Air Next

K183089 · Nuvoair AB · BZG · Jan 2, 2020 · Anesthesiology

Device Facts

• Record ID: K183089
• Device Name: Air Next
• Applicant: Nuvoair AB
• Product Code: BZG · Anesthesiology
• Decision Date: Jan 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Air Next is intended to be used by: Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and ≥ 110 cm. Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.

Device Story

Hand-held spirometer (75g) measures lung function via disposable turbine; user exhales into turbine; airflow rotates propeller; digital infrared interruption sensor counts rotations; firmware converts rotations to airflow (L/s). Device connects via Bluetooth to mobile application (iOS/Android) for display of flow-time curves, effort, and test quality feedback. Used by trained healthcare professionals in clinical settings to assist in diagnosis of asthma, COPD, and cystic fibrosis. Benefits include portable, accurate lung function assessment compliant with ATS/ERS guidelines.

Clinical Evidence

No clinical data. Bench testing only. Device performance validated against ATS/ERS 2005 guidelines for spirometry accuracy (volume accuracy ±3% or ±0.050 L; flow accuracy ±5% or 200 mL/s). Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5, -10) testing passed.

Technological Characteristics

Hand-held spirometer (98x62x26 mm, 75g). Powered by 2x AAA 1.5V alkaline batteries. Sensing: Bidirectional turbine with infrared interruption. Connectivity: Bluetooth. Software: Mobile app-based display. Biocompatibility: ISO 10993-1 compliant. Safety: IEC 60601-1, IEC 60601-1-2, IEC 62366. Sterilization: Disposable turbine (single-use).

Indications for Use

Indicated for patients ≥ 5 years old, > 10 kg, and ≥ 110 cm for basic lung function and spirometry testing (FEV1, FVC) to detect, assess, and monitor lung diseases like asthma, COPD, and cystic fibrosis. For use by trained healthcare professionals in hospital/clinical settings.

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

• Spirobank G (K072979)

Reference Devices

• Spirobank II (K061712)

Submission Summary (Full Text)

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January 2, 2020

Image /page/0/Picture/1 description: The image shows 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.

NuvoAir AB % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K183089

Trade/Device Name: Air Next Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: December 20, 2019 Received: December 30, 2019

Dear Yolanda Smith:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Michael Rvan 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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## Indications for Use

510(k) Number (if known) K183089

Device Name Air Next

Indications for Use (Describe)

Air Next is intended to be used by:

Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and > 110 cm.

Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

#### SPONSOR

| Company Name:<br>Company Address | NuvoAir AB<br>17 Riddargatan<br>Stockholm 114 57<br>Sweden |
|----------------------------------|------------------------------------------------------------|
| Telephone: | [phone] |
| Contact Person: | Vanessa Caldeira |

Summary Preparation Date: December 31, 2019

### DEVICE NAME

| Trade Name: | Air Next |
|----------------------|-----------------------|
| Common/Usual Name: | Spirometer |
| Classification Name: | Diagnostic Spirometer |
| Regulation Number: | 21 CFR 868.1840 |
| Product Code: | BZG |
| Device Class: | Class II |
| Reviewing Panel: | Anesthesiology |

### PREDICATE DEVICE

Legally Marketed Equivalent Device

| Predicate | K Number | Brand Name | Company |
|-----------|----------|--------------|------------------------------------|
| Primary | K072979 | Spirobank G | MIR Medical International Research |
| Reference | K061712 | Spirobank II | MIR Medical International Research |

## DEVICE DESCRIPTION

Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.

Air Next is a hand-held spirometer, weighing only 75g and it is powered by 2 AAA alkaline 1.5V batteries. lt consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores. The package includes one Air Next device, one NuvoAir disposable turbine through which the user can start using the Air Next, two AAA 1.5V alkaline batteries, one user manual and one cotton bag to carry the device. Dimensions of the Air Next are 98 x 62 x 26 mm, which can be seen in the engineering drawing in the attachments.

## DEVICE INDICATIONS FOR USE

Air Next is intended to be used by:

Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and ≥ 110 cm.

Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a dentist or physician.

