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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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Sampling and Culturing


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS190002 / PSS001
Date Current Plan Accepted 05/19/2021
Study Name Sampling and Culturing
Root Document Number K181745 
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population
Detailed Study Protocol Parameters
Study Design Description This is a bench study in which clinically-used model ED-580XT duodenoscopes will be sampled and cultured after reprocessing by trained healthcare facility staff using Fujifilm’s reprocessing instructions.



The study objectives are as follows:

1. Determine the percentage of clinically used duodenoscopes that remain contaminated with viable microorganisms after being reprocessed according to the Fujifilm’s reprocessing instructions.

2. Identify the factors contributing to microbial contamination and the steps necessary to adequately decontaminate the device that remain contaminated after being reprocessed according to the Fujifilm’s reprocessing instructions.

Study Population Description The study population consists of Fujifilm model ED-580XT duodenoscopes that have been used in ERCP procedures and reprocessed by trained healthcare facility staff in accordance with the duodenoscope reprocessing manual.



All duodenoscopes will be subjected to sampling following completion of the cleaning and manual disinfection, or disinfection using AERs listed on the FDA webpage (https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-about-automated-endoscope-reprocessors-aers-and-fdas-evaluation).

Sample Size The study will include a minimum of 36 ED-580XT duodenoscopes at a minimum of 10 sites. The study will continue until 727 properly collected samples are obtained. A maximum of 30 samples will be collected from each scope. No more than 10% of total samples (72 of 727 samples) will come from brand new duodenoscopes. In addition, at least 29 of the 36 scopes used in the study cannot be brand new duodenoscopes.



Study Milestones:

- First sample collected by November 2020

- 20% of samples collected by February 2021

- 50% of samples collected by July 2021

- 100% of samples collected by December 2021

- Final Report submission by March 2022
Data Collection The primary endpoint is successful completion of duodenoscope sampling and culturing to determine real-world contamination rates, where samples are collected from clinically used duodenoscopes from healthcare facilities. Although the expectation is that none of the duodenoscope samples should be positive for high concern organisms or have >100 CFU of low/moderate concern organisms, a thorough investigation will be conducted to identify the root causes of such test results for the identification of the steps necessary to adequately decontaminate the device.


Sampling and Culturing Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 02/18/2020 02/18/2020 On Time
3 month report 03/05/2020 03/12/2020 On Time
6 month report 06/05/2020 06/08/2020 On Time
9 month report 09/05/2020 09/08/2020 On Time
1 year report 12/05/2020 12/07/2020 On Time
15 month report 03/05/2021 03/05/2021 On Time
18 month report 06/05/2021 06/07/2021 On Time
interim report 07/28/2021 07/22/2021 On Time
21 month report 09/05/2021 09/07/2021 On Time
24 month report 12/05/2021    
interim report 12/28/2021    
final report 03/28/2022    


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