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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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Indego Postmarket Surveillance Study


 
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General
Study Status Progress Inadequate
522 Number / Requirement Number PS160003 / PSS001
Date Current Plan Accepted 10/07/2016
Study Name Indego Postmarket Surveillance Study
Root Document Number K152416 
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a post-market registry-based “Enhanced Surveillance” study involving newly enrolled subjects that will collect data on “Indego”-related adverse events (including serious adverse events) such as falls and device malfunctions experienced by institutions, clinicians, personal users and support persons. The sponsor will monitor distribution and trends in incidence of MDR and non-MDR reportable events through ongoing, passive but systematic collection, analysis and interpretation of data. The sponsor will monitor an online data repository (registry) and perform active follow-up according to a pre-specified schedule.

Study Population Description The study population consists of Institutional sites (Group #1), Personal users (Group #2), Support Persons (Group #3) as well as Indego Trainers and Instructors (Group #4). Inclusion and Exclusion criteria were specified for Group #2.

Sample Size The estimated samples sizes are as follows: Institutional sites (n=10)

Personal users (n=15) Support Persons (n=15)

“Indego” Trainers and Instructors (n=10).



Note: In order to justify the sample size of 15 personal users and 15 support persons, the sponsor also specified that if the patient uses this device 3x per week for 12 months after training, a total of 2,340 sessions will be represented in the home and community setting at the end of the study.

Data Collection Main safety endpoints:



Group 1-3: Number of “Indego-related” AEs and SAEs, such as falls and device malfunctions, including detailed information regarding circumstances surrounding such events.

Group 1: Safety of Indego use based on Registry Report

Form.



Group 2: Questions and concerns related to “Indego” based

on Personal use questionnaire.



Group 3: Questions and concerns related to “Indego” based

on Support person questionnaire.



Main Effectiveness Endpoints:



Group 1: Ease of Use; Quality of Indego Training.



Group 2: Quality of “Indego” Training and Comfort level with “Indego” based on Personal use questionnaire.



Group 3: Quality of “Indego” Training and Comfort level with “Indego” based on support person questionnaire; Proficiency / use maintained 12 months after completion of training program.



Group 4: Failure to complete personal use training program and rationale for failure.





Follow-up Visits and Length of Follow-up For Group 1, the duration of follow-up will be 24 months. For Groups 2-4, the duration of follow-up will be 12 months



Indego Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/07/2017 04/03/2017 On Time
1 year report 10/07/2017 10/03/2017 On Time
18 month report 04/07/2018 04/05/2018 On Time
2 year report 10/07/2018 10/03/2018 On Time
3 year report 10/07/2019 10/03/2019 On Time
4 year report 10/06/2020 10/05/2020 On Time
final report 10/06/2021 09/24/2021 On Time


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