(177 days)
The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatic and addlt patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.
The Micro I spirometer is a hand held portable microprocessor based device designed to measure expiratory flows and volumes. To perform a spirometry test the user first inserts a mouthpiece into the mouthpiece holder of the spirometer, which aligns it with the volume transducer. The unit is then turned on and displays instructions and prompts according to the device type. When prompted to do so by the operator, the patient inhales as deeply as possible, seals his/her lips around the mouthpiece and exhales as hard and as fast as possible until no more air can be exhaled. The device converts the airflow to an electrical signal, and the onboard software calculates the required values.
Here's an analysis of the acceptance criteria and study information for the Micro I spirometer, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Predicate: MicroLab K031102 & Micro Diary K100928/ATS/ERS) | Reported Device Performance (Micro I K113096) |
|---|---|---|
| Indications for Use | Measure maximal volume and flow of air for pulmonary function testing. (Microlab: prescription use, pediatric (4-17), adult (18-99). Micro Diary: measures FEV1, FVC, FEV6, PEF). | Measures maximal volume and flow of air moved out of patient's lungs. For pediatric and adult patients over 3 years in hospitals, physician offices, laboratories, and occupational health. |
| Target Population | Pediatric (4-17 years), Adult (18-99 years) for Microlab. 4 years and older for Micro Diary. | Over the age of 3 years. |
| Performance Specifications (Measurements) | MicroLab: VC, FEV1, FEV3, FEV6, FVC, PEF, FEV1/FVC, etc. Micro Diary: FEV1, FVC, FEV6, PEF. | FEV1, FVC, FEV6, FEV1/FVC, FEV1/FEV6, PEF, FEF25, FEF75, FEF25-75. |
| Transducer Material (Breathing Path Contacting) | MicroLab/Micro Diary: Turbine swirl plate (Polycarbonate/Makrolon 2607), Turbine van (Polyester type 427), Turbine tube (Clear Acrylic/Makrolon 2607), Pivot (Nivapoint stainless steel). | Identical to K100928 (Micro Diary). |
| Transducer Type | MicroLab: Type 36-TDX 1048 CareFusion Bi-Directional Digital Volume. Micro Diary: Type 36-TDX 1050 CareFusion Uni-Directional Digital Volume. | Type 36-TDX 1051 CareFusion Uni-Directional Digital Volume. |
| Resolution | 0.01 liter. | Identical to K100928 & K031102. |
| Accuracy (FEV1/FVC/PEF) | +/- 3% to ATS Recommendations (MicroLab). To the requirements of the ATS/ERS Taskforce: Standardization of Spirometry 2005 (Micro Diary). | Identical to K100928 (i.e., conforms to ATS/ERS 2005). |
| Volume Range | 0.1 - 8 Litres (MicroLab). 0 - 8 l as per ATS/ERS (Micro Diary). | Identical to K100928 (0 - 8 l as per ATS/ERS). |
| Flow Range | 0.2 - 15 Litres/Second (MicroLab & Micro Diary). | 0 - 14 l as per ATS/ERS. |
| Sterilization | Turbine can be sterilized or cleaned. | Identical to K100928 & K031102. |
| Environmental Specifications | Operating: 0 to +40 °C, 30% to 90% RH (MicroLab & Micro Diary). | Operating: 10 to +35 °C, 20% to 80% RH. |
Summary of Device Testing (Evidence of Meeting Acceptance Criteria):
The document states that the following practices were followed and monitored for the development of the Micro I Spirometer, forming the basis of its substantial equivalence claim:
- Design and Development QP 0301: Device was developed in accordance with CareFusion's internal design and development quality procedure.
- IEC 62366 (Usability): Modifications were developed according to this usability standard.
- ISO 14971 (Risk Analysis): A Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications.
- Biocompatibility (ISO 10993-1): Tested for patient-contacting materials at Nelson test laboratory in the USA.
- Safety and EMC Testing (IEC 60601-1 and IEC 60601-2): Device underwent electrical safety and electromagnetic compatibility testing.
- Packaging Test: Performed.
- Environmental Testing (Climatic Chamber): Performed to evaluate performance under various environmental conditions.
- Testing according to ATS/ERS standardization of lung function testing: This is the most direct evidence for the spirometry performance characteristics (accuracy, volume/flow ranges, etc.). The device's accuracy and volume/flow ranges are stated to be "Identical to K100928" or "as per ATS/ERS," directly referring to these standards as the acceptance criteria.
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Testing according ATS/ERS standardization of lung function testing," which implies that the device was validated against the performance requirements outlined in these standards. However, the exact number of test subjects or a specific test dataset is not provided.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing was carried out by CareFusion internally and via a third-party lab (Nelson Test Laboratory for biocompatibility, located in the USA).
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies with expert reviewers. The ground truth for spirometer performance is typically established by comparing the device's measurements against established, precisely calibrated reference systems or standards (like those from ATS/ERS).
4. Adjudication Method
Not applicable. Since the 'ground truth' for this type of device is based on technical standards and calibrated measurements rather than expert consensus on diagnostic images or clinical outcomes, an adjudication method like 2+1 or 3+1 is not relevant here.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically performed for AI-powered diagnostic devices where human readers are interpreting data (like medical images) with and without AI assistance to measure improvement in diagnostic performance. The Micro I is a measurement device (spirometer), not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The "Testing according ATS/ERS standardization of lung function testing" would be a standalone performance evaluation of the device's measurement algorithms and hardware against established standards, without human interpretation as part of the primary measurement. The spirometer outputs numerical values (e.g., FEV1, FVC), and its accuracy is assessed against a gold standard for these measurements.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is technical standards and calibrated measurements, specifically those established by the American Thoracic Society (ATS) / European Respiratory Society (ERS) standardization of lung function testing (2005). These standards define the acceptable accuracy, volume range, and flow range for spirometers.
8. Sample Size for the Training Set
Not applicable. The Micro I spirometer is described as a microprocessor-based device converting airflow to an electrical signal, and
calculating values using "onboard software." It does not appear to be an AI/machine learning-based device that would typically have a "training set" in the sense of supervised learning. Its algorithms are likely deterministic and based on physical principles of flow and volume measurement.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention or indication of a training set in the context of machine learning. The device's operation is based on established scientific principles and engineering design, with performance validated against international standards.
§ 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).