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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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Human Factors Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS200002 / PSS001
Date Current Plan Accepted 10/02/2020
Study Name Human Factors Study
Root Document Number K193182 
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population
Detailed Study Protocol Parameters
Study Design Description The purpose of this HF validation test is to validate that the EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V's Reprocessing Manual (RM) is safe and effective for the intended users and uses, in the intended use environments. The HF validation test will also serve to identify any residual use errors that would or could result in serious harm, and to assess the effectiveness of risk management measures.



The HF validation test is designed to expose use errors (ie. mistakes) that could occur when the RM is placed into actual use. The HF validation test is also designed to collect participants' subjective feedback regarding their interactions with the RM.
Study Population Description The study population consists of Olympus TJF-Q190V model duodenoscopes.



In this simulation study, trained healthcare facility staff (including GI nurses and GI techs) will reprocess the scopes in accordance with the manufacturer’s duodenoscope reprocessing manual.
Sample Size At least 5 participants representative of GI/Endoscopy Nurses and at least 5 participants representative of GI/Endoscopy Technicians will be tested (total of 10 test participants, at minimum).
Data Collection This is a simulation human factors study that does not have the traditional safety assessments. The objective of this study is to show that individuals experienced in pre-cleaning and reprocessing of duodenoscopes can successfully read, understand and perform specific tasks as described in the RM. A detailed assessment of the results on user performance data, subjective data, and knowledge data will be performed and, if necessary, mitigations will be employed in situations where failures to successfully follow instructions, as written in the RMs, have been identified.



Human Factors Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 09/21/2020 09/22/2020 On Time
final report 04/17/2022 01/04/2021 On Time


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