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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Air Next spirometer, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Air Next spirometer meets ATS/ERS 2005 guidelines and ISO standards for spirometers. The performance of the Air Next related to specific technical specifications is compared directly to the predicate device, implying these represent the acceptance criteria derived from industry standards.

Feature / Acceptance Criteria (per ATS/ERS 2005, ISO standards, and predicate comparison)	Reported Device Performance (Air Next)
Volume Accuracy	±3% of reading or ±0.050 L, whichever is greater (Same as predicate)
Volume Range	Up to 10 L (Same as predicate)
Flow Range	0-15 L/s (Similar to predicate's 0-16 L/s)
Flow Accuracy	±5% or 200 mL/s (Same as predicate)
Flow Resistance	<0.5 cmH2O/L/s (Same as predicate)
Electrical Safety (IEC 60601-1)	Pass
Electromagnetic Compatibility (IEC 60601-1-2)	Pass
Usability (IEC 60601-1-6, IEC 62366)	Pass
Biocompatibility (ISO 10993-1, -5, -10)	Pass for Cytotoxicity, Irritation/Intracutaneous Reactivity, Irritation and Sensitization (for handle/exterior and disposable turbine through predicate equivalency)
ATS Accuracy Requirements	Yes
Performance against ATS guidelines & BTPS conditions	Results "well within range"

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for the test set for the spirometry performance characteristics (volume, flow accuracy, etc.). The performance testing described primarily refers to adherence to international standards and direct comparison of specifications with a predicate device.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be primarily lab-based performance verification against established standards rather than clinical data from human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The ground truth for the device's technical performance metrics (volume, flow accuracy, etc.) is established by recognized international standards (ATS/ERS 2005, ISO 26782, ISO 23747) and likely verified using calibrated testing equipment. There's no mention of human experts defining ground truth for these quantitative measurements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since the performance testing focuses on objective technical measurements verified against standards, an adjudication method for a "test set" in this context is not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The device is a diagnostic spirometer for basic lung function testing, not an AI-assisted diagnostic imaging device that would typically involve MRMC studies to assess human reader improvement with AI.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted. The "Performance Testing" section describes various tests against international standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-2) and the ATS/ERS 2005 guidelines. It also explicitly states that the device was tested against B.T.P.S. conditions and that "results are well within range."

The technical specifications for volume and flow accuracy are presented as direct measurements or capabilities of the device itself. While there is a comparison to a predicate device, the Air Next's own performance against these metrics constitutes standalone testing.

7. Type of Ground Truth Used

The ground truth used for the device's performance is based on established international standards and guidelines for spirometry. Specifically, the ATS/ERS 2005 guideline, EN ISO 26782:2009 (Anesthetic and respiratory equipment – Spirometers), and EN ISO 23747:2015 (Peak expiratory flowmeters) are cited. These standards define the acceptable ranges and methodologies for measuring spirometry parameters accurately.

8. Sample Size for the Training Set

This document does not describe any machine learning or AI components that would require a "training set". The Air Next is a hardware device with firmware that converts rotations into airflow measurements. Therefore, a training set sample size is not applicable in the context described.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for machine learning/AI, the method for establishing its ground truth is not applicable. The device's functionality relies on physical principles and standard conversion algorithms, not learning from data.

Summary

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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 (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

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

SPONSOR

Company Name:Company Address	NuvoAir AB17 RiddargatanStockholm 114 57Sweden
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

