Who is the manufacturer of Air Next (NVD-02)?

Nuvoair AB filed the 510(k) submission for Air Next (NVD-02) (K231416).

What is the FDA product code for Air Next (NVD-02)?

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 (NVD-02)?

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

Who can help prepare an FDA 510(k) submission like Air Next (NVD-02)?

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.

Air Next (NVD-02)

K231416 · Nuvoair AB · BZG · Jan 18, 2024 · Anesthesiology

Device Facts

Record ID	K231416
Device Name	Air Next (NVD-02)
Applicant	Nuvoair AB
Product Code	BZG · Anesthesiology
Decision Date	Jan 18, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Intended Use

NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical setting, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Device Story

Hand-held spirometer (75g) for lung function testing; measures FEV1, FVC, and other respiratory parameters. Input: patient exhalation into a disposable turbine; turbine propeller rotation detected via digital infrared interruption sensor. Firmware converts rotation counts to airflow (L/s). Device connects via Bluetooth to a mobile application (iOS/Android) for data display and analysis. Used in hospitals, clinics, and home settings by patients or clinicians. Provides real-time feedback on test effort and quality per ATS 2019 guidelines. Output assists clinicians in detecting/monitoring diseases like Asthma, COPD, and Cystic Fibrosis. Benefits include portable, calibration-free lung function assessment.

Clinical Evidence

Bench testing only. Device performance validated against ATS 2019 guidelines and ISO 23747/ISO 26782 standards. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10 (cytotoxicity, irritation, sensitization).

Technological Characteristics

Hand-held spirometer; ABS-PC plastic construction. Sensing: Bidirectional turbine with infrared interruption. Power: 2x AAA 1.5V alkaline batteries. Connectivity: Bluetooth. Dimensions: 75g. Software: Mobile app-based display. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 23747, ISO 26782, IEC 62304.

Indications for Use

Indicated for lung function and spirometry testing in adults and children 5 years of age and older. Not for use in operating rooms. Users must consult a healthcare professional for clinical interpretation.

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)

Related Devices

K183089 — Air Next · Nuvoair AB · Jan 2, 2020
K222525 — Alveoair Digital Spirometer · Roundworks Technologies Private Limited · Aug 28, 2023
K241843 — TD-7301 Spirometer (TD-7301) · Gostar Co., Ltd. · Nov 20, 2024
K150137 — SpiroThor · Cohero Health, LLC · May 27, 2015
K100928 — MICRO DIARY SPIROMETER · Viasys Respiratory Care, Inc. · Mar 7, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 18, 2024 NuvoAir AB Daniel Keenan Senior Product Director, Medical Device 17D Riddargatan Stockholm. SE 11457 Stockholm, 11457 Sweden Re: K231416 Trade/Device Name: Air Next Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: December 11, 2023 Received: December 11, 2023 Dear Daniel Keenan: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. # Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, {2}------------------------------------------------ Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231416 Device Name Air Next Indications for Use (Describe) NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical setting, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. | 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." {4}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # 510(k) Summary | Date of Summary Preparation: | January 18, 2024 | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------| | 510(k) submitter & owner | NuvoAir AB 17D Riddargatan Stockholm, SE 11457 | | Contact person | Owner & contact for 510(k) submission: Furat Shawki- General Manager, CT furat.shawki@nuvoair.com (+44)755 188 3598 | | Common name of the device | Spirometer | | Trade name | Air Next | | Model number | NVD-02 | | Classification | Class II Device | | Classification name | Diagnostic Spirometer | | Product code | BZG | | Review panel | Anesthesiology | | Regulation number | 21 CFR 868.1840 | | Predicate device | | | 510(k) number | K072979 | | Trade name | Spirobank G | | Product code | BZG | | Manufacturer | MIR Medical International Research | {5}------------------------------------------------ ## 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 75g and it is powered by 2 AAA alkaline 1.5V batteries. It 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. ### Indications For Use NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical settings, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. {6}------------------------------------------------ | Predicate | K Number | Brand Name | CE Certificate | Company | |--------------|----------|---------------|--------------------------------------|---------------------------------------| | Primary | K072979 | Spirobank G | 93/42/EEC Certified No: MED 9826 | MIR Medical International Research | | Reference | K061712 | Spirobank II | NoBo:0476 Valid until: 2023-02-04 | MIR Medical International Research | | Product Code | BZG | Regulation No | 21 CFR 868.1840 | | # SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE | Characteristics | NuvoAir Air Next | Spirobank G K072979 | notes | |---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | NuvoAir | MIR Medical International Research | | | Regulation Number | 21 CFR 868.1840 | 21 CFR 868.1840 | Same | | Product Code | BZG | BZG | Same | | Indications for Use | NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical setting, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. | 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 | | Type of Use | Prescription Use | Prescription Use | Same | | User Environment | Hospitals, in the clinical setting, and at home. | In any setting | The use environment for the subject device is a subset of the predicate device use environment. | | 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. This widely spread technology circumvents the need for individual calibration by exploiting mechanical properties of the turbine, which are verified and calibrated at the time of | 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 principal. 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. | Substantially equivalent (SE) Differences do not raise new or different questions of safety or effectiveness | | Flow Sensor | Bidirectional turbine with infrared interruption | Bidirectional turbine with infrared interruption | Same | | Energy Type | Two AAA 1.5V Alkaline | 9V Alkaline battery | SE | | | batteries | | | | Display | Touchscreen on smartphone or tablet | Touchscreen / LCD and membrane keys 128 x 48 pixel, graphic LCD - FSTN | Similar | | Operating Environme nt | 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 | | Weight | 75g | 160g | Differences do not raise new or different questions of safety and effectiveness | | 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 | 0-15L/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 | | Characteristics | NuvoAir Air Next | Spirobank G K072979 | notes | | Connectivity | Bluetooth | Bluetooth or USB | Same-Bluetooth | | Forced vital capacity | FVC | FVC | Same | | Volume expired in the first 0.75sec, 1sec, 3sec, 6sec | FEV0.75, FEV1, FEV3, FEV6 | FEV0.75,FEV1,FEV3, FEV6 | Same | | between Ratio 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 | FIV 1 | FIV 1 | Same | | Forced inspiratory volume | FIVC | FIVC | Same | | Peak inspiratory flow | PIF | PIF | Same | | 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 | | Characteristics | NuvoAir Air Next | Spirobank G K072979 | notes | | 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…