f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Avive AED Post-Approval Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P210015 / PAS001
Date Original Protocol Accepted 10/31/2022
Date Current Protocol Accepted  
Study Name Avive AED Post-Approval Study
Device Name Avive Automated External Defibrillator (AED) System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective observational study comparing the Avive AED Rhythm Recognition Detector performance to objective performance criterion.
Study Population N/A
Sample Size 200 cases
Key Study Endpoints The primary study endpoint for this PAS is a >90% sensitivity on Course VF rhythms for the Avive AED, with a 90% One-sided Lower Confidence Limit that is >87%.
The following will also be reported:
-Performance on Rapid VT rhythms for the Avive AED
-Performance on Normal Sinus rhythms for the Avive AED
-Performance on Asystole rhythms for the Avive AED
-Performance on other non-shockable rhythms for the Avive AED, including Atrial Fibrillation, Supraventricular Tachycardia, Sinus Bradycardia, Heart Block, Idioventricular rhythms, and Premature Ventricular Contractions
-Performance on Fine VF for the Avive AED
-Performance on Other VT for the Avive AED
In addition to the ECG analysis performance, the PAS will also report the usability performance of the Avive AED represented by the time elapsed from AED activation to pads placed and if shockable, time to first shock delivered. These data will be extracted and reported from the same AED device log. This information provides the most objective metric of the device usability, incorporating the critical tasks that are required to provide patient treatment.
Follow-up Visits and Length of Follow-up No follow-up required


Avive AED Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/01/2023 04/28/2023 On Time
1 year report 10/31/2023 11/01/2023 Overdue/Received
18 month report 04/30/2024    
2 year report 10/30/2024    
3 year report 10/30/2025    
4 year report 10/30/2026    
5 year report 10/30/2027    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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