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AECD Arrhythmia Detection Software

FDA 510(k)

Class III (US FDA 510(k))

510(k) K982710

by Cardiac Science Corporation

Identifiers

510(k) Number
K982710 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The AECD Arrhythmia Detection Software is a computer-based algorithm designed for automated analysis of electrocardiographic (ECG) waveforms. It identifies ventricular tachyarrhythmias in patients at risk of sudden cardiac arrest, enabling rapid assessment of non-shockable rhythms for treatment decisions.

This software is intended for use within hospital settings, integrated with compatible defibrillator systems like the Powerheart ABCD. Supplied as a digital program, it requires no sterilization or single-use considerations. Authorized under FDA 510(k) clearance (K982710) as substantially equivalent with tracking, it adheres to regulatory standards for cardiovascular devices under classification 3 (D03). No MRI safety or reusable components are specified.

Frequently asked questions

What types of hospitals or clinical settings is this software designed for use in?

The AECD Arrhythmia Detection Software is specifically designed for hospital settings where rapid assessment of ECG waveforms is critical. It is intended to be integrated with compatible defibrillator systems like the Powerheart ABCD, making it suitable for emergency rooms, cardiac care units, and other areas where patients at risk of sudden cardiac arrest may be monitored.

How is the AECD Arrhythmia Detection Software supplied, and are there any sterilization or single-use requirements?

The software is supplied as a digital program, meaning it is not a physical device requiring sterilization or single-use considerations. Since it operates on a computer system, it is designed for repeated use within authorized hospital settings, provided the underlying hardware meets the manufacturer’s specifications.

What regulatory pathway was followed for FDA clearance of this software, and what does that mean for its use?

The AECD Arrhythmia Detection Software received FDA clearance through a 510(k) submission (K982710) under the Special clearance type, with a classification of Class 3 (D03) for cardiovascular devices. This means it was deemed substantially equivalent to a predicate device and is subject to tracking by the FDA, ensuring compliance with regulatory standards for cardiovascular diagnostics in hospital environments.

Is this software compatible with any specific defibrillator systems, and how does it integrate with them?

Yes, the AECD Arrhythmia Detection Software is designed to integrate with compatible defibrillator systems, specifically mentioned as the Powerheart ABCD. It analyzes ECG waveforms to identify ventricular tachyarrhythmias, enabling automated assessment of non-shockable rhythms for clinical decision-making in emergency cardiac care scenarios.

Does this software require any special handling or storage conditions beyond standard IT infrastructure?

Since the AECD Arrhythmia Detection Software is a digital program, it relies on the underlying hardware and IT infrastructure of the hospital’s defibrillator system. No additional storage conditions are specified beyond ensuring the system meets the manufacturer’s technical requirements for reliable operation, such as proper software updates and hardware maintenance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K982710 FDA 510 (k) - AECD ARRHYTHMIA DETECTION SOFTWARE, AECD ARRHYTHMIA DETECTION SOFTWARE (K982710) — FDA 510 (k) - Innolitics, fda.innolitics.com, K982710 FDA 510 (k) - AECD ARRHYTHMIA DETECTION SOFTWARE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K982710 24 fields · synced Sep 18, 2026