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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 Study Pending
522 Number / Requirement Number PS200007 / PSS001
Date Current Plan Accepted  
Study Name Human Factors Study
Root Document Number K200741 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a post-market human factors validation study of the Tablo Hemodialysis System in participants with end stage renal disease in the home setting. The study is designed to include both a simulated-use human factors study and a prospective, multi-center actual-use human factors study. This is a new enrollment study. To supplement the human factors study, the post-market study will also include an adverse events and complaints analysis for all home users of the device (including for participants in the actual-use study).
Study Population Description The simulated-use study population will be hemodialysis patients and their care partners who are representative home-users.

The actual-use study will enroll participants who plan to start home hemodialysis with the Tablo System. Participants must meet all eligibility criteria and provide written informed consent prior to conducting any study specific procedures not considered standard of care.
Sample Size The simulated-use study will have a sample size of at least 15 participants (15 each of patient and their care partner).

The actual-use study will have a minimum of 15 participants (patients and their care partners).
Data Collection The study endpoints for the actual-use study are:

- Evaluation of use-related performance on critical tasks (including successes, use errors, close calls,

difficulties, and observational use experience).

- Evaluation and analysis of root-cause for any use-related errors, close calls, and difficulties.

- Evaluation of participant comprehension using the Warnings and Cautions Knowledge Tests.

- Descriptive summary of participant demographics (e.g., age, sex, vascular access) compared to

real-world intended users.
Follow-up Visits and Length of Follow-up The length of follow-up for the actual-use study is 2 months.


Human Factors Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/05/2021 09/09/2021 Overdue/Received
1 year report 03/05/2022    
18 month report 09/05/2022    
2 year report 03/05/2023    


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