Product Classification

• Device: automated external defibrillators (non-wearable)
• Regulation Description: Automated external defibrillator system.
• Definition: This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: MKJ
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: PMA
• Regulation Number: 870.5310
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 3-129 ANSI AAMI EC53:2013/(R)2020
  ECG trunk cables and patient leadwires
• 3-132 ISO 27185 First edition 2012-02-15
  Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
• 3-169 IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Guidance Document

• Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date: Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible