QFQ · Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Gastroenterology, Urology · 21 CFR 876.5982 · Class 2

Overview

Identification

This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

Classification Rationale

Class II (special controls). The special controls for this device are:

Special Controls

In combination with the general controls of the FD&C Act, the ingested, transient, space occupying device for weight management and/or weight loss is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: (i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract; (ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and (iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following: (i) Weight change; (ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and (iii) Interaction with representative medications. (4) Physician and patient device labeling must state: (i) The clinical benefit of the device as assessed by using percent total body weight loss; (ii) Treatment must be offered in combination with diet and exercise; (iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and (iv) The shelf life of the device.

Recent Cleared Devices (3 of 3)

Top Applicants

• Gelesis, Inc. — 2 clearances
• Epitomee Medical , Ltd. — 1 clearance