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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Fusion, AEs, Surg Procedures


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General
522 Number / Requirement Number PS090011 / PSS001
Current Plan Approved 04/12/2012
Study Name Fusion, AEs, Surg Procedures
Root Document Number K072969 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description "The design is a prospective multicenter, single-armcohort study with a literature control.

A formal statement of the primary study null and alternative hypotheses is:



Ho: pi-DSS-pi-c<-delta

Ha:pi-DSS-pi-c> -delta



where pi-DSS is the two-year cumulative fusion rate among patients implanted with DSS-TM;TT-c is the fixed (historical control) target; and delta is the selected non-inferiority delta. A non-inferiority margin delta =-0.10 is conventional in similar contexts and was chosen as the value for this study. The literature search resulted in a 75.4% fusion rate for control pedicle screw spinal systems using autograft."

Study Population Description Skelletally mature patients who received DSS ¿ System at T4 to S1 vertabrae as an adjunct to fusion for the cleared device indications.

Sample Size 150 patients, 6 sites
Data Collection Fusion, adverse events, surgical procedures

Follow-up Visits and Length of Follow-up Follow-up visits at 6 wks., 6 mos., 12 mos., and 24 mos. Length of follow-up --- 2 years
Final Study Results
Interim Safety Information 2 sites enrolled and 1 patient enrolled


Fusion, AEs, Surg Procedures Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/28/2011 02/03/2012 Overdue/Received
1 year report 04/28/2012 06/21/2012 Overdue/Received
18 month report 10/27/2012 10/22/2012 On Time
2 yr report 04/27/2013 04/29/2013 Overdue/Received
30 month report 10/27/2013 10/31/2013 Overdue/Received
3 yr report 04/27/2014 04/30/2014 Overdue/Received
4 yr report 04/28/2015 04/30/2015 Overdue/Received
5 yr report 04/28/2016    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance 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). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies 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 522 PS 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 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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