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U.S. Department of Health and Human Services

Product Classification

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Device ingestible event marker
Regulation Description Ingestible event marker.
Definition To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device
Physical State The system is composed of an ingestible microsensor, a data recorder in the form of a skin patch, and software
Technical Method The grain-of-sand sized microsensor is designed to communicate the time-stamped confirmation of dosing as a unique identifier to the Proteus ingestion recorder worn on the skin. The ingestion signal is communicated via volume conduction communication also known as intra-body communication. The IEM is attached to an inert pharmaceutical excipient tablet for ease of handling and swallowability.
Target Area Digestive tract.
Regulation Medical Specialty General Hospital
Review Panel Gastroenterology/Urology
Product CodeOZW
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 880.6305
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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