(269 days)
The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.
The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip.
Key functions:
- . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions.
- . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it.
- . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.
The EasyOne Sky spirometer, as described in the provided 510(k) summary, underwent various non-clinical tests to demonstrate its substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Performance | Complies with spirometry standards: ATS/ERS recommendation and guidelines, ISO 23747:2015 (Accuracy, Repeatability and Linearity) and ISO 26782:2009 (13 waveforms) | The device meets permissible margins given in ATS guidelines and ISO 26782. The parameters for basic spirometry tests are the same as defined in ATS/ERS 2019 Table 9. |
| Measurement Accuracy (Volume) | ±2% or 0.050L | Reported as conforming to this during comparison with predicate. |
| Measurement Accuracy (Flow, except PEF) | ±2% or 0.020L/s | Reported as conforming to this during comparison with predicate. |
| Measurement Accuracy (Flow PEF) | ±5% or 0.2L/s | Reported as conforming to this during comparison with predicate. |
| Cleaning, Disinfection | Cleaning & disinfection validation support that there is no loss of functionality. | Non-clinical testing demonstrated compliance (implied by "Non-clinical testing demonstrated that the proposed device is at least as safe and effective as the predicate"). |
| Biocompatibility | Biological Evaluation and toxicological risk assessment to evaluate device's biological safety for the intended use, in accordance with ISO 10993-series and FDA guidance. Specific endpoints considered (ISO 10993-18:2020 Physical and/or chemical information, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10:2021 Sensitization, ISO 10993-23:2021 Irritation or intracutaneous reactivity). Gas path testing according to ISO 18562-1:2017 (Biocompatibility evaluation), ISO 18562-2:2017 (Particulate matter emissions), ISO 18562-3:2017 (VOCs emissions). | The EasyOne FlowTube was introduced with K161536 and EasyOne Filter FT with K221250. Non-clinical testing demonstrated compliance for overall biocompatibility as per the general statement of safety and effectiveness. |
| Electrical Safety, Electromagnetic Compatibility | Complies with IEC 60601-1:2020 (General Requirements), IEC 60601-1-2:2020 (Electromagnetic Disturbances), IEC 60601-1-6:2020 CSV (Usability). | Non-clinical testing demonstrated compliance for overall safety and effectiveness. |
| Software, Cybersecurity | Software developed according to IEC 62304:2006 and IEC 82304-1:2016. FDA Guidance: Final Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005), Final Guidance Off-The-Shelf Software Use in Medical Devices (September 2019), Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014), Radio Frequency Wireless Technology in Medical Devices (August 2013). | Non-clinical testing demonstrated compliance for overall safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document specifies performance testing in accordance with ISO 26782:2009 for 13 waveforms. This refers to a standardized set of flow-volume and volume-time waveforms designed to test spirometer performance across a range of physiological conditions. The provenance of these waveforms is standardized and not patient-specific. The document does not specify additional clinical test set sizes or their provenance (e.g., country of origin, retrospective/prospective). The assessment relies heavily on compliance with recognized performance standards rather than a separate clinical test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the performance testing is established by international spirometry standards (ATS/ERS/ISO), which define the expected values for the 13 waveforms used in testing. These standards are developed by expert committees, but the document does not mention individual experts specifically establishing ground truth for this particular device's test set, as it relies on compliance with pre-defined standard waveforms.
4. Adjudication method for the test set
No specific adjudication method (like 2+1, 3+1) is mentioned for a test set. The evaluation is based on the device's technical performance against established international standards for spirometry.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader input for comparison.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was effectively done. The spirometer's core function is to measure and calculate spirometry parameters based on patient breathing. The "Performance" section explicitly states compliance with established spirometry standards (ATS/ERS/ISO), which are machine-based performance tests using standardized waveforms. The device's firmware performs the measurements and calculates parameters independently, and this is what was tested against international accuracy standards.
7. The type of ground truth used
The ground truth used for performance testing (accuracy, repeatability, linearity) is based on established spirometry standards and guidelines (ATS/ERS/ISO). Specifically, ISO 26782:2009 includes defined "reference waveforms" for evaluating spirometers, which serve as the ground truth against which the device's measurements are compared.
