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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Postmarket Surveillance Study


 
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General
Study Status Noncompliant
522 Number / Requirement Number PS200005 / PSS001
Date Current Plan Accepted 07/01/2021
Study Name Postmarket Surveillance Study
Root Document Number K191416 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Desara One single incision sling compared to Desara Blue Sling System implanted via TOR for the treatment of women with stress urinary incontinence (SUI).
Study Population Description The device group is comprised of women with SUI treated with the Desara One sling.

The comparison group is comprised of women with SUI treated with the Desara Blue sling. The study inclusion/exclusion criteria are the same as for the device group
Sample Size At least 300 subjects overall (150 per arm) accounting for 25% attrition at 3 years will provide sufficient power for testing both safety endpoints (adverse event rates and revision/resurgery rate) using a +10% non-inferiority margin with 80% power and a one-sided 5% significance level. Expected AE rate for sling systems is 10%. Expected revision/resurgery rate for sling systems is 3.5%.

A sample size of 142 subjects overall (71 per arm), and accounting for 25% attrition at 3 years will provide sufficient power for testing the primary effectiveness endpoint with 80% power, a one-sided 5% significance level, and a 15% non-inferiority margin. Expected success rate for the sling systems is 85%.
Data Collection All study data will be collected on standardized electronic case report forms (eCRFs) provided by Caldera.
Follow-up Visits and Length of Follow-up 36 months

Hospital discharge, 2 weeks, 6 weeks, 6, 12, 24, and 36 months post procedure


Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/05/2020 12/07/2020 On Time
1 year report 06/05/2021 06/07/2021 On Time
18 month report 12/05/2021    
2 year report 06/05/2022    


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