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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Open Label PAS of SEDASYS Syst User Resp


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General
Application Number P080009 / PAS001
Current Plan Approved 03/23/2015
Study Name OSB Lead-Open Label PAS of SEDASYS Syst User Resp
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is designed to evaluate the SEDASYS® System can be used safely in routine clinical practice by measuring the trained users responses to System alarms. The intent of this study, as well as the companion study, is to remove the Restriction of Use limiting initial use of the SEDASYS System to settings where an anesthesia provider is immediately available.

Study Population Description Up to 32 users in up to 15 sites.
Sample Size Accounting for a 3% patient dropout, the resulting sample size will be 866.
Data Collection The primary endpoint will be the percentage of documented responses to alarms.

The secondary endpoint will be the sufficiency of response, which is measured by a score for success.

Other Safety Endpoints:

Adverse events (defined by MeDRA) and all hands-on airway rescue interventions by anesthesia providers will be reported. Stopping Rules:

The study may be stopped by the Sponsor in the event of a single confirmed non-response to an alarm (desaturation, apnea, hypotension, bradycardia). Confirmation of a non- response will be determined by the EAC; assessment will include if the Data Acquisition System (DAQ) failed to record a response. The reason for failure to respond will be assessed by EES and continuance of the study will be based on this assessment. The expected rate of DAQ failure is approximately one percent. Confirmed non-responses will be sent to the Agency within 15 days of the EAC notifying the Sponsor.

Follow-up Visits and Length of Follow-up Duration of each subject's participation is approximately 2 days (one day participation and one day follow up).



OSB Lead-Open Label PAS of SEDASYS Syst User Resp Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014 10/30/2014 On Time
two year report 05/03/2015 04/23/2015 On Time
Final Report 06/03/2016 05/03/2016 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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