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.

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: 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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for the alveoair Digital Spirometer's performance or a study proving that the device meets these criteria in the way typically found for AI/ML-based medical devices (e.g., sensitivity, specificity, or performance against human readers).

The document focuses on demonstrating substantial equivalence to a predicate device (Air Next, K183089) and a reference device (Spirobank G, K072979) primarily through comparison of technical specifications, intended use, and adherence to relevant medical device standards.

However, based on the information provided, I can infer some aspects of what would constitute "acceptance criteria" for a spirometer and what studies were referenced to show compliance.

Here's an analysis based on the provided text, addressing the points where information is available or can be reasonably inferred within the context of a spirometer's regulatory submission:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria for the alveoair Digital Spirometer are primarily derived from the industry standards it claims to comply with, particularly ISO 26782:2009 for spirometers and ISO 23747:2015 for peak expiratory flow meters, as well as the ATS/ERS 2019 guidelines. These standards define the required accuracy and precision for spirometry measurements.

Table of Acceptance Criteria (Inferred from Standards Compliance) and Reported Device Performance:

Parameter	Acceptance Criteria (Inferred from Standards)	Reported Device Performance
Volume Accuracy	According to ISO 26782:2009, typically requires accuracy within ±3% of reading or ±0.050 L (whichever is greater) for forced expiratory volumes.	Up to 8L±2.5% of reading or ±0.050 L, whichever is greater
Flow Accuracy	According to ISO 23747:2015 (for PEF meters), typically requires accuracy within ±10% or ±(a specified flow unit, e.g., 0.17 L/s).	0 - 14 L/s±10% or 0.17 L/s
Flow Resistance	According to relevant standards (e.g., ISO 26782), typically must be less than 0.5 cmH2O/L/s.	<0.5 cmH2O/L/s
Measurement Range	Sufficient for adult spirometry (e.g., volume up to 8-10L, flow up to 14-16 L/s).	Volume: Up to 8LFlow: 0 - 14 L/s
BTPS Compliance	Must account for Body Temperature and Pressure, Saturated with water vapor (BTPS) corrections per ATS guidelines.	"The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019." (Implies BTPS calculations)

Note: The document explicitly states "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" for Volume range and accuracy, and "Substantially equivalent as the subject device is compliant to the requirements of ISO 23747:2015" for Flow range and accuracy. This indicates that compliance with these standards (which contain the acceptance criteria) is the basis for demonstrating performance.

Study Details Proving Device Meets Acceptance Criteria

The provided text does not describe a specific clinical study or an AI/ML specific performance study with test sets, ground truth establishment, expert adjudication, or MRMC studies. Instead, it relies on demonstrating compliance with recognized standards.

Here's an attempt to address your points based on the available information, noting when information is not provided or not applicable to this type of device/submission:

A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria are inferred from the standards the device claims to meet (ISO 26782, ISO 23747, ATS/ERS 2019), and the reported performance is directly stated in the "Technical Specifications" comparison table.
Sample sizes used for the test set and the data provenance:
- Not provided. The document refers to compliance with performance standards, which typically involve testing with calibrated flow/volume simulators, not necessarily a "test set" of patient data in the AI/ML context. If simulated data was used for testing against standards, its provenance isn't specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For spirometers, "ground truth" for performance testing is established using highly accurate, calibrated flow and volume sources that can deliver specific waveforms and volumes according to the standards (e.g., defined by ATS/ERS or ISO). It's not typically established by human experts in the same way as an imaging AI device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This method is characteristic of studies involving human interpretation or annotation of data, which is not the primary method for demonstrating performance of a spirometer. Performance is verified against calibrated instruments.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not done. The alveoair Digital Spirometer is a diagnostic spirometer, not an AI-assisted diagnostic tool for human interpretation. Its function is to measure lung function parameters, which are then used by healthcare professionals. No "AI assistance" to human readers is mentioned or implied.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs the measurements digitally. However, its performance is evaluated against the technical requirements of spirometry standards, not as an AI algorithm that makes diagnostic predictions without human oversight. The device calculates parameters (FVC, FEV1, etc.) as per ATS/ERS guidelines. This is the "algorithm only" performance for a spirometer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Calibrated mechanical/electronic simulators. For spirometers, the ground truth for performance testing is established by highly accurate, traceable calibration equipment that precisely controls and measures airflow and volume according to defined waveforms (e.g., those specified in ISO 26782 or ATS/ERS guidelines).
The sample size for the training set:
- Not applicable/Not provided. This is relevant for AI/ML device development. This spirometer, based on the description, operates on an infrared interruption principle to measure physical parameters and applies direct calculations based on established physiological formulas (like those in ATS/ERS guidelines). It's not described as an AI/ML algorithm that requires a "training set" in the conventional sense.
How the ground truth for the training set was established:
- Not applicable. As no training set for an AI/ML algorithm is described, this question is not relevant. The "ground truth" for the device's internal calculations is embedded in the standardized physiological equations and the accuracy of its physical sensors compared to calibrated references.

