Who is the manufacturer of EasyOne Sky Spirometer?

Ndd Medizintechnik AG filed the 510(k) submission for EasyOne Sky Spirometer (K230178).

What is the FDA product code for EasyOne Sky Spirometer?

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for EasyOne Sky Spirometer?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EasyOne Sky Spirometer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EasyOne Sky Spirometer

Q: What are the predicate devices for EasyOne Sky Spirometer?

EasyOne Air Spirometer (K161536).

K230178 · Ndd Medizintechnik AG · BZG · Oct 19, 2023 · Anesthesiology

Device Facts

Record ID	K230178
Device Name	EasyOne Sky Spirometer
Applicant	Ndd Medizintechnik AG
Product Code	BZG · Anesthesiology
Decision Date	Oct 19, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Intended 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 Story

EasyOne Sky (EOS) is a handheld, battery-powered diagnostic spirometer; utilizes ultrasonic transit-time measurement (TrueFlow Sensor FT) to acquire patient flow data; transmits data via Bluetooth Low Energy to a host mobile device running the EasyOne Mobile (EOMA) application. EOMA triggers measurements, communicates with the sensor, and visualizes data. Essential accessories include the single-patient-use EasyOne FlowTube (EOFT) and optional EasyOne Filter FT. Used by clinicians in hospitals, clinics, and occupational medicine to perform spirometry tests. Output includes flow-volume loops and various respiratory parameters (FVC, FEV1, etc.) displayed on the mobile device. Benefits include fast, accurate, and reliable pulmonary function assessment; supports clinical decision-making for respiratory conditions.

Clinical Evidence

Bench testing only. Performance validated against ATS/ERS/ISO 26782/23747 standards for accuracy, repeatability, and linearity. Biocompatibility evaluated per ISO 10993 and ISO 18562 series. Electrical safety and EMC testing per IEC 60601-1/1-2/1-6.

Technological Characteristics

Handheld, battery-powered (2x AA). Ultrasonic transit-time flow measurement. Bluetooth Low Energy connectivity. Dimensions: 111 x 84 x 33 mm. Weight: 140g. IP22 rating. Single-patient-use breathing tube (EasyOne FlowTube). Software: Firmware (MDSW) for sensor data acquisition; mobile application for visualization. Complies with IEC 60601-1, IEC 62304, and ISO 26782.

Indications for Use

Indicated for diagnostic spirometry testing in adults and pediatric patients aged 4 and older. Used by general practitioners, specialists, and healthcare professionals in hospitals, clinics, pharmacies, and occupational medicine settings.

Regulatory Classification

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.

Predicate Devices

EasyOne Air Spirometer (K161536)

Reference Devices

GoSpiro (K163249, K202837)

Related Devices

K161536 — EasyOne Air Spirometer · Ndd Medizintechnik AG · Jan 5, 2017
K150137 — SpiroThor · Cohero Health, LLC · May 27, 2015
K163249 — GoSpiro · Monitored Therapeutics, Inc. · Mar 24, 2017
K202837 — GoSpiro · Monitored Therapeutics, Inc. · Dec 4, 2020
K240293 — STS · Techbopulm, Ltd. · Sep 17, 2024

Submission Summary (Full Text)

{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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## 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 Technoparkstrasse 1 CH-8005 Zürich Note: NDD stands for New Diagnostic Design | | Official Contact | Andreas Senn Director Quality, RA & CA Ndd Medizintechnik AG, Switzerland Phone : +41 44 512 65 41 e-mail : ase@ndd.ch | | Alternative Contact | Roman Eicher Regulatory Affairs Manager & Safety Officer Ndd Medizintechnik AG, Switzerland Phone : +41 44 512 65 24 e-mail : rei@ndd.ch | | US agent | Robert Weisman NDD MEDICAL TECHNOLOGIES, INC. 300 Brickstone Sq Ste 604 ANDOVER, MA US 01810 Phone: 978 4700923 Ext 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 Subject Device | EasyOne Air Primary Predicate Device | Predicate comparison 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 testing | Diagnostic spirometry testing | Same | | | 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 | The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals | Substantially Equivalent | | | | | | | | | | Sky is used in hospitals, clinics, pharmacies, in clinical settings, and in occupational medicine. | and clinics, in pharmacies, and in clinical settings in occupational medicine. | | | | Type of use | Prescription use | Prescription use | Same | | | Patient population | Adults and pediatric patients over 4 years old | Adults and pediatric patients over 4 years old | Same | | | Users | General practitioners, specialists, healthcare professionals | General practitioners, specialists, healthcare professionals | Same | | | Use environment | Hospital and clinical settings Pharmacies Occupational medicine | Hospital and clinical settings Pharmacies Occupational medicine | Same | | | Single patient use | No. Accessories are for single patient use only | No. Accessories are for single patient use only | Same | | | Description | The EasyOne Sky spirometer is a hand-held battery powered device, which uses digital ultrasonic flow measurement technology for fast, accurate and reliable operation. The TrueFlow Sensor FT firmware performs the measurement and calculates the parameters in accordance with American Thoracic Society and European Respiratory Society requirements. The device transmits data to the EasyOne Mobile application over a Bluetooth connection to display the test results and further data management. | The EasyOne Air spirometer is a hand-held battery powered device, which uses digital ultrasonic flow measurement technology for fast, accurate and reliable operation. The EasyOne Air firmware performs the measurement and calculates the parameters in accordance with American Thoracic Society and European Respiratory Society requirements. The device has an integrated touchscreen to display the test results. Data can be transmitted to the EasyOne Connect PC Software via cradle or over a Bluetooth connection for further data management. | Similar | | | System components | Hand-held TrueFlow Sensor FT EasyOne Mobile application | Hand-held TrueFlow sensor with rechargeable battery Docking USB Cradle for charging and data transfer (EasyOne Connect Software) AC/DC power supply USB cables | Similar, both devices consist of a flow sensor and a software application to display and manage data. They differ in their power supply and other accessories. | | | Accessories for single patient use | Breathing Mouthpiece: EasyOne FlowTube | Breathing Mouthpiece: EasyOne FlowTube | Same | | | | Optional filter: EasyOne Filter FT | Optional filter: EasyOne Filter FT | | | | Software Requirements | Android, iOS Hard disk capacity minimum 250 MB | Embedded firmware | Similar software functionality but are different in implementation | | | Spirometry standards | Meets ATS/ERS/ISO waveform testing requirements | Meets ATS/ERS/ISO waveform testing requirements | Same | | | Forced expiratory vital capacity test (FVC) | FVC, FEV1, FEV0.75 (only shown for children ≤6yr), FEV1/FVC, FEV0.75/FVC (only shown for children ≤6yr), FET, PEF | FVC, FEV1, FEV0.75, FEV1/FV C, FEV0.75/FVC, FET, PEF | Same, Parameters for basic spirometry tests are the same 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/FV C, FEV0.75/FVC, PEF, FET, FIV C | Same | | | | Additional tests and parameters | 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, VCmax FVL 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, VCmax MVV additional parameter: MVV, MVV6, MVVtime, Rf, VCext, VT SVC additional parameter: ERV, IC, IRV, Rf, VC, VCex, VCin, VCmax, VT | Additional parameters which go beyond basic spirometry testing according ATS / ERS 2019 recommendation differ between devices. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Measurement principle | Ultrasonic transit-time measurement (TrueFlow) | Ultrasonic transit-time measurement (TrueFlow) | Same | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Measuring accuracy • Volume • Flow • Flow PEF | • ±2 % or 0.050L • ±2 % or 0.020L/s (except PEF)<br…