(129 days)
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope/MasterScope ECG represent partial quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.
It can be used by physicians in the office or hospital.
The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.
The MasterScope is a portable device, which can collect spirometry and ECG data.
With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph).
The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station.
With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use.
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights).
MasterScope provides automated and secure data transmission to a centralized data base.
The measured data is saved into the MasterScope software and can be read out at any time.
A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet.
The MasterScope WSSU is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
The provided text describes the MasterScope WSSU device and its substantial equivalence to predicate devices, focusing on spirometry and ECG functions. The information relevant to acceptance criteria and study proving device performance is primarily found in the "Summary Table of Comparison" (pages 7-8) and "Summary of Device Testing" (page 12).
Here's an analysis of the provided information against the requested points:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance specifications for the pulmonary function measurements, which serve as acceptance criteria.
Pulmonary Function Performance Comparison
| Characteristic | Acceptance Criteria (Predicate/Reference Device) | Reported Device Performance (MasterScope WSSU) |
|---|---|---|
| Accuracy - PEF | 0.1 to 16 L/s: ±10% of reading or +/-0.3 L/s (SpiroSphere K173937) | 0.1 to 16 L/s: +/- 10% of reading or +/- 0.3 L/s |
| Accuracy - FEV1 and FVC | 0.1 to 8 L: ± 3% of reading or +/- 0.050 L (SpiroSphere K173937) | 0.1 to 8 L: +/- 3% of reading or +/- 0.050 L |
| Accuracy - Instantaneous flow | 0.1 - 14 L/s: ± 5% or 0.2 L/s (SpiroSphere K173937) | 0.1 - 14 L/s: ± 5% or 0.2 L/s |
| Resolution - PEF |
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).