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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS150001 / PSS001 |
| Date Original Plan Accepted |
04/23/2015
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| Date Current Plan Accepted |
02/23/2021
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| Study Name |
Post-market Surveillance Study (PSS)
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| Device Name |
Hummingbird tympanostomy tube system
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| Root Document Number |
K142282
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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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 |
Infant: 29 days-2 yrs,
Child: 2-12 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
Children 6 months through 5 years of age, who are candidates for placement of a ventilation tube.
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| 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.
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| Key Study Endpoints |
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.
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| 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.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Prospective: 10
Retrospective: 99
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| Actual Number of Sites Enrolled |
Prospective: 1
Retrospective: 3
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| Patient Followup Rate |
Patients were followed through discharge
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| 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.
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| 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.
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| 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.
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| Recommendations for Labeling Changes |
Sponsor should submit updated labeling for the device, revised to incorporate the results of this post-market surveillance study.
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