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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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Reconfirmation Analysis Mode Algorithm PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P160022 / PAS001
Date Original Protocol Accepted 12/27/2017
Date Current Protocol Accepted 05/19/2021
Study Name Reconfirmation Analysis Mode Algorithm PAS
Device Name X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Battery Pack, SurePower II™ Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3™ Battery Pack, SurePower™ Charger, and SurePower™ Single Bay Charger
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective observational study with newly enrolled patients. Enrollment for this study is approximately 70 months. Subjects are enrolled once the Zoll X Series, R series, AED Pro, or Zoll AED 3 is connected to the patient via electrodes and ECG data capture begins. Data collection will contine to through the duration of the resuscitation event while the ECG capture is in place.
Study Population Subjects are enrolled in this study when they are found in cardiac arrest and receive attempted resuscitation by participating EMS agencies and treatment with the ZOLL X-Series defibrillator. Subjects meeting the labeled indications for use will be recruited into the study with the following inclusion and exclusion criteria based on the current labeling for X-Series.
Inclusion Criteria:
Candidates for this study must meet all of the following criteria:
1. Age greater than or equal to 8 years and weight greater than or equal to 55 pounds (25 kg)
2. Out-of-hospital cardiac arrest (OOHCA)
3. Non-traumatic arrest
Exclusion Criteria:
Candidates will be excluded from the study if any of the
following conditions are present:
1. Weight less than 55 pounds (25 kg)
2. Do-not-attempt-resuscitation (DNAR) orders.
Sample Size Approximately 2500 subjects are planned to be enrolled in the study to provide adequate data for all rhythms in the final analysis. Currently, the rate limiting rhythm is anticipated to be Rapid VT as it quickly degrades to VF and is rare to capture in waveform data. Historically, only 2% of all rhythms assessed in previous datasets were categorized as rapid VT. To satisfy the minimum of 50 subjects for rapid VT, 2500 subjects will be enrolled.
Based on Kerber’s sample size and performance goals listed in the Kerber et al. 1997 article referred above, the following minimum sample sizes for five different categories of rhythm will be required for this study.
For Coarse VF,
When the sample size is 200, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.027 from the observed proportion for an expected proportion of 0.900.
For Rapid VT
When the sample size is 50, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.078 from the observed proportion for an expected proportion of 0.750.
For Non-Shockable Rhythm
When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.013 from the observed proportion for an expected proportion of 0.990.
For Other Non-Shockable Rhythms (AF, SB, SVT, PVCs)
When the sample size is 30, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.051 from the observed proportion for an expected proportion of 0.950.
For Asystole
When the sample size is 100, a one-sided 90.0% confidence interval for a single proportion using the large sample normal approximation will extend 0.028 from the observed proportion for an expected proportion of 0.950.
Key Study Endpoints The primary endpoint is the accuracy of the RAM algorithm (i.e., measured as sensitivity for shockable rhythms and specificity for non-shockable rhythms for the algorithm) compared to manual annotation for each rhythm type.
Primary outcome measure:
ECG data files will be manually annotated as shockable or non-shockable by two (2) non-physician experts in ECG cardiac rhythm analysis and one (1) physician expert in ECG analysis. This annotation will be based on the ECG waveform immediately following the end of the CPR compression interval only; that is, the annotation will be done only with the portion of the ECG waveform that is free from CPR artifact. The shock determination decision reached by the cardiac monitor will be compared with the manual annotations of the same ECG data by the three (3) experts.
Follow-up Visits and Length of Follow-up No follow-up visits
Interim or Final Data Summary
Interim Results 1581 segments have been included in the algorithm analysis and the sensitivity and specificity of the algorithm for these segments have been reported to be within the performance goals
Actual Number of Patients Enrolled 284
Actual Number of Sites Enrolled 3
Patient Follow-up Rate N/A
Study Strengths & Weaknesses The sponsor is intending to enroll more patients within the clinical sites


Reconfirmation Analysis Mode Algorithm PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/27/2018 07/18/2018 Overdue/Received
one year report 12/27/2018 01/03/2019 Overdue/Received
18 month report 06/27/2019 06/26/2019 On Time
two year report 12/27/2019 12/12/2019 On Time
three year report 12/26/2020 12/23/2020 On Time
4 year report 12/26/2021 01/05/2022 Overdue/Received
5 year report 12/26/2022    
6 year report 12/26/2023    
7 year report 12/26/2024    
final report 04/28/2025    


Contact Us

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

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