(371 days)
No
The description details standard spirometry calculations based on airflow measurements and ATS/ERS guidelines, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is described as a diagnostic tool for measuring lung function parameters, not for treating conditions.
Yes
Explanation: The device is a spirometer intended "to conduct basic lung function and spirometry testing" and measures "lung function parameters" to generate a "test report". This aligns with the definition of a diagnostic device which is used to identify or measure a disease or condition.
No
The device description explicitly states that the system includes the "alveoair Digital Spirometer," which is a physical device that utilizes infrared interruption and a turbine to measure airflow. While it uses software (mobile application and cloud server) for data processing and display, it is not solely software.
Based on the provided information, the alveoair Digital Spirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Alveoair Function: The alveoair Digital Spirometer measures lung function by analyzing the airflow and volume of air exhaled and inhaled by a patient. It does not analyze any biological specimens from the body.
- Intended Use: The intended use clearly states it's for "basic lung function and spirometry testing," which is a physiological measurement, not an in vitro analysis of a specimen.
Therefore, the alveoair Digital Spirometer falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The alveoarr Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged > 22 years by healthcare professionals or clinicare environment. The use of an alveoair Digital Spirometer is not intended for use during patient transport.
Product codes
BZG
Device Description
The alveoair Digital Spirometer is used to test lung function in people of all ages ≥ 22 years. It is intended to be used by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer was designed, developed, and manufactured at Roundworks Technologies Pvt Ltd. The model number is indicated below:
| Model
| Number | Model Name | Model Description |
|---|---|---|
| ALV002 | alveoair Digital | |
| Spirometer | Digital Spirometer to measure lung function | |
| parameters |
The alveoair Digital Spirometer system includes:
- alveoair Digital Spirometer .
- alveoMD mobile application .
- . alveofit API Cloud server backend
The alveoair Digital Spirometer is intended to be used and compatible only with the flowMIR disposable turbine and cardboard mouthpiece manufactured by the Medical International Research s.r.l. The accessories are 510k cleared under K061712 and it is single-use disposable. Roundworks Technologies Pvt Ltd recommends the user to purchase the sinqle-use disposable flowMIR turbine on their own. One sample piece of the flowMIR (Ref. code: 910004) disposable turbine sensor and disposable cardboard mouthpiece is provided in the packaging. Roundworks recommends that the user purchase the same model turbine and mouthpiece from Medical International Research s.r.l. for further use.
The alveoair digital spirometer is available in two different colors. The internal components, software, and function remain the same for both devices. The only difference is the color of the case; one is completely black and the other is a combination of black and white.
The alveoair Digital Spirometer is used in combination with a turbine and mouthpiece. It utilizes a smartphone with a dedicated mobile application (alveoMD) and a cloud server (alveoFit) to view and store spirometer readings. This portable spirometer operates on the principle of infrared interruption. To perform a test, the user inhales and exhales air through the mouthpiece, which then flows into the turbine. The turbine's propeller rotates in both clockwise and counterclockwise directions, depending on the airflow. The firmware within the device calculates a series of volume and flow coordinates, in liters with respect to time in seconds, every time an interrupt data is received from the IR sensor. This process continues for 20 seconds or until the flow change calculated is less than 0.025 liters per second. When the patient inhales/exhales air into the spirometer during the standard or full loop tests. Once the test is completed, all coordinates are transferred to the mobile application using BLE. From there, the data is uploaded to the alveofit API Cloud server via the internet.
For the alveoMD app, an internet connection is required to initiate the spirometry test. The alveoFit cloud server takes in the coordinates to calculate all lung parameters. Once the process is completed, a test report will be generated and displayed in the alveoMD mobile application. The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
≥ 22 years
Intended User / Care Setting
healthcare professionals or clinicians in any healthcare environment. Doctor's office or hospitals, and clinics.
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)
The alveoair digital spirometer complies with the following standards:
Electrical Safety and EMC:
-
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
-
- IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
-
- IEC 60601-1-2:2014+AMD1:2020 CSV Consolidated version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software:
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes.
Cybersecurity:
-
- Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity.
Biocompatibility:
- . Handheld Subject Device Contact Type and Duration: Surface Intact skin, limited duration (≤24 hr)
- Turbine and mouthpiece contact the patient's gas pathway (cleared K061712) ●
-
- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
-
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.
-
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices -Part 10: Tests for skin sensitization.
-
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation.
Risk Management:
-
- ISO 14971:2019 Medical devices Application of risk management to medical devices.
Labels & IFU:
-
- ISO 15223-1 Fourth edition 2021-07 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
-
- ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -Information to be supplied by the manufacturer.
Performance:
-
- ISO 26782:2009 Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time-forced expired volumes in humans.
-
- ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans.
-
- ATS/ERS 2019 guideline Standardization of Spirometry 2019 Update an Official American Thoracic Society and European Respiratory Society Technical Statement.
