Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker

Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker


Publication/Creation Date
May 14 2012
Creators/Contributors
Food And Drug Administration (FDA) (creator)
Proteus Digital Health (creator)
Persuasive Intent
Information
Description
FDA summary of Proteus' Ingestible Event Marker, including regulatory information, background information, device description, safety testing studies, and a summary of the clinical information.

"The Proteus Personal Monitor, also called the “Patch”, is a body-worn sensor that collects physiological and behavioral metrics including heart rate, activity, body angle and time-stamped user-logged events generated when a user marks an event by swallowing an Ingestion Event Marker (IEM) or by manually pressing an event marker button on the Patch. The Patch stores and wirelessly sends the IEM data to a general computing device. The Proteus Personal Monitor Including Ingestion Event Marker system is comprised of three main subsystems; (1) the ingestion event marker (IEM), (2) the data recorder (Patch), and (3) the Proteus software."
HCI Platform
Ingestible
Discursive Type
Inventions
Location on Body
Digestive Tract, Skin
Source
https://www.accessdata.fda.gov/cdrh_docs/reviews/K113070.pdf

Date archived
October 30 2020
Last edited
November 3 2020
How to cite this entry
Food and Drug Administration (FDA), Proteus Digital Health. (May 14 2012). "Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker". Food and Drug Administration (FDA). Fabric of Digital Life. https://fabricofdigitallife.com/Detail/objects/4975