EasyOne Sky Spirometer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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" {1}------------------------------------------------ (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 {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # 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) | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 AG<br>Technoparkstrasse 1<br>CH-8005 Zürich<br>Note: NDD stands for New Diagnostic Design | | Official Contact | Andreas Senn<br>Director Quality, RA & CA<br>Ndd Medizintechnik AG, Switzerland<br>Phone : +41 44 512 65 41<br>e-mail : ase@ndd.ch | | Alternative Contact | Roman Eicher<br>Regulatory Affairs Manager & Safety Officer<br>Ndd Medizintechnik AG, Switzerland<br>Phone : +41 44 512 65 24<br>e-mail : rei@ndd.ch | | US agent | Robert Weisman<br>NDD MEDICAL TECHNOLOGIES, INC.<br>300 Brickstone Sq Ste 604<br>ANDOVER, MA US 01810<br>Phone: 978 4700923 Ext<br>Email: 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 | {5}------------------------------------------------ | 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. {6}------------------------------------------------ ## 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 Sky<br>Subject Device | EasyOne Air<br>Primary Predicate Device | Predicate comparison<br>results | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | 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 spirometry<br>testing | Diagnostic spirometry<br>testing | Same | | | Indications for use | The EasyOne Sky<br>spirometer is intended to<br>conduct diagnostic<br>spirometry testing on adults<br>and pediatric patients<br>starting at age 4. The<br>EasyOne Sky spirometer is<br>used by general<br>practitioners, specialists<br>and healthcare<br>professionals. The EasyOne | The EasyOne Air spirometer<br>is intended for prescription<br>use only to conduct<br>diagnostic spirometry<br>testing of adults and<br>pediatric patients over 4<br>years old. The EasyOne Air<br>spirometer is used by<br>general practitioners,<br>specialists, and health care<br>professionals, in hospitals | Substantially Equivalent | | | | | | | | | | Sky is used in hospitals,<br>clinics, pharmacies, in<br>clinical settings, and in<br>occupational medicine. | and clinics, in pharmacies,<br>and in clinical settings in<br>occupational medicine. | | | | Type of use | Prescription use | Prescription use | Same | | | Patient population | Adults and pediatric<br>patients over 4 years old | Adults and pediatric<br>patients over 4 years old | Same | | | Users | General practitioners,<br>specialists, healthcare<br>professionals | General practitioners,<br>specialists, healthcare<br>professionals | Same | | | Use environment | Hospital and clinical settings<br>Pharmacies<br>Occupational medicine | Hospital and clinical<br>settings<br>Pharmacies<br>Occupational medicine | Same | | | Single patient use | No.<br>Accessories are for single<br>patient use only | No.<br>Accessories are for single<br>patient use only | Same | | | Description | The EasyOne Sky<br>spirometer is a hand-held<br>battery powered device,<br>which uses digital ultrasonic<br>flow measurement<br>technology for fast,<br>accurate and reliable<br>operation. The TrueFlow<br>Sensor FT firmware<br>performs the measurement<br>and calculates the<br>parameters in accordance<br>with American Thoracic<br>Society and European<br>Respiratory Society<br>requirements. The device<br>transmits data to the<br>EasyOne Mobile application<br>over a Bluetooth<br>connection to display the<br>test results and further data<br>management. | The EasyOne Air spirometer<br>is a hand-held battery<br>powered device, which uses<br>digital ultrasonic flow<br>measurement technology<br>for fast, accurate and<br>reliable operation. The<br>EasyOne Air firmware<br>performs the measurement<br>and calculates the<br>parameters in accordance<br>with American Thoracic<br>Society and European<br>Respiratory Society<br>requirements.