Usability:
-
- Guidance for Applying Human Factors and Usability Engineering to Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Air Next (K183089)
Reference Device(s)
Spirobank G (K072979)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
August 28, 2023
Roundworks Technologies Private Limited % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 India
Re: K222525
Trade/Device Name: alveoair Digital Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: July 27, 2023 Received: July 27, 2023
Dear Ankur Naik:
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
1
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 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 (QS) 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 medical devices and radiation-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, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222525
Device Name alveoair Digital Spirometer
Indications for Use (Describe)
The alveoarr Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged > 22 years by healthcare professionals or clinicare environment. The use of an alveoair Digital Spirometer is not intended for use during patient transport.
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
510(K) summary of safety and effectiveness for alveoair Digital Spirometer is provided in accordance with 21 CFR 807.92.
| Date: | 28 August 2023 |
|---|---|
| Submitter (Owner): | Prashant Patel |
| Founder & CEO | |
| Roundworks Technologies Private Limited. | |
| Office No. B 302, Building No. B, 3rd floor, | |
| GO Square, Survey No. 249/250, Above Surya | |
| Electronics, Wakad, Pune - 41104, India. | |
| P: +91 7507776273 | |
| Email: prashant@alveo.fit | |
| 510(k) Contact Person: | Ankur Naik |
| Managing Director | |
| IZiel Healthcare | |
| 14, Hadapsar Industrial Estate, | |
| Hadapsar, Pune – 411013, India. | |
| P: +91 72762 2555 M: +91 7069553814 | |
| Email: ankur.naik@izielhealthcare.com | |
| Device Trade Name: | alveoair Digital Spirometer |
| Regulation Number: | 21 CFR 868.1840 |
| Review Panel: | Anesthesiology |
| Device Class: | Class II |
| Product Code: | BZG |
| Predicate Device: | Air Next (K183089) |
| Reference device: | Spirobank G (K072979) |
Device Description
The alveoair Digital Spirometer is used to test lung function in people of all ages ≥ 22 years. It is intended to be used by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer was designed, developed, and manufactured at Roundworks Technologies Pvt Ltd. The model number is indicated below:
| Model
| Number | Model Name | Model Description |
|---|---|---|
| ALV002 | alveoair Digital | |
| Spirometer | Digital Spirometer to measure lung function | |
| parameters |
The alveoair Digital Spirometer system includes:
- alveoair Digital Spirometer .
4
- alveoMD mobile application .
- . alveofit API Cloud server backend
The alveoair Digital Spirometer is intended to be used and compatible only with the flowMIR disposable turbine and cardboard mouthpiece manufactured by the Medical International Research s.r.l. The accessories are 510k cleared under K061712 and it is single-use disposable. Roundworks Technologies Pvt Ltd recommends the user to purchase the sinqle-use disposable flowMIR turbine on their own. One sample piece of the flowMIR (Ref. code: 910004) disposable turbine sensor and disposable cardboard mouthpiece is provided in the packaging. Roundworks recommends that the user purchase the same model turbine and mouthpiece from Medical International Research s.r.l. for further use.
The alveoair digital spirometer is available in two different colors. The internal components, software, and function remain the same for both devices. The only difference is the color of the case; one is completely black and the other is a combination of black and white.
The alveoair Digital Spirometer is used in combination with a turbine and mouthpiece. It utilizes a smartphone with a dedicated mobile application (alveoMD) and a cloud server (alveoFit) to view and store spirometer readings. This portable spirometer operates on the principle of infrared interruption. To perform a test, the user inhales and exhales air through the mouthpiece, which then flows into the turbine. The turbine's propeller rotates in both clockwise and counterclockwise directions, depending on the airflow. The firmware within the device calculates a series of volume and flow coordinates, in liters with respect to time in seconds, every time an interrupt data is received from the IR sensor. This process continues for 20 seconds or until the flow change calculated is less than 0.025 liters per second. When the patient inhales/exhales air into the spirometer during the standard or full loop tests. Once the test is completed, all coordinates are transferred to the mobile application using BLE. From there, the data is uploaded to the alveofit API Cloud server via the internet.
For the alveoMD app, an internet connection is required to initiate the spirometry test. The alveoFit cloud server takes in the coordinates to calculate all lung parameters. Once the process is completed, a test report will be generated and displayed in the alveoMD mobile application. The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019.
Intended Use / Indications for Use
The alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22 years by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer is not intended for use during patient transport.
