Post-Approval Studies (PAS) Database

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

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 yrs < 12 yrs, Adolescent: 13-18 yrs, Adult: At least 22 yrs
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
Interim or Final Data Summary
Interim Results	N/A
Actual Number of Patients Enrolled	1
Actual Number of Sites Enrolled	N/A
Patient Follow-up Rate	A total of 1,080 ECG rhythm segments analyzed by Avive's Rhythm Recognition Detector have been annotated for 336 unique patients. Thus far, the overall sensitivity for shockable rhythms has been 93% and the overall specificity for non-shockable rhythms has been 98%. There have been no unanticipated adverse events or performance findings thus far in the study.

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	05/01/2024	Overdue/Received
2 year report	10/30/2024	10/30/2024	On Time
3 year report	10/30/2025	11/10/2025	Overdue/Received
4 year report	10/30/2026
5 year report	10/30/2027

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background