8. The sample size for the training set
The document does not provide information about a "training set" in the context of machine learning. The device is a traditional medical device that performs measurements and calculations based on physics (ultrasonic transit-time measurement) and programmed algorithms derived from clinical standards, not an AI/ML-based device that requires a training set of data.
9. How the ground truth for the training set was established
As there is no mention of a machine learning "training set," the concept of establishing ground truth for it is not applicable here.
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October 19, 2023
NDD Medizintechnik AG Andreas Senn Director Quality, RA & CA Technoparkstrasse 1 Zurich, 8005 Switzerland
Re: K230178
Trade/Device Name: EasyOne Sky Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: September 5, 2023 Received: September 6, 2023
Dear Andreas Senn:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
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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) K230178
Device Name EasyOne Sky spirometer
Indications for Use (Describe)
The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4.
The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals.
The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.
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
In accordance with 21 CFR 807.92 the following information is provided for EasyOne Sky spirometer.
ADMINISTRATIVE INFORMATION
| Date prepared | October 18, 2023 |
|---|---|
| Submission type: | Traditional 510(k) |
| Purpose of 510(k): | Introduction of a new device |
| Submitter | NDD Medizintechnik AGTechnoparkstrasse 1CH-8005 ZürichNote: NDD stands for New Diagnostic Design |
| Official Contact | Andreas SennDirector Quality, RA & CANdd Medizintechnik AG, SwitzerlandPhone : +41 44 512 65 41e-mail : ase@ndd.ch |
| Alternative Contact | Roman EicherRegulatory Affairs Manager & Safety OfficerNdd Medizintechnik AG, SwitzerlandPhone : +41 44 512 65 24e-mail : rei@ndd.ch |
| US agent | Robert WeismanNDD MEDICAL TECHNOLOGIES, INC.300 Brickstone Sq Ste 604ANDOVER, MA US 01810Phone: 978 4700923 ExtEmail: Rweisman@Nddmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade name: | EasyOne Sky Spirometer |
|---|---|
| Common name: | Diagnostic Spirometer |
| Regulation number: | 21 CFR 868.1840 |
| Classification name: | Diagnostic spirometer |
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| Regulatory class: | Class II |
|---|---|
| Product Code: | BZG |
PREDICATE DEVICE
| Primary Predicate Device: | EasyOne Air Spirometer, K161536 |
|---|---|
| Reference Devices: | GoSpiro, K163249, K202837 |
INDICATIONS FOR USE
The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinics, pharmacies, in clinical settings, and in occupational medicine.
DEVICE DESCRITION
The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip.
Key functions:
- . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions.
- . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it.
- . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.
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The host system, for example a smartphone, where EOMA runs on, is not part of the EOS medical electrical equipment.
Image /page/6/Picture/2 description: The image shows a spirometer and a smartphone displaying an app for tracking spirometry tests. The spirometer, labeled "EasyOne Sky", is held in a hand. The smartphone screen shows a list of activities, including spirometry tests from February 17th and 19th, with the app displaying the times of the tests.
