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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 PS190005 / PSS001
Date Current Plan Accepted 04/02/2021
Study Name Sampling and Culturing Study
Root Document Number K192245 
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 ED34-i10T2 duodenoscopes will be sampled and cultured after reprocessing by trained healthcare facility staff using Pentax’s reprocessing instructions.



The study objectives are as follows:

1. Determine the extent to which ED34-i10T2 duodenoscopes in use in the clinical setting remain contaminated with low/moderate and high concern bacteria after having been reprocessed in accordance with the validated Reprocessing Instructions for Use (RIFU).

2. To evaluate, for devices that remain contaminated after use of Pentax Medical’s labeled reprocessing instruction, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device.

Study Population Description The study population consists of Pentax model ED34-i10T2 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 ED34-i10T2 duodenoscopes, with the term “brand new” being defined as a duodenoscope that has never been used clinically.



Study Milestones:

- First sample collected by February 15, 2021

- 20% of samples collected by May 15, 2021

- 50% of samples collected by August 15, 2021

- 100% of samples (850) collected by November 15, 2021

- Final Report submission by February 15, 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
interim report 01/30/2020 01/30/2020 On Time
3 month report 05/15/2020 05/21/2020 Overdue/Received
6 month report 08/15/2020 08/18/2020 Overdue/Received
9 month report 11/15/2020 11/16/2020 Overdue/Received
1 year report 02/12/2021 02/12/2021 On Time
15 month report 05/15/2021 05/14/2021 On Time
interim report 08/15/2021   Overdue
18 month report 08/15/2021 08/16/2021 On Time
21 month report 11/15/2021    
final report 02/15/2022    


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