<br>The device has an<br>integrated touchscreen to<br>display the test results. Data<br>can be transmitted to the<br>EasyOne Connect PC<br>Software via cradle or over<br>a Bluetooth connection for<br>further data management. | Similar | | | System components | Hand-held TrueFlow Sensor<br>FT<br>EasyOne Mobile application | Hand-held TrueFlow sensor<br>with rechargeable battery<br>Docking USB Cradle for<br>charging and data transfer<br>(EasyOne Connect<br>Software)<br>AC/DC power supply<br>USB cables | Similar, both devices consist<br>of a flow sensor and a<br>software application to<br>display and manage data.<br>They differ in their power<br>supply and other<br>accessories. | | | Accessories for single<br>patient use | Breathing Mouthpiece:<br>EasyOne FlowTube | Breathing Mouthpiece:<br>EasyOne FlowTube | Same | | | | Optional filter: EasyOne<br>Filter FT | Optional filter: EasyOne<br>Filter FT | | | | Software<br>Requirements | Android, iOS<br>Hard disk capacity minimum<br>250 MB | Embedded firmware | Similar software<br>functionality but are<br>different in implementation | | | Spirometry standards | Meets ATS/ERS/ISO<br>waveform testing<br>requirements | Meets ATS/ERS/ISO<br>waveform testing<br>requirements | Same | | | Forced expiratory vital<br>capacity test (FVC) | FVC, FEV1, FEV0.75 (only<br>shown for children ≤6yr),<br>FEV1/FVC, FEV0.75/FVC<br>(only shown for children<br>≤6yr), FET, PEF | FVC, FEV1, FEV0.75, FEV1/FV<br>C, FEV0.75/FVC, FET, PEF | Same, Parameters for basic<br>spirometry tests are the<br>same as defined in ATS /<br>ERS 2019 Table 9. | | | Flow volume loop test<br>(FVL) | FVC, FEV1, FEV0.75,<br>FEV1/FVC, FEV0.75/FVC,<br>PEF, FET, FIVC | FVC, FEV1, FEV0.75, FEV1/FV<br>C, FEV0.75/FVC, PEF, FET, FIV<br>C | Same | | | | Additional tests and<br>parameters | FVC: additional parameter:<br>- FEF25-75, FEF25, FEF50,<br>FEF75<br>- MMEF, MEF75, MEF50,<br>MEF25, (naming)<br>FVL additional parameter:<br>- PIF<br>- FEF25-75, FEF25, FEF50,<br>FEF75<br>- MMEF, MEF75, MEF50,<br>MEF25, (naming) | FVC additional parameter:<br>ATI, BEV, EOTV, FEF10,<br>FEF25, FEF25-75, FEF25-<br>75_6, FEF40, FEF50,<br>FEF50/FVC, FEF50/VCmax,<br>FEF60, FEF75, FEF75-85,<br>FEF80, FET25-75, FEV.25,<br>FEV.5,<br>FEV.5/FVC, FEV.75/FEV6,<br>FEV.75/VCmax,<br>FEV1/FEV6, FEV1/FVC6,<br>FEV1/VC, FEV1/VCmax,<br>FEV3/FVC, FEV3/VCmax,<br>FEV3, FEV6, FVC, MEF20,<br>MEF25, MEF40,<br>MEF50, MEF60, MEF75,<br>MEF90, MMEF, MTC1,<br>MTC2, MTC3, MTCR,<br>PEFT, t₀, VC, VCmax<br>FVL additional parameter:<br>ATI, BEV, CVI, E50/150,<br>EOTV, FEF10, FEF25, FEF25-<br>75, FEF25-75_6,<br>FEF40, FEF50, FEF50/FVC,<br>FEF50/VCmax, FEF60,<br>FEF75, FEF75-85,<br>FEF80, FET25-75, FEV.25,<br>FEV.5, FEV.5/FVC,<br>FEV.75/FEV6,<br>FEV.75/VCmax, FEV1/FEV6,<br>FEV1/FIV1,FEV1/FIVC,<br>FEV1/VC, FEV1/VCmax,<br>FEV3/FVC,FEV3/VCmax,<br>FEV3, FEV6, FIF25, FIF 25-<br>75, FIF50,<br>FIF50/FEF50, FIF75, FIV.25,<br>FIV.5, FIV1, MEF20, MEF25,<br>MEF40, MEF50, MEF60,<br>MEF75, MEF90, MIF25,<br>MIF50, MIF75,<br>MMEF, MMIF, MTC1,<br>MTC2, MTC3, MTCR, PEFT,<br>PIF, t₀, VC,<br>VCmax<br>MVV additional parameter:<br>MVV, MVV6, MVVtime, Rf,<br>VCext, VT<br>SVC additional parameter:<br>ERV, IC, IRV, Rf, VC, VCex,<br>VCin, VCmax, VT | Additional parameters<br>which go beyond basic<br>spirometry testing<br>according ATS / ERS 2019<br>recommendation differ<br>between devices. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Measurement<br>principle | Ultrasonic transit-time<br>measurement (TrueFlow) | Ultrasonic transit-time<br>measurement (TrueFlow) | Same | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Measuring accuracy<br>• Volume<br>• Flow<br>• Flow PEF | • ±2 % or 0.050L<br>• ±2 % or 0.020L/s<br>(except PEF)<br…