Figure 1: Visualization of the EOS system including the TrueFlow sensor FT with the inserted EasyOne Flow Tube and the application EasyOne Mobile installed on a mobile device.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE
| Criteria | EasyOne SkySubject Device | EasyOne AirPrimary Predicate Device | Predicate comparisonresults | |
|---|---|---|---|---|
| 510(k) number | K230178 | K161536 | - | |
| Manufacturer | NDD Medizintechnik AG | NDD Medizintechnik AG | Same | |
| Regulation number | 21 CFR 868.1840 | 21 CFR 868.1840 | Same | |
| Classification name | Diagnostic Spirometer | Diagnostic Spirometer | Same | |
| Product Code(s) | BZG | BZG | Same | |
| Regulatory Class | II | Same | ||
| Intended use | Diagnostic spirometrytesting | Diagnostic spirometrytesting | Same | |
| Indications for use | The EasyOne Skyspirometer is intended toconduct diagnosticspirometry testing on adultsand pediatric patientsstarting at age 4. TheEasyOne Sky spirometer isused by generalpractitioners, specialistsand healthcareprofessionals. The EasyOne | The EasyOne Air spirometeris intended for prescriptionuse only to conductdiagnostic spirometrytesting of adults andpediatric patients over 4years old. The EasyOne Airspirometer is used bygeneral practitioners,specialists, and health careprofessionals, in hospitals | Substantially Equivalent | |
| Sky is used in hospitals,clinics, pharmacies, inclinical settings, and inoccupational medicine. | and clinics, in pharmacies,and in clinical settings inoccupational medicine. | |||
| Type of use | Prescription use | Prescription use | Same | |
| Patient population | Adults and pediatricpatients over 4 years old | Adults and pediatricpatients over 4 years old | Same | |
| Users | General practitioners,specialists, healthcareprofessionals | General practitioners,specialists, healthcareprofessionals | Same | |
| Use environment | Hospital and clinical settingsPharmaciesOccupational medicine | Hospital and clinicalsettingsPharmaciesOccupational medicine | Same | |
| Single patient use | No.Accessories are for singlepatient use only | No.Accessories are for singlepatient use only | Same | |
| Description | The EasyOne Skyspirometer is a hand-heldbattery powered device,which uses digital ultrasonicflow measurementtechnology for fast,accurate and reliableoperation. The TrueFlowSensor FT firmwareperforms the measurementand calculates theparameters in accordancewith American ThoracicSociety and EuropeanRespiratory Societyrequirements. The devicetransmits data to theEasyOne Mobile applicationover a Bluetoothconnection to display thetest results and further datamanagement. | The EasyOne Air spirometeris a hand-held batterypowered device, which usesdigital ultrasonic flowmeasurement technologyfor fast, accurate andreliable operation. TheEasyOne Air firmwareperforms the measurementand calculates theparameters in accordancewith American ThoracicSociety and EuropeanRespiratory Societyrequirements.The device has anintegrated touchscreen todisplay the test results. Datacan be transmitted to theEasyOne Connect PCSoftware via cradle or overa Bluetooth connection forfurther data management. | Similar | |
| System components | Hand-held TrueFlow SensorFTEasyOne Mobile application | Hand-held TrueFlow sensorwith rechargeable batteryDocking USB Cradle forcharging and data transfer(EasyOne ConnectSoftware)AC/DC power supplyUSB cables | Similar, both devices consistof a flow sensor and asoftware application todisplay and manage data.They differ in their powersupply and otheraccessories. | |
| Accessories for singlepatient use | Breathing Mouthpiece:EasyOne FlowTube | Breathing Mouthpiece:EasyOne FlowTube | Same | |
| Optional filter: EasyOneFilter FT | Optional filter: EasyOneFilter FT | |||
| SoftwareRequirements | Android, iOSHard disk capacity minimum250 MB | Embedded firmware | Similar softwarefunctionality but aredifferent in implementation | |
