(1213 days)
Not Found
No
The summary describes a standard spirometer device and software for measuring lung function. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The calculations are based on chosen reference values and standard physiological measurements.
No
The device measures lung function for diagnosis and screening and does not provide therapeutic treatment.
Yes
The device is explicitly stated to be for "pulmonary disease diagnosis and screening," indicating its role in identifying or characterizing a medical condition.
No
The device description clearly states that the system includes hardware components such as the spirometer unit, disposable flow transducer, nose clip, and optional calibration syringe, which are connected to a PC. While software is used for measurement and analysis, it is part of a larger hardware-software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medikro Spirometer measures lung air volume and airflow rate directly from the patient's breath. This is a physiological measurement taken in vivo (within the living body), not a test performed on a sample in vitro (in a lab setting).
- Intended Use: The intended use describes measuring lung function for diagnosis and screening, which aligns with a physiological measurement device, not an IVD.
Therefore, the Medikro Spirometer is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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 for
- . adult and pediatric patients,
- hospital and clinic use only.
Product codes
BZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospital and clinic use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and well-being.
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.
1
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
2
Indications for Use
| 510(k) Number: | K120577 |
|---|---|
| Device Name: | Medikro® SpiroStar |
| Models: | M929, Medikro SpiroStar USB and M921, Medikro SpiroStar DX |
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 for
- . adult and pediatric patients,
- hospital and clinic use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
3
510(k) Summary
General Information
| Date: | 24.6.2015 |
|---|---|
| Trade Names: | M929, Medikro SpiroStar USB and |
| M921, Medikro SpiroStar DX | |
| Common Name: | Diagnostic Spirometer |
| Classification Name: | Spirometer, Diagnostic |
| Classification: | Class II |
| Manufacturer: | Medikro Oy |
| Pioneerinkatu 3 | |
| FI-70800 Kuopio | |
| Finland | |
| tel: +358 17 283 3000 | |
| Corresponding Official: | Mikko Eloranta, Managing Director |
| tel: +358 17 283 3000 | |
| fax: +358 17 283 3300 | |
| Predicate Devices: | Caird Technology Spirometer, K971336 |
| Welch Allyn CardioPerfect Workstation, Software Version | |
| 1.5.0, K052158 |
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.
4
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
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.
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.
5
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 Device
510(K) Number | Predicate Device
510(K) Number | New Device |
|---------------------------------------------|------------------------------------------------------|------------------------------------------------------|---------------------------------------------------|
| | K971336 | K052158 | Medikro® SpiroStar |
| Device
classification | Spirometer,
diagnostics | Spirometer,
diagnostics | Spirometer,
diagnostics |
| Target population | Adult and
pediatric patients | Adult and pediatric
patients | Adult and pediatric
patients |
| 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 of
each blow | Yes | Yes | Yes |
| Feedback about test
quality | Yes | Yes | Yes |
| Flow-volume
displayed & printed | Yes | Yes | Yes |
| Volume-time
printed | Yes | Yes | Yes |
| Quantifies post
bronchodilator
change | Yes | Yes | Yes |
| Prints predicted
flow-volume curve | Yes | Yes | Yes |
Key Technological Characteristics
6
| Feature | Predicate Device | Predicate Device | New Device |
|---|---|---|---|
| 510(K) Number | |||
| K971336 | 510(K) Number | ||
| K052158 | Medikro® SpiroStar | ||
| Includes | |||
| interpretation | |||
| software | Yes | Yes | Yes |
| Results download | |||
| to clinical software | Yes | Yes | Yes |
| Patient result | |||
| storage capacity | Depending the size of the data | ||
| storage media | Depending the size of the data storage | ||
| media | Depending the size of the data storage | ||
| media | |||
| Portable/not | |||
| portable | Portable with | ||
| laptop PC | Portable with laptop | ||
| PC | Portable with mobile | ||
| PC | |||
| Power source and | |||
| connection to PC | PC Serial | ||
| connection | PC USB or Serial | ||
| connection | PC USB or Serial | ||
| connection | |||
| 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.