MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO

K133428 · Medikro OY · BZG · May 21, 2014 · Anesthesiology

Device Facts

• Record ID: K133428
• Device Name: MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
• Applicant: Medikro OY
• Product Code: BZG · Anesthesiology
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Diagnostic spirometer system measuring lung air volume and airflow rate; consists of USB-connected spirometer unit, disposable flow transducer, and pressure tube. Operates via PC-based software (Windows OS) to perform measurements, calculate indices (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%), and compare against reference values based on patient demographics. Used in hospitals and clinics by healthcare professionals. Provides real-time flow-volume/volume-time curves, quality feedback, and post-bronchodilator change quantification. Output used by clinicians for pulmonary function assessment and disease screening. Benefits include standardized, accurate pulmonary testing and digital reporting.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI ES 60601-1:2005 and IEC 60601-1-2 EMC standards. Performance validated against ATS/ERS task force recommendations for spirometry (24 standard waveforms) and ISO 26782 requirements for FVC, FEV1, FEV6 accuracy, repeatability, linearity, and impedance. All models met essential performance criteria.

Technological Characteristics

Diagnostic spirometer; USB-powered. Flow transducer: HDPE (ExxonMobil HDPE HMA 016). Pressure tube: TPU (Estane 58277) and nylon (Zytel 101F). Connectivity: USB/Micro USB to PC. Software-based analysis. Portable form factor. Disposable flow transducers. Complies with ISO 26782 and ATS/ERS standards.

Indications for Use

Indicated for pulmonary disease diagnosis and screening in adult and pediatric patients 12 years and older. For hospital and clinic use only.

Regulatory Classification

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.

Predicate Devices

• Caird Technology Spirometer (K971336)
• Welch Allyn CardioPerfect Workstation, Software Version 1.5.0 (K052158)

Reference Devices

• Medikro Ambi (M911)

Submission Summary (Full Text)

{0}------------------------------------------------

K133428

# MAY 2 1 2014

| DATE | May 21, 2014 | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|--|
| General Information | | |
| Trade Names: | M913 Medikro® Nano, M914 Medikro® Primo and M915<br>Medikro® Pro | |
| Common Name: | Spirometer, Diagnostic Spirometer | |
| Classification Name: | Spirometer, Diagnostic Spirometer (21 CFR 868.1840, Produ-<br>Code BZG) | |
| Classification: | Class II | |
| Manufacturer: | Medikro Oy<br>Kellolahdentie 27<br>FI-70460 Kuopio<br>Finland<br>tel: [phone] | |
| Corresponding Official: | Mikko Eloranta, Managing Director<br>tel: [phone]<br>fax: [phone] | |
| Predicate Devices: | Caird Technology Spirometer, K971336<br><br>Welch Allyn CardioPerfect Workstation, Software Version<br>1.5.0, 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

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

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

## Key Technological Characteristics

| Feature | Predicate Device<br>510(K) Number<br>K971336 | Predicate Device<br>510(K) Number<br>K052158 | New devices<br>M913 Medikro® Nano,<br>M914 Medikro® Primo<br>M915 Medikro® Pro |
|---------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>classification | Spirometer,<br>diagnostics | Spirometer,<br>diagnostics | Spirometer,<br>diagnostics |
| Target population | Adult and<br>pediatric patients | Adult and pediatric<br>patients | Adult and pediatric<br>patients |
| Use environment | Hospital/Clinical | Hospital/Clinical | Hospital/Clinical |
| Indices measured | FEV1, FVC,<br>FEV1/FVC,<br>PEF, FEF25-75%<br>+others | FEV1, FVC,<br>FEV1/FVC,<br>PEF, FEF25-75%<br>+others | FEV1, FVC,<br>FEV1/FVC, PEF,<br>FEF25-75% +others |
| Real-time display of<br>each blow | Yes | Yes | Yes |
| Feedback about test<br>quality | Yes | Yes | Yes |
| Flow-volume<br>displayed & printed | Yes | Yes | Yes |
| Volume-time<br>printed | Yes | Yes | Yes |
| Quantifies post<br>bronchodilator<br>change | Yes | Yes | Yes |
| Prints predicted<br>flow-volume curve | Yes | Yes | Yes |
| Includes<br>interpretation<br>software | Yes | Yes | Yes |
| Results download<br>to clinical software | Yes | Yes | Yes |
| Patient result<br>storage capacity | Depending the<br>size of the data<br>storage media | Depending the size of<br>the data storage<br>media | Depending the size<br>of the data storage<br>media |
| Portable/not<br>portable | Portable with<br>laptop PC | Portable with laptop<br>PC | Portable with mobile<br>PC |
| Power source and<br>connection to PC | PC Serial<br>connection | PC USB or Serial<br>connection | PC USB or Micro<br>USB connection |
| ATS compatible | Yes | Yes | Yes |
| Flow Transducer | Disposable | Disposable | Disposable |
| Flow Transducer<br>Material | HDPE | HDPE | HDPE |
| | ExxonMobil | ExxonMobil | ExxonMobil |
| | HDPE HMA | HDPE HMA | HDPE HMA |
| | 016 | 016 | 016 |
| Pressure Tube<br>Material | 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)<br>m m<br>inch | Serial model<br>16 x 34 x 53<br>0.63 x 1.34 x 2.09 | Serial model<br>16 x 34 x 53<br>0.63 x 1.34 x 2.09<br>USB model<br>17 x 36 x 79<br>0.67 x 1.42 x 3.11 | Nano<br>14 x 26 x 56<br>0.55 x 1.02 x 2.20<br>Primo<br>13 x 30 x 107<br>0.51 x 1.18 x 4.21<br>Pro<br>13 x 30 x 107<br>0.51 x 1.18 x 4.21 |
| Weight<br>Grams<br>Ounces | Serial<br>22 g<br>0.77 oz | Serial model<br>22 g<br>0.77 oz<br>USB<br>20 g<br>0.70 oz | Nano<br>11g<br>0.39 oz<br>Primo<br>305g<br>10.76 oz<br>Pro<br>305g<br>10.76 oz |

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

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.

{5}------------------------------------------------

- 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 .

{6}------------------------------------------------

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.

{7}------------------------------------------------

#### 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

{8}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{9}------------------------------------------------

#### 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®<br>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'