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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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OUS Post Market Evaluation Study

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Study Status Completed
Application Number P170018 / PAS001
Study Name OUS Post Market Evaluation Study
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objectives of the LIFEPAK CR2 defibrillator PAS are:

1. Characterize the performance of the cprINSIGHT algorithm

2. Identify any unanticipated use issues or performance concerns directly attributable to the cprINSIGHT algorithm

3. Evaluate general device usability data collected from LIFEPAK CR2 defibrillator users
Study Population Description The study population is prehospital patients in Amsterdam, The Netherlands, who are presumed to be possible victims of cardiac arrest and who are connected to a LIFEPAK CR2 either at Schiphol International Airport, by Amsterdam Police, or by Amsterdam Fire.
Sample Size The minimum sample size is based on collecting at least 100 cases with coarse VF. It is estimated that about 20% of the cases will have at least one analysis of coarse VF, so the minimum sample size will be 500 patients. It is estimated that in approximately half of the cases with coarse VF, Analysis 1 by the SAS algorithm will reach a Shock Advised decision and there will be no VF after Shock 1, meaning that the cprINSIGHT algorithm will not see VF during the case. In the other approximately half of the cases, cprINSIGHT will analyze VF unless the patient is disconnected from the LIFEPAK CR2 defibrillator before an analysis of VF is completed. Therefore, it is expected that a minimum of 50 cases will have at least one analysis of VF by the cprINSIGHT algorithm.

The plan is to collect cases through the end of 2019 to comfortably exceed the above minimum sample sizes.

The plan is to collect device use survey forms for cases through the end of 2018.

Data Collection Study endpoints are accuracy of the LIFEPAK CR2 shock advisory decisions (made by the SAS algorithm or the cprINSIGHT algorithm), accuracy of just the SAS decisions, and accuracy of just the cprINSIGHT decisions, per the following table:

Rhythm Accuracy 90% Lower Confidence Limit


Coarse VF Sensitivity

Rapid pulseless VT Sensitivity


NSR Specificity

Other QRS rhythm Specificity

Asystole Specificity


Fine VF % shocked

Other VT % shocked

For the device use survey forms, the endpoint is a tabulation of survey answers.

Follow-up Visits and Length of Follow-up no follow-up
Interim or Final Data Summary
Actual Number of Patients Enrolled 790 cases ((33 airport cases, 555 police cases, 201 fire cases, and 1 case using a privately owned device)
Actual Number of Sites Enrolled 3
Patient Follow-up Rate no follow-up, as the device recording and device use survey forms contain the data needed for the study.
Final Safety Findings Overall sensitivity for shockable rhythms was 315/324 = 97.2% [90% LCL 95.6%]. Overall specificity was 1833/1856 = 98.8% [LCL 98.4%].

• The overall proportion of cprINSIGHT analyses that reached a decision with no Pause for SAS was 960/1360 = 70.7%. When the rhythm was coarse VF, 93.1% of cprINSIGHT analyses reached a decision with no Pause for SAS.

• No issues or performance concerns attributable to the cprINSIGHT algorithm were reported.
Final Effect Findings Overall, the usuability gathered through LIFEPAK CR2 Use survey rate was 74%.

• In cases for which the voice prompts were reported to be annoying, distracting, or too verbose, there was no substantial adverse effect on the rescuers’ performance of the clinically important resuscitation tasks.

• The reported difficulty hearing the voice prompts or the metronome did not appear to adversely affect the rescuers’ performance of the clinically important resuscitation tasks, which are delivering CPR and delivering defibrillation shocks when needed.
Study Strengths & Weaknesses Study Strength include large sample size. There are no weaknesses.
Recommendations for Labeling Changes none

OUS Post Market Evaluation Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/21/2019 05/29/2019 On Time
one year report 12/21/2019 11/06/2019 On Time
final report 03/30/2020 02/12/2020 On Time

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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