro, M913 Medikro® Nano and M911 Medikro® Ambi. EMC testing was made according to IEC 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 M915 Medikro® Pro, M913 Medikro® Nano and M911 Medikro® Ambi. Difference between M915 Medikro@ Pro and M914 Medikro@ Primo is the external casing and that Primo does not measure ambient conditions (same circuit board, but these components are left out).
American Thoracic Society (ATS) 24 standard waveforms test was made for all spirometer units (M915 Medikro® Pro, M914 Medikro® Primo and M913 Medikro® Nano) and all units meet the recommendations for:
- . Measuring FVC
- Measuring FEVI .
- . Measuring FEF25-75%
- Measuring PEF .
- . Measuring MVV
- Resistance to flow .
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.
ISO 26782 test was made for all spirometer units (M915 Medikro® Pro, M914 Medikro® Primo and M913 Medikro® Nano) and all units meet the ISO 26782 requirements for:
- Measuring FVC accuracy and repeatability .
- Measuring FEV 1 accuracy and repeatability .
- � Measuring FEV6 accuracy and repeatability
- Linearity .
- lmpedance .
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Testing was done for the Medikro Oy measuring devices Medikro Spirometer models Nano, Primo and Pro against recommendations published in the ISO 26782 standard.
Based on these results Medikro spirometers M913 Medikro® Nano, M914 Medikro® Primo and M915 Medikro® Pro are substantially equivalent to the predicate devices. Any differences between the subject and predicate devices do not raise any new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WORK-G609 Silver Spring, MD 20993-0002
Public Health Service
May 21, 2014
Medikro Oy Mr. Mikko Eloranta Managing Director P.O. Box 54 FI-70101 Kuopio Finland
Re: K133428
Trade/Device Name: M913 Medikro Nano, M914 Medikro Primo and M915 Medikro® Pro Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG Dated: March 21, 2014 Received: March 24, 2014
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
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Page 2- Mr. Mikko Eloranta
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 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 devicerelated 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" (21 CFR 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,
Tejashri Purobit-Sheth, M.D.
Tejashri Purohit Sheth, MD, Clinical Deputy Director
DAGRID/ODE/CDRI FOR
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
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Indications for Use M913 Medikro® Nano, M914 Medikro® Primo and M915 Medikro® Pro
| 510(k) Number: | 133428 |
|---|---|
| Device Names: | M913 Medikro® Nano, M914 Medikro® Primo and M915 Medikro®Pro |
Indications For Use:
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 to test pulmonary function and obtain spirometric indices for
- adult and pediatric patients 12 years and older, .
- . hospital and clinic use only.
Prescription Use _ X (Per 21 CFR 801.109) OR
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)
Anya C. Harry -S 2014.05.21 09:29:17 -04'00'
§ 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).