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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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Post-market Surveillance Study (PSS)


 
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General
Study Status Completed
522 Number / Requirement Number PS150001 / PSS001
Date Current Plan Accepted 02/23/2021
Study Name Post-market Surveillance Study (PSS)
Root Document Number K142282 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs
Detailed Study Protocol Parameters
Study Design Description The objective of this new enrollment study is continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of a ventilation tube in patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

Study Population Description Children 6 months through 5 years of age, who are candidates for placement of a ventilation tube.

Sample Size This study will include a minimum of 109 treated patients. The sample size was chosen to ensure an adequate precision in the estimation of the conversion rate. Based on an expected conversion rate of 15%, a minimum sample size of 109 subjects will provide an upper, one-sided, Wilson 95% confidence bound that is no more than 5% greater than the estimated conversion rate with a probability of approximately 0.94.

Data Collection 1. The rate of conversion from moderate sedation to general anesthesia, along with surgeon experience, the patient and procedure characteristics associated with the decision to convert (age, sex, weight, surgery duration (tympanostomy time for each ear), patient movement, anatomy, and lack of visualization).

2. The rate of intra-operative and pre-discharge AEs and rates for each specific type of event.

Follow-up Visits and Length of Follow-up Follow-up continues until hospital discharge, or in the case of an adverse event, until resolution of the adverse event.

Interim or Final Data Summary
Actual Number of Patients Enrolled Prospective: 10

Retrospective: 99

Actual Number of Sites Enrolled Prospective: 1

Retrospective: 3

Patient Followup Rate Patients were followed through discharge
Final Safety Findings A total of 4 sites participated in the study. Fully 109 patients and 217 ears were treated in the study. The sponsor reported that there were no anticipated or unanticipated adverse events , intra-procedural or through discharge.
Final Effectiveness Findings After pooling the data over study sites, there were 14 conversions (prospective study: 1, retrospective study: 13) to general anesthesia out of 109 procedures. The overall conversion rate was 12.8% with lower and upper confidence bounds of 7.9% and 20.6% respectively. The confidence bounds were calculated using the Clopper-Pearson (or exact binomial) method. The observed conversion rate in the study was not statistically significantly different from the 15% expected value.
Study Strengths and Weaknesses The absence of observed adverse events in the study is highly encouraging. The conversion to general anesthesia occurred at an appreciable rate, 12.8%. It is vital that clinicians be fully informed of the potential necessity of conversion to general anesthesia.
Recommendations for Labeling Changes Sponsor should submit updated labeling for the device, revised to incorporate the results of this post-market surveillance study.


Post-market Surveillance Study (PSS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 MONTH REPORT 07/29/2016 10/13/2016 Overdue/Received
1 yr report 01/28/2017 02/17/2017 Overdue/Received
18 month report 07/28/2017 09/06/2017 Overdue/Received
2 year report 01/28/2018 03/13/2018 Overdue/Received
30 month report 07/29/2018 07/30/2018 Overdue/Received
3 yr report 01/29/2019 01/28/2019 On Time
4 year report 01/28/2020   Overdue
final report 03/15/2021 03/15/2021 On Time


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