Link Search Menu Expand Document

Legal & Safety Information (CardioCare@Home Pro)

CE mark

Table of contents
  1. Introduction
    1. Intended Use
    2. Intended Users
    3. Clinical Indications
  2. Safety Information
    1. Warnings
    2. Security
    3. Package and Device Symbols
  3. Regulatory Information
    1. Declaration of Conformity
    2. CardioCare@Home Pro Compliant Regulatory Standards

LAST UPDATED: August 17, 2021

Introduction

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.

Intended Use

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.

Intended Users

User
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).

Clinical Indications

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.

Safety Information

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.

Warnings

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.

Security

For more detailed security and safety information about CardioCare@Home Pro and Byteflies, please review the Privacy Policy and Our Commitment to data security.

Package and Device Symbols

Symbol Description
Manufacturer
Catalog number
Serial number
CE marking of conformity
Warning
User should consult the instructions for use.

Regulatory Information

Declaration of Conformity

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 Compliant Regulatory Standards

C
CardioCare@Home Pro is compliant with this standard.
R
CardioCare@Home Pro references this standard ("in the spirit of").
Standard Implementation Title
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

Copyright © 2020 Byteflies