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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS200002 / PSS001 |
| Date Original Plan Accepted |
06/23/2020
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| Date Current Plan Accepted |
10/02/2020
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| Study Name |
Human Factors Study
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| Device Name |
Evis exera iii duodenovideoscope tjf-q190v
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| Root Document Number |
K193182
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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.
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| 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).
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| Key Study Endpoints |
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.
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| Interim or Final Data Summary |
| Final Effectiveness Findings |
Olympus’ supplemental human factors study was conducted with five (5) GI nurses and five (5) GI techs and evaluated user understanding of and adherence to the current reprocessing materials for TJF-Q190V duodenoscopes in the following core reprocessing areas: precleaning, manual cleaning, manual high[1]level disinfection, rinsing, and storage and disposal. GI nurses had successful performance on the sixteen (16) precleaning critical tasks, obtaining 100% success. GI techs are responsible for accessory inspection, leak testing, manual cleaning, manual high-level disinfection, and presoaking. The combined reprocessing performance success for the GI techs was 96%. For accessory inspections, 30 out of 35 tasks were successfully performed (86%). Similarly, success rates for other critical tasks were high: leak testing (93%); manual cleaning (98%); manual high-level disinfection (94%); and presoaking (99%). Finally, participants demonstrated high understanding of critical information in the IFU and user manuals, with knowledge task success rates of 100% for GI nurses and 98% for GI techs. These results, when taken together with the HF testing that was previously conducted for TJF-Q190V reprocessing instructions in the 510(k) submission, demonstrate that the current reprocessing user materials for TJF-Q190V duodenoscopes are sufficient to achieve a high user success rate for user performance and knowledge of reprocessing tasks.
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