1. Device Identification
Device name: VoiceMed Check for COPD v1.0
Device type: Software medical device (SaMD)
Classification: Class IIa (EU MDR Rule 11)
2. Intended Purpose
VoiceMed Check for COPD v1.0 is intended to analyze user-provided data to identify signs associated with chronic obstructive pulmonary disease (COPD) and to provide adult individuals with information related to COPD. The software is intended to support the identification of individuals who may benefit from further medical evaluation. The software does not provide a diagnosis, does not confirm the presence or absence of disease, and is not intended to replace clinical assessment by a healthcare professional.
3. Intended Use
The software is intended for unsupervised use in non-acute settings by adult individuals. It may be used through digital platforms and is intended for occasional or periodic use. The software provides information indicating whether signs associated with COPD are detected and recommends discussing the result with a healthcare professional.
4. Intended Users
Adult individuals (self-use)
Healthcare professionals (interpretation and follow-up)
5. Target Population
Adult individuals
6. Device Description
VoiceMed Check for COPD v1.0 is a software-based medical device that analyzes user-provided data, including audio recordings and symptom inputs, to identify patterns associated with COPD.
The software does not include any dedicated hardware and uses general-purpose devices such as smartphones, tablets, and computers equipped with a microphone.
The software includes an automated quality check to ensure that recorded audio data are suitable for analysis. If the quality criteria are not met, no result is provided.
7. Instructions for Use
Step 1 – Access
Download the application and enter the access code provided
Step 2 – Provide Information
Answer the symptom-related questions and demographic questions presented in the application
Step 3 – Record Audio
Follow the instructions to record breathing sounds and vocal sounds
Ensure you are in a quiet environment
Step 4 – View Result
After successful recording and quality validation, the software will provide a result
8. Interpretation of Results
Signs associated with COPD were detected
This result suggests that there may be signs associated with COPD
This is not a diagnosis and does not confirm that you have COPD
You should discuss this result with a healthcare professional, who can determine whether further evaluation is appropriate
No signs associated with COPD were detected
This result indicates that no signs commonly associated with COPD were identified
This does not rule out COPD and does not replace medical assessment
If you have symptoms or concerns, consult a healthcare professional
9. Limitations of the Device
The software does not diagnose COPD
The software may produce false positive or false negative results
Results depend on the quality of input data
The software is not intended for emergency or acute situations
The software does not replace clinical evaluation or diagnostic tests such as spirometry
10. Warnings and Precautions
Do not use this software as a substitute for professional medical advice
Do not ignore symptoms based on the result
Seek medical attention if you experience severe or worsening symptoms
Use the software only as instructed
11. Performance Information
The software has been evaluated using clinical data
Sensitivity: 82.9%
Specificity: 59.3%
Performance may vary depending on the population and conditions of use
12. Data Protection and Privacy
User data are processed in accordance with applicable data protection regulations
Pseudonymized data may be used to improve the performance of the software if the user provides consent
13. Operating Environment
The software is intended to run on general-purpose devices with a microphone such as smartphones, tablets, and computers with a compatible operating system
14. Contraindications
None known
15. Maintenance and Updates
The software may be updated periodically to improve performance and safety
Users should install updates when available