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# COMPARISON OF TECHNICAL CHARACTERISTICS

Predicate Product Comparison Table

| Feature | Subject Device | Primary Predicate<br>K072979 | Similarities and<br>Differences |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NuvoAir | M.I.R. Medical<br>International Research | Same |
| Product Code | BZG | BZG | Same |
| Regulation No, | 21 CFR 868.1840 | 21 CFR 868.1840 | Same |
| Indications for<br>Use | Air Next is intended to be<br>used by:<br>Healthcare professionals<br>trained to perform spirometry<br>tests on patients of age<br>$\ge$ 5 years old, > 10 kg<br>and $\ge$ 110 cm.<br>Air Next is intended to<br>perform basic lung function<br>and spirometry testing.<br>The actual diagnosis shall be<br>done by a healthcare<br>professional in hospital and<br>clinical settings. | The Spirobank G<br>spirometer is intended to<br>be used by a physician or<br>by a patient under the<br>instruction of a physician<br>or paramedic. The device<br>is intended to test lung<br>function and can make<br>spirometry testing in<br>people of all ages,<br>excluding infants and<br>neonates. It can be used<br>in any setting. | Similar<br>indications for<br>the use. The only<br>difference<br>between subject<br>device and<br>predicate device<br>is that the<br>Indications for<br>Use in the subject<br>device includes<br>also weight and<br>height while<br>Predicate device<br>only uses age as a<br>limitation. Subject<br>device is not for<br>use in home<br>setting. |
| Use<br>Environment | Hospital and clinical<br>settings. | All settings that<br>include clinical and<br>home use | Different<br>Use is limited to<br>clinical settings<br>only. |
| Intended User | Trained health care<br>professionals perform<br>spirometry testing on<br>Adults and pediatric patients<br>over 5 years old | People of all ages,<br>excluding infants and<br>neonates. | Different |
| Prescription<br>only | Yes | Yes | Same |
| Feature | Subject Device | Primary Predicate K072979 | Similarities and Differences |
| Principle of Operation | The Air Next is designed to work with NuvoAir disposable turbine. When performing a spirometry test, the user exhales into the turbine. The airflow generated is forcing a propeller to rotate inside the turbine. The Air Next registers the speed of the spinning propeller by counting the rotations with a digital infrared interruption sensor. The algorithm in the firmware inside the Air Next device then converts the rotations into airflow measured in liters per second.<br>The device is also tested against B.T.P.S. (body temperature and pressure with saturated water vapor) conditions as prescribed by ATS guidelines and the results are well within range. | Spirobank G is a powerful and compact measurement device, intended for use by a respiratory specialist or by a suitably trained generalist.<br>Two different types of turbine sensors can be used with the device, one is reusable and one is single-patient disposable. A disposable mouthpiece is required in order to connect a subject to the spirometer.<br>The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principle.<br>Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after use.<br>Spirometry test interpretation is based on the Forced Vital Capacity (FVC) test and is based on the ATS standard. | Same |
| Flow Sensor | Bidirectional turbine with infrared interruption | Bidirectional turbine with infrared | Same |
| Physical Characteristics | | | |
| Energy Type | Two AAA 1.5V Alkaline batteries | 9V Alkaline battery | Different |
| Display | Touchscreen on smartphone or tablet | Touchscreen / LCD and membrane | Different |
| Operating Environment | T: min +10°C/max +40° C<br>RH: min 10 %/max 95 % ALT: max 2000 m | Temperature: MIN + 10 °C, MAX + 40 °C;<br>Humidity: MIN 10% RH; MAX 95%RH | Same |
| Physical Size | Light hand-held device | Light hand-held device | Same |
| Feature | Subject Device | Primary Predicate<br>K072979 | Similarities and<br>Differences |
| Weight | 75g | 160g | Different |
| Technical Specifications | | | |
| Volume<br>accuracy | ±3% of reading or<br>±0.050 L, whichever is greater | ±3% of reading or<br>±0.050 L, whichever is<br>greater | Same |
| Volume range | Up to 10 L | Up to 10 L | Same |
| Flow range | 0-15/s | 0-16 L/s | Similar |
| Flow accuracy | ±5% or 200 mL/s | ±5% or 200 mL/s | Same |
| Flow resistance | <0.5 cmH2O/L/s | <0.5 cmH2O/L/s | Same |
| Connectivity | Bluetooth | Bluetooth of USB | Same -<br>Bluetooth |
| Measured parameter | | | |
| Forced vital<br>capacity | FVC | FVC | Same |
| Volume expired<br>in the first | FEV0.75, FEV1, FEV3, FEV6 | FEV0.75, FEV1, FEV3, FEV6 | Same |
| Ratio between<br>volume expired<br>in a certain<br>time period<br>and FVC | FEV/FVC (FER) for 0.75 /1<br>/3 / 6 | FEV/FVC (FER) for 0.75<br>/1 /3 / 6 | Same |
| Peak expiratory<br>flow | PEF | PEF | Same |
| Forced<br>expiratory flow<br>between the<br>first 25% and<br>75% of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same |
| Volume<br>inspired in the<br>first second of<br>the test | FIV1 | FIV1 | Same |
| Forced<br>inspiratory<br>volume | FIVC | FIVC | Same |
| Peak inspiratory<br>flow | PIF | PIF | Same |
| Feature | Subject Device | Primary Predicate<br>K072979 | Similarities and<br>Differences |
| Forced<br>inspiratory flow<br>in the first 25%<br>and 75% of the<br>FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio between<br>FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced<br>expiratory flow<br>at 50% of FVC<br>divided by FVC | FEF50/FVC | FEF50/FVC | Same…