(262 days)
The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.
The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters.
Spirometry
Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions
Flow/Volume
The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation).
Maximum Voluntary Ventilation MVV
The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation".
The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity.
The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises:
- the hand-held ScoutSensor
- Base station where the sensor is stored.
- Spirette, a single use, disposable mouthpiece and flow tube
The provided text lacks a detailed study description with acceptance criteria and reported device performance. It primarily focuses on the device's substantial equivalence to a predicate device for regulatory approval. However, certain performance specifications and adherence to standards are mentioned, which can be interpreted as acceptance criteria.
Here's an attempt to extract and present the information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the technical specifications provided for the proposed device (Ganshorn SpiroScout) and are implicitly considered acceptable due to its substantial equivalence claim to the predicate device.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (from predicate/general expectation) | Reported Device Performance (Ganshorn SpiroScout) |
|---|---|---|---|
| Flow Parameters | Flow Range | ± 16 l/s (Predicate) | ± 18 l/s |
| Flow Accuracy | ± 2% or 0.020 l/s (Predicate) |
§ 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).