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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 (PS) Study


 
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General
Study Status Delayed
522 Number / Requirement Number PS210002 / PSS001
Date Original Plan Accepted 06/17/2021
Date Current Plan Accepted 09/15/2021
Study Name Postmarket Surveillance (PS) Study
Device Name Pentax ed32-i10 duodenoscope
Root Document Number K202365 
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 Objectives This is a bench study in which clinically-used ED32-i10 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 ED32-i10 duodenoscopes in use in the clinical setting remain contaminated with low/moderate and high concern bacteria after having been reprocessedin 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 The study population consists of Pentax model ED32-i10 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 12 properly collected samples from a minimum of 4 duodenoscopes. If the first 12 samples identify one or more samples with a high-concern organism or > 100 colony forming units (CFU) of a low- or moderate-concern organism, a minimum of 37 additional properly collected samples (for a total of 49 properly collected samples) will be collected.

Study Milestones:
• First sample collected by July 1, 2022
• 20% of samples collected by October 1, 2022
• 50% of samples collected by January 1, 2023
• 100% of samples collected by April 1, 2023
• Submission of Final Report to FDA by July 1, 2023
Key Study Endpoints 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.
Interim or Final Data Summary
Interim Results (Data as of June 15, 2023)
# of Sites Enrolled: 4
# of Sites Collecting Samples: 4
Total # of Samples Required: 12
# of Properly Collected Samples: 6
# of Samples Positive for Low/Moderate Concern Organisms <100 CFU: 1 / 6 (17%)
# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 0 / 6 (0%)
# of Samples Positive for High Concern Organisms: 0 / 6 (0%)
Range of Contamination Rates Across Sites: 0.0% - 0.0%


Postmarket Surveillance (PS) Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 09/17/2021 09/21/2021 Overdue/Received
6 month report 12/17/2021 12/17/2021 On Time
9 month report 03/17/2022 03/17/2022 On Time
12 month report 06/17/2022 06/10/2022 On Time
15 month report 09/17/2022 09/16/2022 On Time
18 month report 12/17/2022 12/16/2022 On Time
21 month report 03/17/2023 03/17/2023 On Time
24 month report 06/17/2023 06/16/2023 On Time
27 month report 09/17/2023 09/18/2023 Overdue/Received
30 month report 12/17/2023 12/15/2023 On Time
33 month report 03/18/2024 03/15/2024 On Time
36 month report 06/18/2024 06/17/2024 On Time
39 month report 09/18/2024    


Contact Us


Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources


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