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 PredicateK072979	Similarities andDifferences
Manufacturer	NuvoAir	M.I.R. MedicalInternational Research	Same
Product Code	BZG	BZG	Same
Regulation No,	21 CFR 868.1840	21 CFR 868.1840	Same
Indications forUse	Air Next is intended to beused by:Healthcare professionalstrained to perform spirometrytests on patients of age$\ge$ 5 years old, > 10 kgand $\ge$ 110 cm.Air Next is intended toperform basic lung functionand spirometry testing.The actual diagnosis shall bedone by a healthcareprofessional in hospital andclinical settings.	The Spirobank Gspirometer is intended tobe used by a physician orby a patient under theinstruction of a physicianor paramedic. The deviceis intended to test lungfunction and can makespirometry testing inpeople of all ages,excluding infants andneonates. It can be usedin any setting.	Similarindications forthe use. The onlydifferencebetween subjectdevice andpredicate deviceis that theIndications forUse in the subjectdevice includesalso weight andheight whilePredicate deviceonly uses age as alimitation. Subjectdevice is not foruse in homesetting.
UseEnvironment	Hospital and clinicalsettings.	All settings thatinclude clinical andhome use	DifferentUse is limited toclinical settingsonly.
Intended User	Trained health careprofessionals performspirometry testing onAdults and pediatric patientsover 5 years old	People of all ages,excluding infants andneonates.	Different
Prescriptiononly	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° CRH: 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 PredicateK072979	Similarities andDifferences
Weight	75g	160g	Different
Technical Specifications
Volumeaccuracy	±3% of reading or±0.050 L, whichever is greater	±3% of reading or±0.050 L, whichever isgreater	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 vitalcapacity	FVC	FVC	Same
Volume expiredin the first	FEV0.75, FEV1, FEV3, FEV6	FEV0.75, FEV1, FEV3, FEV6	Same
Ratio betweenvolume expiredin a certaintime periodand FVC	FEV/FVC (FER) for 0.75 /1/3 / 6	FEV/FVC (FER) for 0.75/1 /3 / 6	Same
Peak expiratoryflow	PEF	PEF	Same
Forcedexpiratory flowbetween thefirst 25% and75% of the FVC	FEF25-75 (MEF)	FEF25-75 (MEF)	Same
Volumeinspired in thefirst second ofthe test	FIV1	FIV1	Same
Forcedinspiratoryvolume	FIVC	FIVC	Same
Peak inspiratoryflow	PIF	PIF	Same
Feature	Subject Device	Primary PredicateK072979	Similarities andDifferences
Forcedinspiratory flowin the first 25%and 75% of theFIV	FIF25-75 (MIF25-75)	FIF25-75 (MIF25-75)	Same
Ratio betweenFEV1 and FEV6	FEV1/FEV6	FEV1/FEV6	Same
Forcedexpiratory flowat 50% of FVCdivided by FVC	FEF50/FVC	FEF50/FVC	Same
Forcedinspiratory flowin the first 25%and 75% of theFIV	FIF25-75 (MIF25-75)	FIF25-75 (MIF25-75)	Same
Ratio betweenFEV1 and FEV6	FEV1/FEV6	FEV1/FEV6	Same
Forcedexpiratory flowat 50% of FVCdivided by FVC	FEF50/FVC	FEF50/FVC	Same
Forceinspiratory flowat first seconddevice forcedinspiratoryvolume	FIV1/FIVC (FIR)	FIV1/FIVC (FIR)	Same
Forcedexpiratory time	FET	FET	Same
Maximumvoluntaryventilation	N/A	MVV (ind)	Different
Device Use Design
Used with PFTfilter and / ormouthpiece	Mouthpiece Disposable	Mouthpiece Disposable orReusable	Same for DisposableTurbine – Seereference predicatechart below
Coaching	Display of flow-time curves,timer and effort during test	Display of volume-time andflow-volume curves	Different
Feedback ontest quality	Yes - according to ATSguidelines	Yes – Traffic lights forinterpretation	Similar
Graphic display	Yes- on App	Yes on device screen	Different
Safety Standards
Feature	Subject Device	Primary PredicateK072979	Similarities andDifferences
AppliedStandards forsafety	Electrical Safety StandardIEC 60601-1Electro Magnetic CompatibilityIEC 60601-1-2	Electrical Safety StandardIEC 60601-1Electro MagneticCompatibilityIEC 60601-1-2	Same
AppliedStandards forsafety	Electrical Safety StandardIEC 60601-1Electro Magnetic CompatibilityIEC 60601-1-2	Electrical Safety StandardIEC 60601-1Electro MagneticCompatibilityIEC 60601-1-2	Same
Biocompatibility	According to ISO 10993-1	According to ISO 10993-1	Same
Meets ATSaccuracyrequirements	Yes	Yes	Same

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Reference Device

The disposable turbine used in Air Next device is manufactured and purchased from MIR Medical International Research and is cleared under K061712. The disposable turbine is supplied in its final finished form and is identical to the reference predicate device.

PERFORMANCE TESTING

The following performance data were provided in support of the substantial equivalence determination.

Safety testing

Testing Standard	Test Description	Result
IEC 60601-1:2005 (Third Edition)+ CORR. 1:2006 + CORR. 2:2007 +A1:2012	Medical electrical equipment - Part 1: generalrequirements for basic safety and essentialperformance	Pass
IEC 60601-1-6:2010, AMD1:2013	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability	Pass
IEC 62366:2007	Medical devices – Application of usability engineeringto medical devices	Pass
IEC · 60601-1-2:2014 (ED. 4)	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests	Pass

Biocompatibility

Handle and Exterior Surface

The Handle and Exterior is designed to be a surface device for intact skin with limited contact A – limited (≤24 h). The following testing was performed:

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Based on the device categorization outlined above, the material contact and the guidance given in ISO 10993-1, the tests deemed appropriate for the device materials were selected as shown in the table below.

Biological Effect	Test	ComplianceStandard
Cytotoxicity	Mem Elution	ISO10993-5
Irritation or IntracutaneousReactivity	Intracutaneous Injection Test	ISO10993-10
Irritation and Sensitization	Kligman Maximization test	ISO10993-10

Disposable Turbine

NuvoAir Turbines are disposable turbines intended for single use for a period of less than 24hr. NuvoAir has provided a declaration statement from the legal manufacturer, MIR, stating that the NuvoAir disposable turbine for Air Next Spirometer (ref. code 910007) is identical in its final finished form to the disposable turbine legally marketed and identified with code 910004 and that this turbine is in turn legally US-marketed Spirobank II (K061712).

Additional Testing Standards

ATS/ERS 2005 guideline ●
ISO 14971:2007 - Application of risk management to medical devices.
IEC 62366:2007 + A1:2014. Application of usability engineering to medical devices.
ISO 62304:2006/A1:2015: Medical device software. Software life-cycle processes
EN ISO 26782: 2009, Anesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans
. EN ISO 23747:2015, Anesthesia and respiratory equipment - Peak expiratory flowmeters for the assessment of pulmonary function in spontaneously breathing humans
. FCC Part 15, Subpart B, C

Clinical testing was not performed with this device.

Substantial Equivalence Conclusion:

Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance we believe we have demonstrated that the Air Next is substantially equivalent and as effective as the predicate device. Furthermore, the differences versus the predicate device do not impact safety and effectiveness.

Regulation Number and Section

§ 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).