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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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CARPEDIEM 522


 
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General
Study Status Delayed
522 Number / Requirement Number PS200006 / PSS001
Date Original Plan Accepted 10/01/2020
Date Current Plan Accepted 11/14/2023
Study Name CARPEDIEM 522
Device Name Carpediem
Root Document Number DEN180055 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, single-arm, observational study to capture data on children who undergo CRRT using the Carpediem™ system. This is a new enrollment study.
Study Population All patients who receive CRRT with the Carpediem™ system, as prescribed by the investigator, will be offered participation in the post market surveillance study after obtaining parental consent.
Sample Size The study will enroll at least 30 subjects treated with the Carpediem™ system. A minimum of 10 centers in the United States, that have been trained on the use of the Carpediem™ system, will be invited to participate in the
study.
Study Milestones:
- First patient enrolled by July 2021
- 20% of patients enrolled by October 2021
- 50% of patients enrolled by January 2022
- 100% of patients enrolled by April 2023
- Final report submission by August 2023
Key Study Endpoints The primary endpoints are:
1. Percent of patient survival to CRRT discontinuation
2. Percent of patient survival to intensive care unit (ICU) discharge
The secondary endpoints are:
1. Survival at hospital discharge, and 30 and 90 days
2. Hospital and ICU length of stay
3. Quantification of CARPEDIEM system-related adverse events
4. Renal function recovery at hospital discharge and 30 and 90 days
5. Characterization of survival based on variables including, but not limited to; demographic data, laboratory values, patient acuity prior to CRRT initiation and CRRT treatment parameters
6. Time to CRRT discontinuation
Follow-up Visits and Length of Follow-up Data from each patient treated with CARPEDIEM will be collected throughout their hospitalization and at 30- and 90-days following hospital discharge.
Interim or Final Data Summary
Interim Results Safety Results
Two new non-device related adverse events were reported.

Effectiveness Results
Two device deficiencies were reported.
No protocol deviations were reported.
Actual Number of Patients Enrolled 11
Actual Number of Sites Enrolled 6
Patient Followup Rate During this reporting period: Completed: 4 (36.4%), Not completed: 7 (63.6%), Lost to follow-up: 0 (0%), Exit the study: 5 (100%)
Study Strengths and Weaknesses Weaknesses: Slow study enrollment, small sample size, no comparator group.


CARPEDIEM 522 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/01/2021 04/05/2021 On Time
1 year report 10/01/2021 10/01/2021 On Time
18 month report 04/05/2022 04/05/2022 On Time
2 year report 10/02/2022 09/28/2022 On Time
3 year report 10/02/2023 09/29/2023 On Time
4 year report 10/02/2024    


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