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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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General
Study Status Progress Adequate
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 This is a postmarket surveillance study intended to measure the accuracy of the shock advisory decisions, SAS decisions, and the cprINSIGHT decisions.
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

Shockable

Coarse VF Sensitivity

Rapid pulseless VT Sensitivity

Nonshockable

NSR Specificity

Other QRS rhythm Specificity

Asystole Specificity

Intermediate

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


OUS Post Market Evaluation Study Schedule

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


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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