| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Obalon Balloon System with Navigation and Touch |
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| Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
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| Applicant | ReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92673 |
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| PMA Number | P160001 |
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| Supplement Number | S031 |
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| Date Received | 01/18/2019 |
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| Decision Date | 07/05/2019 |
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| Product Code |
LTI |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Postapproval Study Protocol |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for The Obalon Navigation Touch System (NTS) Post-Approval Study. The study is a prospective, observational, open-label, multi-center study designed to evaluate the risk of esophageal inflation during Obalon balloon administration in eligible patients. This is a stand-alone, new enrollment study with primary data collection, with no retrospective data acquisition from other sources (i.e., retrospective chart review; data abstraction from existing registries or other data sources). Safety of balloon administration is the focus of this short-term study. Therefore, follow-up of participants ends on the day of balloon administration. However, patients who experience any adverse events related to balloon administration will be followed until resolution of the adverse event. Subjects may re-enter the study for additional balloons as indicated.The co-primary endpoints are: esophageal inflation; and NTS Success defined as balloon inflation in the stomach with the use of the NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal.The study will include a minimum of 3,951 evaluable balloon administrations with at least 1,317 balloon administrations for an individual balloon administration number (1st, 2nd or 3rd). An evaluable balloon administration is achieved if the device capsule passes the upper esophageal sphincter. The sample size of 3,951 is based on the higher sample size required (between the co-primary endpoints) for the esophageal inflation endpoint. The study will enroll a minimum of 1,400 subjects at up to 40 U.S. sites. A participating physician must not exceed 792 (20% of the total) evaluable balloon administrations or 264 for individual balloon type (Balloon 1, 2, or 3). The study will enroll a minimum of 1,000 subjects The first co-primary endpoint, esophageal inflation, is met if none of the Obalon Balloon administrations in the study resulted in an esophageal inflation and the 97.5% one-sided upper exact confidence bound for the estimated esophageal inflation rate is less than 0.1% based on 80% power. The second co-primary endpoint, NTS Success, is met if the one-sided 97.5% lower exact confidence bound is greater than 97% based on 80% power.Other study endpoints include the following: individual device or procedure related adverse event rates; Product Performance Observations (PPO) rates; and percentage of balloon administrations with the following Obalon Navigation System Stomach Location Indicators: Capsules significantly offsets (left lateral) from initial vertical track; Capsules track accelerates; Capsule rotates from vertical to horizontal configuration; and Capsule up/down movement with deep respiration (breath). |
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