In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent B (as adults) : 18-21 yrs,
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.
Accounting for a 3% patient dropout, the resulting sample size will be 866.
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.
Followup Visits and Length of Followup
Duration of each subject's participation is approximately 2 days (one day participation and one day
OSB Lead-Open Label PAS of SEDASYS Syst User Resp