(209 days)
To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.
The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients. All variants {asma-1 and copd-6} within the range use the very same operating principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only. A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD. Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}
Here's an analysis of the provided text to extract information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Feature | Acceptance Criteria (Vitalograph Model 4000) | Reported Device Performance (Vitalograph Model 4000) |
|---|---|---|
| Volume Range | 0-9.99 Litres | Meets: 0-9.99 Litres |
| Flow Range | 0-840 L/minute | Meets: 0-840 L/minute |
| Accuracy FEV1 | +/- 3% | Meets: +/- 3% |
| Accuracy FEV6 | +/- 3% | Meets: +/- 3% |
| Accuracy PEF | +/- 5% | Meets: +/- 5% |
| Back Pressure | Better than 0.15kPa/L/s at 14L/s | Meets: Better than 0.15kPa/L/s at 14L/s |
| Operating Temp | 17-37°C per ATS 2005 | Meets: 17-37°C per ATS 2005 |
| Storage Temp | 0 - 50 °C | Meets: 0 - 50 °C |
| Humidity | 10 - 95% relative humidity | Meets: 10 - 95% relative humidity |
| Standard | ATS 2005, ISO 23747:2007 for PEF (formerly EN13826:2003) | Meets: ATS 2005, ISO 23747:2007 for PEF (formerly EN13826:2003) |
| Compliance | EN 60601 (EN 60601-1-1 and EN 60601-1-2), IEC 61000-4-2, IEC61000-4-3 (battery operated) | Meets: EN 60601 (EN 60601-1-1 and EN 60601-1-2), IEC 61000-4-2, IEC61000-4-3 (battery operated) |
| Regulatory | FDA - 510(k), CE (0086) Class 2a | Meets: FDA - 510(k), CE (0086) Class 2a |
| Lung Age Display | ASMA-1: NO, COPD-6: Yes (This is a feature comparison to the predicate, not strictly an acceptance criterion, but included for completeness as it differentiates the models) | Meets: ASMA-1: NO, COPD-6: Yes |
| Set Predicted / | ||
| reference values | Yes (by qualified person, not user) (This is a feature comparison to the predicate, not strictly an acceptance criterion, but included for completeness) | Meets: Yes (by qualified person, not user) |
| Communication | Bluetooth and/or USB to be incorporated. (This describes the intended feature, and its functionality would need to be verified during testing). | Meets: Bluetooth and/or USB to be incorporated. (The approval implies this was considered functional, though specific performance details for this are not in the table). |
| Battery Warnings | On-screen Battery Full, Half Full and Battery Empty (Flashing icon) (This describes the intended feature, and its functionality would need to be verified during testing). | Meets: On-screen Battery Full, Half Full and Battery Empty (Flashing icon). |
| Autopowerdown | 2 minutes (This is a design specification, and its functionality would need to be verified during testing). | Meets: 2 minutes. |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study for novel device performance. The acceptance criteria are primarily based on established international standards for spirometers (ATS 2005, ISO 23747:2007) and regulatory compliance (EN 60601 series, IEC 61000 series, FDA 510(k), CE marking).
The statement "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices" implies that Vitalograph submitted data demonstrating that their device meets these established performance and safety standards. However, the 510(k) summary itself does not explicitly detail the study or studies that generated the performance data (e.g., how the +/- 3% accuracy was verified). Instead, it states the specifications and that the device meets them, likely supported by internal testing reports that are part of the larger 510(k) submission, but not included in this summary.
Given the nature of a spirometer, the "study" would likely involve:
- Bench testing: Using calibrated flow and volume generators to assess the accuracy of FEV1, FEV6, and PEF measurements across the specified ranges.
- Environmental testing: Subjecting the device to various temperature and humidity conditions to verify operating and storage parameters.
- Electromagnetic Compatibility (EMC) testing: Conforming to IEC 61000 standards.
- Safety testing: Conforming to EN 60601 standards for medical electrical equipment.
Detailed Information Not Available in the Provided Text:
The document is a 510(k) summary, which often omits the granular details of testing methodologies and underlying data. Therefore, the following information is not provided in the extracted text:
- Sample size used for the test set and the data provenance: Not specified. The performance metrics (e.g., accuracy) are stated as specifications rather than results from a particular test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. For spirometer accuracy, ground truth is typically established by physical standards and calibrated equipment, not by human expert consensus or annotations in the way AI/radiology devices might.
- Adjudication method for the test set: Not applicable/specified, as the ground truth is based on physical standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone diagnostic spirometer, not an AI-assisted diagnostic tool that helps human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the performance metrics listed (e.g., accuracy for FEV1, FEV6, PEF) would be derived from the device's inherent measurement capabilities operating in a standalone mode, without human interpretation for the measurement itself (though human interpretation of the results is part of its intended use).
- The type of ground truth used: For accuracy measurements (FEV1, FEV6, PEF), the ground truth would be established by calibrated spirometer verification equipment (e.g., a syringe pump or flow/volume simulator) that can deliver known volumes and flows.
- The sample size for the training set: Not applicable. This device is a measurement instrument, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set for this type of 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).