Summary

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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

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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

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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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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 PatelFounder & CEORoundworks Technologies Private Limited.Office No. B 302, Building No. B, 3rd floor,GO Square, Survey No. 249/250, Above SuryaElectronics, Wakad, Pune - 41104, India.P: +91 7507776273Email: prashant@alveo.fit
510(k) Contact Person:	Ankur NaikManaging DirectorIZiel Healthcare14, Hadapsar Industrial Estate,Hadapsar, Pune – 411013, India.P: +91 72762 2555 M: +91 7069553814Email: 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

ModelNumber	Model Name	Model Description
ALV002	alveoair DigitalSpirometer	Digital Spirometer to measure lung functionparameters

The alveoair Digital Spirometer system includes:

alveoair Digital Spirometer .

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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

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Comparison to predicate devices

Table 1: Comparison to Predicate Device

ComparableProperties	Subject Device	Predicate Device(K183089)	Reference Device(K072979)	ComparisonResults
Product name	alveoair DigitalSpirometer	Air Next	Spirobank G	Not applicable
Manufacturer	RoundworksTechnologies Pvt Ltd.	NuvoAir AB	M.I.R. MedicalInternationalResearch	Not applicable
ClassificationName	Spirometer, Diagnostic	Spirometer,Diagnostic	Spirometer,Diagnostic	Identical
Regulationnumber	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 DigitalSpirometer is intended toconduct basic lungfunction and spirometrytesting on patients aged≥ 22 years by healthcareprofessionals orclinicians in anyhealthcare environment.The alveoair DigitalSpirometer is notintended for use duringpatient transport.	Air Next is intendedto beused by:Healthcareprofessionalstrained to performspirometry tests onpatients of age ≥ 5years old, > 10 kg,and ≥ 110 cm.Air Next is intendedtoperform basic lungfunction andspirometry testing.	The Spirobank Gspirometer isintended to be usedby a physician orby a patient underthe instruction of aphysician orparamedic. Thedevice is intended totest lung function andcan make spirometrytesting in people ofall ages, excludinginfants and neonates.lt can be used in anysetting.	SubstantiallyEquivalent
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
ComparableProperties	Subject Device	Predicate Device(K183089)	Reference Device(K072979)	ComparisonResults
	clockwise, depends onthe flow direction.	interruption sensor.Thealgorithm in the	based on the infraredinterruptionprinciple.
	To measure therespiratory parametersaccurately, thespirometer's sensortracks the propeller'srotations and calculatesits spinning speedconcerning time. Thedevice's firmwareprocesses this data andcomputes a series ofvolume and flowcoordinates in liters persecond whenever aninterrupt data is receivedfrom the IR sensor.	firmware inside theAir Next device thenconverts the rotationsinto airflow measuredin liters persecond.The device is alsotestedagainst B.T.P.S.(bodytemperature andpressure withsaturated watervapor) conditions asprescribed byATS guidelines andthe results are wellwithin range	Spirometry testinterpretation isbased on the ForcedVital Capacity(FVC) test and isbased on the ATSstandard.
Technical Features
Flow Sensor	Bidirectional digitalturbine with infraredinterruption	Bidirectional turbinewithinfrared interruption	Bidirectional turbinewith infraredinterruption	Identical
Physical Characteristics
Size	112 x 55 x 21mm;	98 x 62 x 26mm	109 x 49 x 21mm	SubstantiallyEquivalent
Weight	Central unit 76g(including batteries)	75g	160g	SubstantiallyEquivalent
Energy Type	2 x 1.5V, AAA batteries	2 x 1.5V, AAAAlkaline	9V Alkaline battery	Identical toPredicate Device
ComparableProperties	Subject Device	Predicate Device(K183089)	Reference Device(K072979)	ComparisonResults
