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| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS190005 / PSS001 |
| Date Original Plan Accepted |
02/13/2020
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| Date Current Plan Accepted |
04/02/2021
|
| Study Name |
Sampling and Culturing Study
|
| Device Name |
Pentax duodenoscope model ed34-il0t2
|
| Root Document Number |
K192245
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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).
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| 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
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| 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.
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