(70 days)
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
The GoSpiro® is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.
The provided text describes a 510(k) premarket notification for the GoSpiro® device, which is a diagnostic spirometer. The primary change introduced in this submission (K202837) is the ability to clean, disinfect, and reuse the turbine for multi-patient, multi-use, as opposed to the predicate device (K163249) where the turbine had to be replaced if no filter was used.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for all device functionalities. However, it implicitly uses the predicate device's specifications as the standard for equivalence. The key performance parameters related to spirometry and their stated values are:
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (GoSpiro®) |
|---|---|
| Flow Range: ±14 l/s | Flow Range: ±14 l/s |
| Flow Accuracy: ±5% or 200 mL/s | Flow Accuracy: ±5% or 200 mL/s |
| Flow Resistance: 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) | Flow Resistance: 137 Pascals (Pa) per Liter per second, measured at 14 Liters per second (Lps) |
| Volume Range: 0-8 liters | Volume Range: 0-8 liters |
| Volume Accuracy: ±3% of reading, or 0.05 liters, whichever is greater | Volume Accuracy: ±3% of reading, or 0.05 liters, whichever is greater |
| Compliance with ATS Spirometry guidelines | Complies with ATS Spirometry guidelines |
| Compliance with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Water Ingress Protection: IP22 | Water Ingress Protection: IP22 |
| Biocompatibility: Externally communicating (Indirect), Tissue and Surface Contact, Mucosa, limited exposure | Similar patient contact and identical materials (Biocompatibility evaluated per ISO 10993-1) |
| Cleaning of mouthport (predicate) | Cleaning of mouthport (Same mouthport); Cleaning and disinfection of Turbine (Proposed) |
The primary acceptance criterion that needed separate validation for the proposed device was the effectiveness of turbine cleaning and disinfection. The document states: "The validation testing has been performed demonstrating that the turbine may be cleaned, disinfected and reused." This implies that the acceptance criteria for cleaning and disinfection (e.g., reduction of microbial load, retention of device functionality, no adverse material degradation) were met, though the specific quantitative criteria are not detailed in this excerpt.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "High level disinfection validation", "Post-disinfecting performance", and "Post-disinfecting biocompatibility" as types of performance testing.
- Sample Size: The document does not specify the sample size used for these validation tests (e.g., number of turbines subjected to disinfection, number of cycles tested, or number of biological or performance tests).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the excerpt. The studies mentioned (disinfection, performance, biocompatibility) are laboratory/engineering tests, not clinical studies that typically involve expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The studies described are validation tests (e.g., disinfection efficacy, material properties, device function) rather than clinical evaluations requiring expert adjudication of results.
5. 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
An MRMC study is not applicable as the GoSpiro® is a diagnostic spirometer for measuring lung function, not an AI-assisted diagnostic tool that relies on human readers interpreting images or data with and without AI. It directly measures physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context of the GoSpiro® device. It is a physical medical device that measures spirometry parameters. Its "performance" is determined by the accuracy and precision of its physical measurements, not by an algorithm's standalone diagnostic capability in the absence of human interaction (beyond the user performing the spirometry maneuver). The device and its internal program perform calculations to meet ATS/ERS requirements, and its accuracy targets are detailed above.
7. The Type of Ground Truth Used
For the core spirometry measurements (Flow, Volume, Accuracy, Resistance), the ground truth is implicitly based on established physical and physiological standards and measurement principles (e.g., traceable reference spirometers or calibrated flow/volume sources). For the specific validation related to the new submission:
- Cleaning and Disinfection Validation: The ground truth would likely be established through standard microbiological testing methods (e.g., reduction of specified microorganisms to acceptable levels) and material compatibility assessments according to recognized standards (e.g., AAMI TIR12, ISO 17664, or specific FDA guidance).
- Post-disinfecting performance: The ground truth would be that the device, after disinfection, continues to meet its specified flow/volume accuracy and resistance criteria.
- Post-disinfecting biocompatibility: The ground truth would be that the materials, after disinfection, remain biocompatible as per ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable as the GoSpiro® is a physical measurement device and its underlying technology (bidirectional turbine) and internal program for calculations are not described as based on machine learning or AI models requiring a "training set" in the conventional sense. The "internal program" would be developed based on physics and engineering principles, not statistical learning from data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
§ 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).