(220 days)
The device is a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.
The Vitalograph Model 2120 is intended to be used, as its predecessor, as a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.
The Model 2120 series has been available to the marketplace for over 15 years {ref K946075}. This device is a hand held electronic Spirometer, used in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. Spirometry. This revised design is an upgrade to the existing product in terms of modernising its look and feel {i.e. changes to ergonomics and user interface}. The intended uses and operating principles in relation to its measurement of respiratory function remain unchanged.
Its primary functions are:
- Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including FVC, VC, MVV) and it's subdivisions,
- Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac {see K912412}.
- The flowhead will be a Fleisch Pneumotachograph type flowhead, the operating principle of which has been well established in the existing Model 2120 {K946075} and various other spirometers. {e.g. Vitalograph Compact Ref K854526. Vitalograph Alpha ref K873562, Vitalograph Escort K925085}
All variants of the Model 2120 {e.g. including In2itive, e-Diary} will use very same operating principle, LCD, Buttons, optional Touchscreen, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display.
Navigation is allowed via the use of five buttons {Up, Down, Enter/Select, Cancel /Esc and power On/Off} or an optional touch screen.
Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 2120 Hand Held Spirometer, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Vitalograph Model 2120 Specifications) | Reported Device Performance (Vitalograph Model 2120 Specifications) |
|---|---|---|
| Volume Range | 0-10 Litres | 0-10 Litres |
| Max Flow Range | 0-16 Litres/second | 0-16 Litres/second |
| Back Pressure | Less than 0.1kPa/L/s | Less than 0.1kPa/L/s |
| Accuracy FEV1 | +/- 3% | +/- 3% |
| Accuracy FEV6 | +/- 3% | +/- 3% |
| Accuracy PEF | +/- 5% | +/- 5% |
| Operating Temp | 10-40°C. (At least 17-37°C required per ATS 2005) | 10-40°C (At least 17-37°C required per ATS 2005) |
| Storage Temp | 0 - 50 °C | 0 - 50 °C |
| Humidity | 10 - 95% relative humidity | 10 - 95% relative humidity |
| Performance Standards | ATS ERS 2005, ISO 23747:2007 for PEF, EN ISO 26782:2009 | ATS ERS 2005, ISO 23747:2007 for PEF, EN ISO 26782:2009 |
Study Proving Device Meets Acceptance Criteria:
The document states that "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing to American Thoracic Society (ATS) and International Organisation for Standardisation (ISO) standards."
The specific standards referenced for performance are:
- ATS ERS 2005
- ISO 23747:2007 for PEF (formerly EN13826:2003)
- EN ISO 26782:2009
The table above demonstrates that the device's specifications meet the listed accuracy and range requirements, indicating compliance with these standards. The conclusion explicitly states, "Based on the above, including the successful completion of all device testing, Vitalograph conclude that this device is substantially equivalent to the legally marketed predicate devices and is safe and effective for use."
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "extensive testing" but does not provide details on the testing methodology, number of subjects, or type of data used (patient data vs. simulated data). Given this is a spirometer, testing would typically involve controlled laboratory simulations with known volumes/flows and potentially human subjects, but these details are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. For device performance testing of a spirometer, ground truth is typically established by physical reference standards (e.g., calibrated syringes) rather than expert consensus on patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth for a spirometer's performance is typically based on objective physical measurements and not on expert adjudication of subjective findings. The document does not describe any such adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human interpretation is a key component and the AI assists human readers. For a spirometer that directly measures physical parameters, an MRMC study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
Yes, implicitly. The device itself is a "standalone" spirometer designed to produce measurements directly. The performance testing "to American Thoracic Society (ATS) and International Organisation for Standardisation (ISO) standards" inherently assesses the algorithm's ability to accurately measure respiratory parameters without human interpretation in the loop. The device directly calculates and displays the FVC, MVV, and VC parameters.
7. The Type of Ground Truth Used
The ground truth used for validating the spirometer's performance would primarily be physical reference standards (e.g., highly accurate, calibrated syringes that deliver precise volumes and flows). The device's "Calibration" method is listed as "Using calibration syringe," which supports this. These standards are used to input known volumes and flows into the device, and its measured output is compared against these known values to determine accuracy.
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning is not applicable to this device. The Vitalograph Model 2120 is a rule-based or physics-based measurement device, using a Fleisch Pneumotachograph and established algorithms ("Same algorithm for spirometry parameters calculation"). It does not describe an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" in the context of AI/ML is not applicable to this 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).