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510(k) Data Aggregation
(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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