(422 days)
No
The summary describes a standard spirometer that measures lung function parameters. There is no mention of AI, ML, or related technologies in the device description, intended use, or performance studies.
No.
The device is intended for basic lung function and spirometry testing to measure parameters for the detection, assessment, and monitoring of diseases, but the actual diagnosis is to be done by a healthcare professional, indicating it's a diagnostic/monitoring tool, not a therapeutic one.
Yes
Justification: The device is intended to perform "basic lung function and spirometry testing" to measure parameters like FEV1 and FVC, "which can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis." This clearly indicates its use in diagnosing and managing medical conditions. While the description states "The actual diagnosis shall be done by a healthcare professional," the device provides the data essential for that diagnosis, classifying it as a diagnostic tool.
No
The device description explicitly states that Air Next is a hand-held spirometer weighing 75g, powered by batteries, and includes the physical Air Next device and a disposable turbine, in addition to the mobile application. This indicates it is a hardware device with accompanying software.
Based on the provided information, the Air Next device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Air Next device measures lung function directly from the patient's breath, not from a biological sample taken from the body.
- The intended use describes a device for performing basic lung function and spirometry testing. This is a physiological measurement, not a test performed on a biological specimen.
- The device description details a hand-held spirometer that measures parameters like FEV1 and FVC. These are measurements of airflow and volume during breathing, not analyses of biological components.
While the results from the Air Next can be used by healthcare professionals to aid in the diagnosis and monitoring of diseases, the device itself does not perform the diagnostic test on a biological sample, which is the defining characteristic of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
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. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patients of age ≥ 5 years old. The predicate device mentions "People of all ages, excluding infants and neonates."
Intended User / Care Setting
Healthcare professionals trained to perform spirometry tests in hospital and clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included:
- Safety testing according to IEC 60601-1:2005, IEC 60601-1-6:2010, IEC 62366:2007, IEC 60601-1-2:2014. All tests passed.
- Biocompatibility testing for the handle and exterior surface (contact with intact skin, limited duration ≤24 h) according to ISO 10993-1, including Cytotoxicity (Mem Elution, ISO10993-5), Irritation or Intracutaneous Reactivity (Intracutaneous Injection Test, ISO10993-10), and Irritation and Sensitization (Kligman Maximization test, ISO10993-10).
- The disposable turbine is identical to the one cleared under K061712.
- The device meets ATS accuracy requirements.
- Clinical testing was not performed with this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
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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 |