| Spirometry standards | Meets ATS/ERS/ISOwaveform testingrequirements | Meets ATS/ERS/ISOwaveform testingrequirements | Same | |
| Forced expiratory vitalcapacity test (FVC) | FVC, FEV1, FEV0.75 (onlyshown for children ≤6yr),FEV1/FVC, FEV0.75/FVC(only shown for children≤6yr), FET, PEF | FVC, FEV1, FEV0.75, FEV1/FVC, FEV0.75/FVC, FET, PEF | Same, Parameters for basicspirometry tests are thesame as defined in ATS /ERS 2019 Table 9. | |
| Flow volume loop test(FVL) | FVC, FEV1, FEV0.75,FEV1/FVC, FEV0.75/FVC,PEF, FET, FIVC | FVC, FEV1, FEV0.75, FEV1/FVC, FEV0.75/FVC, PEF, FET, FIVC | Same | |
| Additional tests andparameters | FVC: additional parameter:- FEF25-75, FEF25, FEF50,FEF75- MMEF, MEF75, MEF50,MEF25, (naming)FVL additional parameter:- PIF- FEF25-75, FEF25, FEF50,FEF75- MMEF, MEF75, MEF50,MEF25, (naming) | FVC additional parameter:ATI, BEV, EOTV, FEF10,FEF25, FEF25-75, FEF25-75_6, FEF40, FEF50,FEF50/FVC, FEF50/VCmax,FEF60, FEF75, FEF75-85,FEF80, FET25-75, FEV.25,FEV.5,FEV.5/FVC, FEV.75/FEV6,FEV.75/VCmax,FEV1/FEV6, FEV1/FVC6,FEV1/VC, FEV1/VCmax,FEV3/FVC, FEV3/VCmax,FEV3, FEV6, FVC, MEF20,MEF25, MEF40,MEF50, MEF60, MEF75,MEF90, MMEF, MTC1,MTC2, MTC3, MTCR,PEFT, t₀, VC, VCmaxFVL additional parameter:ATI, BEV, CVI, E50/150,EOTV, FEF10, FEF25, FEF25-75, FEF25-75_6,FEF40, FEF50, FEF50/FVC,FEF50/VCmax, FEF60,FEF75, FEF75-85,FEF80, FET25-75, FEV.25,FEV.5, FEV.5/FVC,FEV.75/FEV6,FEV.75/VCmax, FEV1/FEV6,FEV1/FIV1,FEV1/FIVC,FEV1/VC, FEV1/VCmax,FEV3/FVC,FEV3/VCmax,FEV3, FEV6, FIF25, FIF 25-75, FIF50,FIF50/FEF50, FIF75, FIV.25,FIV.5, FIV1, MEF20, MEF25,MEF40, MEF50, MEF60,MEF75, MEF90, MIF25,MIF50, MIF75,MMEF, MMIF, MTC1,MTC2, MTC3, MTCR, PEFT,PIF, t₀, VC,VCmaxMVV additional parameter:MVV, MVV6, MVVtime, Rf,VCext, VTSVC additional parameter:ERV, IC, IRV, Rf, VC, VCex,VCin, VCmax, VT | Additional parameterswhich go beyond basicspirometry testingaccording ATS / ERS 2019recommendation differbetween devices. |
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| Measurementprinciple | Ultrasonic transit-timemeasurement (TrueFlow) | Ultrasonic transit-timemeasurement (TrueFlow) | Same |
|---|---|---|---|
| Measuring accuracy• Volume• Flow• Flow PEF | • ±2 % or 0.050L• ±2 % or 0.020L/s(except PEF)• ±5% or 0.2L/s | • ±2 % or 0.050L• ±2 % or 0.020L/s(except PEF)• ±5% or 0.2L/s | Same |
| Measuring range• Volume• Flow | 0 - 8 L±16 L/s | 0 - 12 L±16 L/s | The ranges of the subjectdevice meet permissiblemargins given in ATSguidelines and ISO 26782. |
| Resolution | 1 mL/s | 1 mL/s | Same |
| Resistance | Less than 1.5 cm H2O/L/s at16L/s | Less than 1.5 cm H2O/L/s at16L/s | Same |
| Dimensions L x H x B | 111 × 84 × 33 mm | 155 × 87 × 36 mm(6.1 x 3.4 x 1.4 in) | Similar |
| Weight | 140 g without batteries | 302 g (11 oz) withoutbattery356 g (13 oz) with battery | EasyOne Sky is smaller inweight |
| Display | No integrated display, datadisplayed on mobile device | Integrated LCD touchscreen88.9 mm (3.5 in) diagonalsize320 x 240 pixels | Substantially Equivalent |
| Power supply | 2x AA size alkaline batteries | Rechargeable lithium-ionbattery(output 3.6 V)AC/DC power supply forcharging(4.5 to 5,5 V) | Similar |
| Voltage | 5V DC | 4.5 V to 5.5 V | Similar |
| Power consumption | 0.3 W | Up to 7.5 W | Similar |
| IP code | IP22 | IP20 | Similar |
| Hardware interface | None | USB 1.0/1.1, USB 2.0 (max.100 mA) | Different |
| Wireless connection | Bluetooth Low Energy• Frequency range 2.4GHz ISM band(2.402 – 2.480 GHzutilized)Modulation GFSK(Gaussian frequencyshift keying)• Output power -4 dBm | Bluetooth Low Energy• Frequency range 2.402GHz to 2.480 GHzModulation GFSK,DQPSK, 8DPSKOutput power 15 dBmQoS WMM and WMMPower Save Support | Same |
| Data management | EasyOne Mobile application | EasyOne Connect PCsoftware | Similar, devices managetheir acquired data with aseparate data managementsoftware. |
