| 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 |
Cardiovascular |
|---|
| Product Code | OZW |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| 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 |