Display	The touchscreen onsmartphone ortablet	The touchscreen onsmartphone ortablet	Touchscreen / LCDand membrane	Identical toPredicate Device
OperatingEnvironment	Temp: MIN: +10°C,MAX: +40°CHumidity: MIN: 10% RH,MAX: 95% RH	Temp: MIN: +10°C,MAX: +40°CRH: 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 andaccuracy	Up to 8L±2.5% of reading or±0.050 L, whichever isgreater	Up to 10L±3% of reading or±0.050 L, whicheveris greater	Up to 10L±3% of reading or±0.050 L, whicheveris greater	Substantiallyequivalent as thesubject device iscompliant to therequirements ofAmerican ThoracicSociety (ATS)Standardization ofSpirometry 2019update and ISO26782: 2009
Flow range andaccuracy	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	Substantiallyequivalent as thesubject device iscompliant to therequirements ofISO 23747:2015
Flow resistance	<0.5 cmH2O/L/s	<0.5 cmH2O/L/s	<0.5 cmH2O/L/s	Identical
Connectivity	Bluetooth	Bluetooth	Bluetooth of USB	Identical
ComparableProperties	Subject Device	Predicate Device(K183089)	Reference Device(K072979)	ComparisonResults
IP Rating	IP22	IP32	IP22	Identical toReference Device
Turbine andMouthpiece	Single-use anddisposable	Single patient useand disposable	Single patient useand disposable	Identical
Material ofTurbine andMouthpiece	Polycarbonate and Purecellulose or paper	Polycarbonate andPure cellulose orpaper	unknown	Identical toPredicate Device
Shelf life	2 years	Unknown	Unknown	Substantiallyequivalent
Service Life	5 years	10 years	Around 10 years	Substantiallyequivalent
Measured Parameter
MeasuredParameters	FVC, FEV0.25, FEV0.5,FEV0.75, FEV1, FEV3,FEV6, FEV1/FVC,FEV0.5/ FVC,FEV3/FVC,FEV0.75/FVC, PEF,FEF2575, FEF10,FEF25, FEF40, FEF50,FEF60, FEF75, FEF80,FEF50/FVC,FEV1/FEV6, FET, BEV,FIVC, PIF, FIF25, FIF50,FIF75, and Estimated	FVC, FEV0.75,FEV1, FEV3, FEV6,FEV/FVC (FER) for0.75 /1/3 / 6, PEF,FEF25-75,FEF50/FVC,FEV1/FEV6, FET,FIVC, PIF, andFIF25-75 (MIF25-75)	FVC, FEV0.75,FEV1, FEV3, FEV6.FEV/FVC (FER) for0.75/1 /3 / 6, PEF,FEF25-75, FEF25,FEF50, FEF75,FEF50/FVC,FEV1/FEV6, FET,Evol, FIVC, PIF,FIF25-75 (MIF25-75),and ELA.	Similar parametersfor subject,predicate andreference devices.Differences donot affect the safeand effective use ofthe subjectdevice

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K222525

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Performance data

The alveoair digital spirometer complies with the following standards:

Electrical Safety and EMC:

1. 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).
1. 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.
1. 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:

1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
1. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes.

Cybersecurity:

1. 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) ●
1. ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
1. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.
1. ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices -Part 10: Tests for skin sensitization.
1. ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation.

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Risk Management:

1. ISO 14971:2019 Medical devices Application of risk management to medical devices.

Labels & IFU:

1. 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.
1. ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -Information to be supplied by the manufacturer.

Performance:

1. ISO 26782:2009 Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time-forced expired volumes in humans.
1. ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans.
1. ATS/ERS 2019 guideline Standardization of Spirometry 2019 Update an Official American Thoracic Society and European Respiratory Society Technical Statement.

Usability:

1. Guidance for Applying Human Factors and Usability Engineering to Medical Devices

Conclusion

All the above details collectively demonstrate that alveoair digital spirometer is substantially equivalent to the predicate device.

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).