| Export / ElectronicMedical Records(EMR) | HL7, XML, GDT | HL7, XML, GDT | Same |
| Printing option | Yes, over network | Direct to printer or withEasyOne Connect PCsoftware | Similar, different printeroptions |
| Lifetime | 7 years | 7 years | Same |
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The subject device EasyOne Sky has similar intended use, target populations, technological characteristics, and materials as the predicate device EasyOne Air and reference device GoSpiro. The subject and the predicate device have the same fundamental design, use the same TrueFlow ultrasound measurement principle to and same EasyOne FlowTube breathing mouthpiece and optional EasyOne Filter FT accessories. The spirometer itself is reusable whereby accessories are single use devices and intended for single patient use only.
EasyOne Sky, EasyOne Air and GoSpiro spirometers all provide basic spirometry testing in accordance with ATS / ERS recommendations and guidelines.
The hand-held sensors TrueFlow Sensor FT and GoSpiro do not have a built-in display, they all require a separate device for displaying results. The EasyOne Sky and the GoSpiro are using an application for displaying data or graphics.
Any differences between EasyOne Sky and the predicate EasyOne Air do not raise questions concerning safety and effectiveness. Performance testing in accordance with applicable standards demonstrates that the EasyOne Sky is adequate for its intended use. The EasyOne Sky spirometer is therefore substantially equivalent to the predicate.
| Test | Acceptance Criteria |
|---|---|
| Performance | Complies with spirometry standardsATS/ERS recommendation and guidelines,ISO 23747:2015 (Accuracy, Repeatability and Linearity) and ISO26782:2009 (13 waveforms) |
| Cleaning, disinfection | Cleaning & disinfection validation support that there is no loss offunctionality. |
| Biocompatibility | Biological Evaluation and toxicological risk assessment to evaluate device'sbiological safety for the intended use, in accordance with ISO 10993-series and FDA guidance.The EasyOne FlowTube and EasyOne Filter FT are in the breathing gaspathway. The EasyOne FlowTube has been introduced with K161536 andEasyOne Filter FT with K221250. |
| Contact type: | Intact skin for TrueFlow Sensor FT Intact skin, mucosa, and externally communicating tissue/bone/dentin device for EasyOne FlowTube |
| Contact duration: | Prolonged |
| Considered endpoints per ISO 10993-1:2018 | ISO 10993-18:2020 Physical and/or chemical information ISO 10993-5:2009 Cytotoxicity ISO 10993-10:2021 Sensitization ISO 10993-23:2021 Irritation or intracutaneous reactivity |
| Gas path testing according to | ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways ISO 18562-2:2017 Tests for emissions of particulate matter ISO 18562-3:2017 Tests for emissions of volatile organic compounds (VOCs) |
| Electrical Safety, Electromagnetic Compatibility | Complies with IEC 60601-1:2020 General Requirements for Basic Safety And Essential Performance IEC 60601-1-2: 2020 Electromagnetic Disturbances IEC 60601-1-6:2020 CSV Usability |
| Software, Cybersecurity | Software developed according to IEC 62304:2006 and IEC 82304-1:2016 Final Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 Final Guidance Off-The-Shelf Software Use in Medical Devices, September 2019 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2014 Radio Frequency Wireless Technology in Medical Devices, August 2013 |
SUMMARY OF NON-CLINICAL TESTS
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CONCLUSION
The subject device EasyOne Sky has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the proposed device is at least as safe and effective as the predicate. Therefore the subject device is substantially equivalent to the predicate device.
§ 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).