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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 Study Pending
522 Number / Requirement Number PS210002 / PSS001
Date Current Plan Accepted 09/15/2021
Study Name Postmarket Surveillance (PS) Study
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 Design Description 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 Description 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
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.


Postmarket Surveillance (PS) Study Schedule

Report 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    
9 month report 03/17/2022    
12 month report 06/17/2022    
15 month report 09/17/2022    
18 month report 12/17/2022    
21 month report 03/17/2023    
24 month report 06/17/2023    
final report 07/01/2023    


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