Table of contents
LAST UPDATED: August 17, 2021
CardioCare@Home Pro is a CE Class I software as a medical device (SaMD) for visualization of patient data by a healthcare professional. The CardioCare@Home Pro IFU contains all the information required for safe and correct use of CardioCare@Home Pro. This page summarizes relevant safety and regulatory information.
CardioCare@Home Pro is medical software intended to visualize electrocardiogram (ECG) and actigraphy signals, with additional ECG waveform and beat-to-beat annotations, and vital sign measurements (heart rate and respiratory rate) generated by a compatible medical device. It is intended to be used by a healthcare professional to review, interpret the presented data, and generate a report, in order to provide clinical decision support for the treatment of patients with an indication for at-home electrographic monitoring. CardioCare@Home Pro is not a real-time or remote diagnostic device.
- A healthcare professional monitoring a patient with an indication for at-home ECG monitoring.
CardioCare@Home Pro is intended to be used by Users who can access and view data in a medical environment (e.g. hospital).
CardioCare@Home Pro is intended to be used by healthcare professionals for the treatment of patients indicated for at-home ECG monitoring. CardioCare@Home Pro reads and visualizes data from interoperable medical devices, including but not limited to Byteflies Kit. CardioCare@Home Pro visualizes electrocardiogram (ECG) with beat-to-beat annotations and additional ECG waveform features (P-wave, R-peak, T-wave), heart rate (HR), respiratory rate (RR), and actigraphy data. CardioCare@Home Pro is intended to be used by a licensed medical professional and any interpretation or diagnosis must be made in reference to the signal data, based on their judgement and clinical experience. CardioCare@Home Pro does not derive any ECG or actigraphy features and does not provide any diagnostic conclusion about the patient’s condition.
The following is important information for using CardioCare@Home Pro properly and safely. Carefully read this section before operating the software. CardioCare@Home Pro is a SaMD that visualizes ECG and actigraphy signals acquired elsewhere, and has been tested to assess its safety and effectiveness.
Do not use CardioCare@Home Pro before reading these warnings, the IFU for CardioCare@Home Pro, and -if applicable- a manual for any additional Byteflies accessories:
- CardioCare@Home Pro does not provide any diagnostic conclusion about the patient’s condition. Any interpretation or diagnosis must be made in reference to the signal data.
- The data visualized by CardioCare@Home Pro can only provide clinical decision support to a healthcare professional with relevant training in cardiology, physiology, pulomonology, or a related field.
|CE marking of conformity|
|User should consult the instructions for use.|
CardioCare@Home Pro is in conformity with the essential requirements and provisions of the EU Medical Device Regulation (MDR) 2017/745 concerning medical devices.
- CardioCare@Home Pro is compliant with this standard.
- CardioCare@Home Pro references this standard ("in the spirit of").
|2017/745 EU MDR (2017)||C||EU Medical Device Regulation|
|EN ISO 13485:2016||C||Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes|
|FDA 21 CFR, part 820||C||Quality system regulation for medical device, federal register|
|EN ISO 14971:2019||C||Application of risk management to medical devices|
|IEC 62366-1:2015||C||Medical devices - Part 1: Application of usability engineering to medical devices|
|IEC 62304:2006/ Amd 1:2015||C||Medical device software - Software life cycle processes Amendment 1|
|IEC 82304-1:2016||C||Health software — Part 1: General requirements for product safety 1|
|EN ISO 15223-1: 2016||C||Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements|
|EN ISO 14155:2011||C||Clinical investigation of medical devices for human subjects – Good clinical practice|
|MEDDEV 2.7/1 Rev. 4 (2016)||C||Clinical Evaluation: Guide for manufacturers and notified bodies|
|MEDDEV 2.12/1 rev 8 (2013)||C||Medical Devices Vigilance System|
|MEDDEV 2.12/2 rev 2 (2012)||C||Clinical Evaluation - Post Market Clinical Follow-up|
|MEDDEV 2.7/4 rev 12 (2010)||C||Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies|
|MEDDEV 2.7/3 rev 5 (2015)||C||Clinical investigations: serious adverse event reporting|
|HIPAA (1996)||R||Health Insurance Probability and Accountability Act|
|GDPR 2016/679 (2016)||C||General Data Protection Regulation|
|ISO/IEC 27001:2013||R||Information technology - security techniques - information security management systems - requirements|
|ISO 27799:2016||R||Health informatics — Information security management in health using ISO/IEC 27002|
|FDA Guidance (2002)||R||General Principles of Software Validation; Final Guidance for Industry and FDA Staff|
|FDA Guidance (2016)||R||Applying Human Factors and Usability Engineering to Medical Devices|
|FDA Guidance (2005)||R||Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices|
|FDA Guidance (2017)||R||Deciding When to Submit a 510(k) for a Change to an Existing Device|
|FDA Guidance (2016)||R||Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”|
|FDA Guidance (2019)||R||Safety and Performance Based Pathway|
|FDA Guidance (2013)||R||Radio Frequency Wireless Technology in Medical Devices|
|FDA Guidance (2018)||R||Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT)|
|FDA Guidance (2016)||R||Postmarket Management of Cybersecurity in Medical Devices|
|FDA Guidance (2016)||R||Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)|
|FDA Guidance (2017)||R||Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling|
|IMDRF: SaMD||C||Software as a Medical Device (SaMD): Application of Quality Management System|