5
Comparison to predicate devices
Table 1: Comparison to Predicate Device
| Comparable
Properties | Subject Device | Predicate Device
(K183089) | Reference Device
(K072979) | Comparison
Results |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | alveoair Digital
Spirometer | Air Next | Spirobank G | Not applicable |
| Manufacturer | Roundworks
Technologies Pvt Ltd. | NuvoAir AB | M.I.R. Medical
International
Research | Not applicable |
| Classification
Name | Spirometer, Diagnostic | Spirometer,
Diagnostic | Spirometer,
Diagnostic | Identical |
| Regulation
number | 21 CFR 868.1840 | 21 CFR 868.1840 | 21 CFR 868.1840 | Identical |
| Product code | BZG | BZG | BZG | Identical |
| Product Class | Class II | Class II | Class II | Identical |
| Intended Use /
Indications for Use | The alveoair Digital
Spirometer is intended to
conduct basic lung
function and spirometry
testing on patients aged
≥ 22 years by healthcare
professionals or
clinicians in any
healthcare environment.
The alveoair Digital
Spirometer is not
intended for use during
patient transport. | 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 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.
lt can be used in any
setting. | Substantially
Equivalent |
| Comparable Properties | Subject Device | Predicate Device (K183089) | Reference Device (K072979) | Comparison Results |
| | | The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings. | | |
| Target Population | Patients aged ≥ 22 years old. | Patients of age ≥ 5 years old, > 10 kg, and ≥ 110 cm. | All ages, excluding infants and neonate. | Substantially Equivalent |
| Intended User | Health care Professionals or clinicians | Trained health care Professionals. | People of all ages, excluding infants and Neonates. | Substantially Equivalent |
| Prescription / Over the counter | Prescription | Prescription | Prescription | Identical |
| Use Environment | Doctor's office or hospitals, and clinics | Hospital and clinical settings | It can be used in any setting | Identical |
| Principle Operation | The alveoair Digital Spirometer is designed to be used in combination with a turbine and a mouthpiece. It functions as a portable spirometer, operating on the infrared interruption principle. The airflow generated by the user's breath forces a propeller to rotate inside the turbine. The direction of the turbine's rotation, whether clockwise or anti- | 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 | 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, | Substantially Equivalent |
| Comparable
Properties | Subject Device | Predicate Device
(K183089) | Reference Device
(K072979) | Comparison
Results |
| | clockwise, depends on
the flow direction. | interruption sensor.
The
algorithm in the | based on the infrared
interruption
principle. | |
| | To measure the
respiratory parameters
accurately, the
spirometer's sensor
tracks the propeller's
rotations and calculates
its spinning speed
concerning time. The
device's firmware
processes this data and
computes a series of
volume and flow
coordinates in liters per
second whenever an
interrupt data is received
from the IR sensor. | 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 | Spirometry test
interpretation is
based on the Forced
Vital Capacity
(FVC) test and is
based on the ATS
standard. | |
| Technical Features | | | | |
| Flow Sensor | Bidirectional digital
turbine with infrared
interruption | Bidirectional turbine
with
infrared interruption | Bidirectional turbine
with infrared
interruption | Identical |
| Physical Characteristics | | | | |
| Size | 112 x 55 x 21mm; | 98 x 62 x 26mm | 109 x 49 x 21mm | Substantially
Equivalent |
| Weight | Central unit 76g
(including batteries) | 75g | 160g | Substantially
Equivalent |
| Energy Type | 2 x 1.5V, AAA batteries | 2 x 1.5V, AAA
Alkaline | 9V Alkaline battery | Identical to
Predicate Device |
| Comparable
Properties | Subject Device | Predicate Device
(K183089) | Reference Device
(K072979) | Comparison
Results |
| Display | The touchscreen on
smartphone or
tablet | The touchscreen on
smartphone or
tablet | Touchscreen / LCD
and membrane | Identical to
Predicate Device |
| Operating
Environment | Temp: MIN: +10°C,
MAX: +40°C
Humidity: MIN: 10% RH,
MAX: 95% RH | Temp: MIN: +10°C,
MAX: +40°C
RH: MIN: 10%, MAX:
95%
ALT: MAX: 2000 m | Temp: MIN: +10°C,
MAX: +40°C.
Humidity: MIN: 10%
RH, MAX: 95% RH | Identical |
| Technical Specifications | | batteries | | |
| Volume range and
accuracy | Up to 8L
±2.5% of reading or
±0.050 L, whichever is
greater | Up to 10L
±3% of reading or
±0.050 L, whichever
is greater | Up to 10L
±3% of reading or
±0.050 L, whichever
is greater | Substantially
equivalent as the
subject device is
compliant to the
requirements of
American Thoracic
Society (ATS)
Standardization of
Spirometry 2019
update and ISO
26782: 2009 |
| Flow range and
accuracy | 0 - 14 L/s
±10% or 0.17 L/s | 0-15 L/s
±5% or 200 mL/s | 0-16 L/s
±5% or 200 mL/s | Substantially
equivalent as the
subject device is
compliant to the
requirements of
ISO 23747:2015 |
| Flow resistance |