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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Generic Nameimplant, intragastric for morbid obesity
5421 avenida encinas
suite f
carlsbad, CA 92008
PMA NumberP160001
Supplement NumberS038
Date Received04/19/2019
Decision Date05/29/2019
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This PMA includes the evaluation of the Obalon Navigation Touch System (NTS) implant procedure and device. P160001 was approved on 9/08/2016 , and P160001/S020 was approved on 12/20/2018 with the following conditions of approval: In addition to the Annual Report requirements, you must provide the following data in post-approval study (PAS) reports for each PAS listed below. Separate PAS Progress Reports must be submitted for each study every six (6) months during the first two (2) years of the study and annually thereafter, unless otherwise specified by FDA. Each report, identified as a "PMA Post-Approval Study Report" in accordance with how the study is identified below and bearing the applicable PMA reference number, should be submitted to the address below.1. PMA Post-Approval Study – Obalon NTS Post-Approval Study: On December 18, 2018 (by interactive e-mail review), you agreed to conduct a post-approval study as follows: The Obalon Navigation Touch System (NTS) Post-Approval 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).