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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.
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| 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).
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| 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
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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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| 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%
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