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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P970018 S033/ PAS001 |
| Date Original Protocol Accepted |
12/02/2016
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| Date Current Protocol Accepted |
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| Study Name |
BD SurePath Collection Vial-Post-Approval Study
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| Device Name |
BD SUREPATH COLLECTION VIAL
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective is to evaluate the performance of the BD SurePath Collection Vial in detection of LSIL+ results in a clinical use setting. The PAS consists of two study arms to compare the performance of the BD SurePath Liquid-based Pap Test when using 1) the modified BD SurePath Collection Vial (modified vial), and 2) historical data with the previously approved SurePath vial (previous vial). In both study arms, collected cells will be enriched using the BD PrepMate, slides will be prepared using the BD PrepStain and then slides will be evaluated using the FocalPoint GS Imaging System (FPGS). The study population is the entire routine screening population; approximately 15,000 results will be collected per arm. Historical and prospective calculated Bethesda result rates will be stratified into following categories: a) NILM, b) ASCUS, c) ASC-H, d) LSIL and e) HSIL+; and reported for the entire cohort, as well as by laboratory (site). False negative fraction will be calculated by site utilizing each site's quality control (QC) results from NILMs and overall. False negatives are defined as QC results of ASCUS+, LSIL+ and HSIL+, with overall and by site, including 95% confidence interval. The similarity and difference in Bethesda category (abnormality) rates will be calculated (within the context of the unmatched Historical and Prospective populations). If the PAS results indicate clinically and statistically significant inferior performance attributable to use of the Modified Vial, then a limitation will be included in the device labeling and a field action will be conducted to inform users that all potentially impacted slides should undergo re-evaluation using full manual slide review.
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| Study Population |
The study population is the entire routine screening population of the selected sites.
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| Sample Size |
There will be at least two (2) clinical laboratories participating in this study. Approximately 15,000 data points will be collected per study arm.
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| Key Study Endpoints |
Based on the false negative rate for each cut-off (ASCUS+, LSIL+ and HSIL+), the ratios of 1 minus sensitivity and ratio of specificities for the modified vial vs. previous vial at each cut-off will be calculated.
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| Follow-up Visits and Length of Follow-up |
N/A
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Prospective arm Historical arm Total
Site 1 14,768 15,119 29,887
Site 2 4,930 5,100 10,030
Site 1+2 19,698 20,219 39,917
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| Actual Number of Sites Enrolled |
2
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| Patient Follow-up Rate |
All data were obtained from the two laboratories’ normal cervical cancer screening procedures and patient populations. There was no study related patient follow up.
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| Final Safety Findings |
The study assessed False Negative Fraction (FNF) and Ratio of Specificity from the Quality Control (QC) cohorts in both historical and prospective arms and their 95% Confidence Intervals (CI). All of the CIs for FNF and Ratio of Specificity contain ‘1’ in both ASCUS+ and LSIL+ categories indicating that there is no significant change in rates of either false negative or false positive. Therefore, the study demonstrated that use of the Totalys BD SurePath Collection vial with the legacy BD PrepMate and BD PrepStain instruments, along with imaging-assisted screening using BD FocalPoint GS Imaging System has no impact on the safety of the BD SurePath Liquid-based Pap Test.
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| Final Effect Findings |
The study results indicated that the 95% CI of the cumulative Bethesda percentages of ASCUS+, LSIL+ and HSIL+ from the prospective and historical routine population all contain ‘0’. Furthermore, the study results indicated that the 95% CI of the comparison of cumulative Bethesda percentages of ASCUS+, LSIL+ and HSIL+ from the prospective and historical QC cohorts all contain ‘0’. Therefore, the study demonstrated that the use of the Totalys BD SurePath Collection vial with the legacy BD PrepMate and BD PrepStain instruments, along with imaging-assisted screening using BD FocalPoint GS Imaging System has no impact on the effectiveness of the BD SurePath Liquid-based Pap Test.
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| Study Strengths & Weaknesses |
Study strength: A large number of cases were enrolled: the initial study targets of 15,000 routine prospective, 15,000 routine historical, 1,500 ASC-US+ and 50 HSIL were all exceeded. Furthermore, there was no HSIL+ cases observed in either QC cohorts.
Study weakness: Only two sites were enrolled (originally required three sites
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| Recommendations for Labeling Changes |
No labeling changes are required.
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