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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 Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS200003 / PSS001
Date Current Plan Accepted 03/25/2021
Study Name Sampling and Culturing Study
Root Document Number K193182 
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 TJF-Q190V duodenoscopes will be sampled and cultured after reprocessing by trained healthcare facility staff using Olympus’ reprocessing instructions.

The study objectives are as follows:

1. To identify the percentage of clinically used duodenoscopes that remain contaminated with viable microorganisms after use of labeled reprocessing instructions.

2. For devices that remain contaminated after use of labeled reprocessing instructions, to determine the factors that contributed to microbial contamination and identify action items necessary to adequately decontaminate the devices.
Study Population Description The study population consists of Olympus TJF-Q190V 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 850 properly collected samples from a minimum of 10 sites. These samples will be collected from a minimum of 85 scopes, with a maximum of 10 samples collected per scope. In addition, no more than 10% of all samples will be collected from brand new TJF-Q190V duodenoscopes, with the term “brand new” being defined as a duodenoscope that has never been used clinically.

Study Milestones:

- First sample collected by April 2021

- 20% of samples collected by July 2021

- 50% of samples collected by October 2021

- 100% of samples collected by January 2022

- Final Report submission by April 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 to identify the root causes of positive samples will be conducted for any positive sample, and risk mitigation strategies will be identified.


Sampling and Culturing Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
three month report 07/17/2020 07/16/2020 On Time
six month report 10/17/2020 10/19/2020 On Time
nine month report 01/17/2021 01/21/2021 On Time
one year report 04/17/2021 04/19/2021 On Time
15 month report 07/16/2021    
18 month report 10/14/2021    
21 month report 01/12/2022    
24 month report 04/12/2022    


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