Who is the manufacturer of Air Next?

Nuvoair AB filed the 510(k) submission for Air Next (K183089).

What is the FDA product code for Air Next?

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Air Next?

510(k) clearance (submission type: Traditional).

Does Air Next use AI or machine learning?

Yes. Air Next (K183089) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Air Next?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Air Next get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

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	AI/ML, Pediatric

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.

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)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### SPONSOR | Company Name: Company Address | NuvoAir AB 17 Riddargatan Stockholm 114 57 Sweden | |----------------------------------|------------------------------------------------------------| | Telephone: | +46 725538233 | | 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. {4}------------------------------------------------ # COMPARISON OF TECHNICAL CHARACTERISTICS Predicate Product Comparison Table | Feature | Subject Device | Primary Predicate K072979 | Similarities and Differences | |----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | NuvoAir | M.I.R. Medical International Research | Same | | Product Code | BZG | BZG | Same | | Regulation No, | 21 CFR 868.1840 | 21 CFR 868.1840 | Same | | Indications for Use | Air Next is intended to be used by: Healthcare professionals trained to perform spirometry tests on patients of age $\ge$ 5 years old, > 10 kg and $\ge$ 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. | The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting. | Similar indications for the use. The only difference between subject device and predicate device is that the Indications for Use in the subject device includes also weight and height while Predicate device only uses age as a limitation. Subject device is not for use in home setting. | | Use Environment | Hospital and clinical settings. | All settings that include clinical and home use | Different Use is limited to clinical settings only. | | Intended User | Trained health care professionals perform spirometry testing on Adults and pediatric patients over 5 years old | People of all ages, excluding infants and neonates. | Different | | Prescription 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. 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. 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. The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principle. 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. 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 RH: min 10 %/max 95 % ALT: max 2000 m | Temperature: MIN + 10 °C, MAX + 40 °C; Humidity: MIN 10% RH; MAX 95%RH | Same | | Physical Size | Light hand-held device | Light hand-held device | Same | | Feature | Subject Device | Primary Predicate K072979 | Similarities and Differences | | Weight | 75g | 160g | Different | | Technical Specifications | | | | | Volume accuracy | ±3% of reading or ±0.050 L, whichever is greater | ±3% of reading or ±0.050 L, whichever is 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 - Bluetooth | | Measured parameter | | | | | Forced vital capacity | FVC | FVC | Same | | Volume expired in the first | FEV0.75, FEV1, FEV3, FEV6 | FEV0.75, FEV1, FEV3, FEV6 | Same | | Ratio between volume expired in a certain time period and FVC | FEV/FVC (FER) for 0.75 /1 /3 / 6 | FEV/FVC (FER) for 0.75 /1 /3 / 6 | Same | | Peak expiratory flow | PEF | PEF | Same | | Forced expiratory flow between the first 25% and 75% of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same | | Volume inspired in the first second of the test | FIV1 | FIV1 | Same | | Forced inspiratory volume | FIVC | FIVC | Same | | Peak inspiratory flow | PIF | PIF | Same | | Feature | Subject Device | Primary Predicate K072979 | Similarities and Differences | | Forced inspiratory flow in the first 25% and 75% of the FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same | | Ratio between FEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same | | Forced expiratory flow at 50% of FVC divided by FVC | FEF50/FVC | FEF50/FVC | Same…

Air Next

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Indications for Use

Device Story

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Technological Characteristics

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Submission Summary (Full Text)

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