This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:   Avive Automated External Defibrillator (AED) 
PMA Applicant:  Avive Solutions, Inc.
Address:               223 Mississippi Street, Unit 2,
                               San Francisco, CA 94107
Approval Date:   October 31, 2022
Approval Letter:  Approval order

What is it?

The Avive Automated External Defibrillator (AED) is an automatic, portable, battery-operated AED that includes everything needed to treat people experiencing sudden loss of heart function (sudden cardiac arrest). The device is used with a disposable and replaceable Avive Pad Cartridge that securely attaches to the Avive AED. The cartridge has two self-sticking, single use, electrode pads used for treatment. The Avive AED is has an internal battery that can be recharged. It also performs daily, weekly, and monthly self-tests to help make sure it is ready to be used when needed in an emergency.

How does it work?

The Avive AED provides voice prompts and visual indicators to guide both trained and untrained users through a resuscitation sequence, which may include delivering a shock to the heart (defibrillation treatment) and/or CPR (cardiopulmonary resuscitation). When activated, the user is instructed to apply the electrode pads onto the bare chest of someone who is unresponsive and may be in cardiac arrest. After the pads are placed, the device records the electrical signals in the patient’s heart and analyzes the cardiac rhythm. The Avive AED can tell the difference between cardiac rhythms that need an electric shock and those that won’t respond to a shock. It automatically delivers an electrical shock when needed.

When is it used?

The Avive AED is intended to be used in an emergency for people who are showing symptoms of cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally.

After the AED analyzes the patient’s electrocardiogram and interprets the cardiac rhythm, it can automatically deliver an electrical shock to treat life threatening abnormal heart rhythms (ventricular fibrillation) or a rapid, irregular heartbeat in the lower chambers of the heart (ventricular tachycardia) with no detectable pulse (pulseless). After a shock is delivered, the Avive AED prompts the user to start CPR.

The Avive AED is indicated for use in adults and children who are one (1) year of age or older. For someone who is younger than eight (8) years old or less than 55 pounds, the Avive AED should be used in Child Mode. Otherwise, the Avive AED should be used in Adult Mode. However, therapy should not be delayed in order to determine someone’s exact age and/or weight.

What will it accomplish?

The combination of CPR and early defibrillation is highly effective in saving a person’s life when used in the first few minutes following collapse from sudden loss of heart function. For every minute that passes between when a patient collapses from sudden cardiac arrest and when they receive defibrillation, survival rates decrease 7 to 10%. Use of the Avive AED can reduce the time in cardiac arrest and increase the chance of patient survival.

When should it not be used?

The Avive AED should not be used if the patient is responsive or conscious.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• Labeling Part 2
• PMA Database entry