(269 days)
No
The document describes a standard spirometer that measures airflow using an ultrasonic sensor and transmits data wirelessly. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The functions described are data acquisition, communication, and visualization.
No
The device is described as being intended "to conduct diagnostic spirometry testing," which means it is used to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing".
No
The device description explicitly states it consists of hardware components (TrueFlow Sensor FT, EasyOne FlowTube) in addition to the software application.
Based on the provided information, the EasyOne Sky spirometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The EasyOne Sky spirometer measures airflow directly from the patient's breath. It does not analyze blood, urine, tissue, or any other bodily fluid or sample.
- The intended use and device description clearly indicate direct patient measurement. The device measures air flow during breathing maneuvers performed by the patient.
- The device description focuses on measuring physical parameters (airflow) rather than analyzing biological or chemical components of a sample.
Therefore, the EasyOne Sky spirometer falls under the category of a medical device used for diagnostic purposes, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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, clinical settings, and in occupational medicine.
Product codes
BZG
Device Description
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 host system, for example a smartphone, where EOMA runs on, is not part of the EOS medical electrical equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric patients starting at age 4
Intended User / Care Setting
Used by general practitioners, specialists and healthcare professionals.
Used in hospitals, clinical settings, and in occupational medicine.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance: Complies with spirometry standards ATS/ERS recommendation and guidelines, ISO 23747:2015 (Accuracy, Repeatability and Linearity) and ISO 26782:2009 (13 waveforms)
Cleaning, disinfection: Cleaning & disinfection validation support that there is no loss of functionality.
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. The EasyOne FlowTube and EasyOne Filter FT are in the breathing gas pathway. The EasyOne FlowTube has been introduced with K161536 and EasyOne 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
Key Metrics
Not Found
Predicate Device(s)
EasyOne Air Spirometer, K161536
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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)
• ±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 subject
device meet permissible
margins given in ATS
guidelines and ISO 26782. |
| Resolution | 1 mL/s | 1 mL/s | Same |
| Resistance | Less than 1.5 cm H2O/L/s at
16L/s | Less than 1.5 cm H2O/L/s at
16L/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) without
battery
356 g (13 oz) with battery | EasyOne Sky is smaller in
weight |
| Display | No integrated display, data
displayed on mobile device | Integrated LCD touchscreen
88.9 mm (3.5 in) diagonal
size
320 x 240 pixels | Substantially Equivalent |
| Power supply | 2x AA size alkaline batteries | Rechargeable lithium-ion
battery
(output 3.6 V)
AC/DC power supply for
charging
(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 2.4
GHz ISM band
(2.402 – 2.480 GHz
utilized)
Modulation GFSK
(Gaussian frequency
shift keying)
• Output power -4 dBm | Bluetooth Low Energy
• Frequency range 2.402
GHz to 2.480 GHz
Modulation GFSK,
DQPSK, 8DPSK
Output power 15 dBm
QoS WMM and WMM
Power Save Support | Same |
| Data management | EasyOne Mobile application | EasyOne Connect PC
software | Similar, devices manage
their acquired data with a
separate data management
software. |
| Export / Electronic
Medical Records
(EMR) | HL7, XML, GDT | HL7, XML, GDT | Same |
| Printing option | Yes, over network | Direct to printer or with
EasyOne Connect PC
software | Similar, different printer
options |
| Lifetime | 7 years | 7 years | Same |
11
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 standards |
| ATS/ERS recommendation and guidelines, | |
| ISO 23747:2015 (Accuracy, Repeatability and Linearity) and ISO | |
| 26782:2009 (13 waveforms) | |
| Cleaning, disinfection | Cleaning & disinfection validation support that there is no loss of |
| functionality. | |
| 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. | |
| The EasyOne FlowTube and EasyOne Filter FT are in the breathing gas | |
| pathway. The EasyOne FlowTube has been introduced with K161536 and | |
| EasyOne 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.