Proteus Digital Health Feedback Device

K150494 · Proteus Digital Health, Inc. · OZW · Jun 27, 2015 · General Hospital

Device Facts

• Record ID: K150494
• Device Name: Proteus Digital Health Feedback Device
• Applicant: Proteus Digital Health, Inc.
• Product Code: OZW · General Hospital
• Decision Date: Jun 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6305
• Device Class: Class 2

Indications for Use

The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.

Device Story

System comprises wearable sensor, ingestible sensor, and software application. Wearable sensor collects heart rate (biopotential), activity/body angle (accelerometer), skin temperature (thermistor), and patient-logged events. Ingestible sensor, embedded in inactive tablet, activates in stomach via bio-galvanic power; communicates unique identifier to wearable sensor via volume conduction. Wearable sensor transmits data to software application for processing, analysis, and display. Used in clinical/research settings for unattended data collection; aids healthcare providers in assessing medication adherence and circadian patterns. Benefits include objective tracking of medication intake and physiological trends.

Clinical Evidence

No clinical data were required; substantial equivalence supported by bench testing and design verification.

Technological Characteristics

Wearable sensor: Ovoid/rectangular form factor, LiMn coin cell battery, 4-16MB memory. Sensors: Biopotential amplifiers (heart rate, impedance), 3-axis accelerometer (activity, body angle), thermistor (skin temperature). Ingestible sensor: Bio-galvanically powered circuit using volume conduction. Software: Proprietary algorithms for R-wave detection and physiological metric quantification. Standards: ANSI/AAMI EC 13 for heart rate.

Indications for Use

Indicated for patients requiring ambulatory monitoring of physiological and behavioral metrics (heart rate, activity, body position) and medication adherence tracking via ingestible sensor technology.

Regulatory Classification

Identification

An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.

Special Controls

In combination with the general controls of the FD&C Act, the Proteus Personal Monitor including Ingestion Event Marker is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.

Predicate Devices

• Proteus® Patch Including Ingestible Sensor (K133263)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is black and white, and the background is white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2015

Proteus Digital Health, Inc. Jafar Shenasa Head, Regulatory Affairs 2600 Bridge Parkway, Suite 101 Redwood City, California 94065

Re: K150494

Trade/Device Name: Proteus Digital Health Feedback Device Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW, DXH Dated: May 22, 2015 Received: May 28, 2015

Dear Jafar Shenasa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

{1}------------------------------------------------

Page 2 - Jafar Shenasa

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use Statement

# 510(k) Number (if known)

Device Name Proteus® Digital Health Feedback Device

The Proteus® Digital Health Feedback Device consists of a Indications for Use miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patientlogged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.

| Prescription Use X<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|--------------------------------------------|----|----------------------|
|--------------------------------------------|----|----------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Proteus Digital Health, Inc.

5-1

{3}------------------------------------------------

### 510(k) Summary

Submitted by: Address:

Telephone: Facsimile:

Contact Name:

Proteus Digital Health Inc. 2600 Bridge Parkway, Suite 101 Redwood City, CA, 94065 [phone] [phone]

Arezou Azar, PhD aazar(a)proteus.com

Date Submitted:

May22, 2015

Name of Device

Trade name: Common name: Classification name: Product Code: Subsequent Codes:

Proteus® Digital Health Feedback Device Ingestible Event Marker Ingestible Event Marker (21 CFR 880.6305) OZW DXH

#### Predicate Device

. Proteus® Patch Including Ingestible Sensor (K133263)

### General Device Description

The Proteus Digital Health Feedback Device consists of a wearable sensor, an ingestible sensor, and a software application.

The Proteus wearable sensor is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), skin temperature, and time-stamped user-logged events signaled by the co-incidence with, or coingestion with, the Proteus ingestible sensor. The display application of the Proteus Digital Health Feedback Device may be used to analyze circadian rhythms and patterns.

The ingestible sensor is embedded inside an inactive tablet. (the Proteus Pill or sensorenabled pill) for ease of handling and swallowing. After the ingestible sensor reaches the stomach, it activates and communicates its presence with a unique identifier to the wearable sensor. When the ingestible sensor is co-ingested with medication, the Proteus device is intended to log, track, and trend medicine intake times as an aid to measure medication adherence.

Proteus Digital Health, Inc.

{4}------------------------------------------------

The software application receives the data from the wearable sensor for further processing and analysis of the physiological and behavioral metrics. The processed data is then sent to the user interface (UI) for display as well as to Proteus databases for storage and sharing.

#### Intended Use

The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.

| Parameter | Values | |
|----------------------------|---------------------------------------|---------------------------------------|
| | The Wearable Sensor | |
| | One Piece | Two Piece |
| Shape | Ovoid | Rectangular |
| Size | 102mm x 60mm x<br>9.8mm | 98mm x 42mm x<br>11mm |
| Weight | 11 grams | 16 grams |
| Battery Type | Lithium Manganese<br>(LiMn) Coin Cell | Lithium Manganese<br>(LiMn) Coin Cell |
| Moisture<br>Susceptibility | Water-Resistant | Water-Resistant |
| Memory | 4 MB | 16 MB |
| Storage<br>Temperature | Room Temperature | Room Temperature |
| Relative Humidity | Ambient | Ambient |
| | The Pill | |
| Shape | Round | |
| Size | 6.5mm x 2.0mm | |
| Weight | 80mg | |

## Physical Characteristics

{5}------------------------------------------------

## Technological Characteristics

The technological characteristics of the current device are identical to the predicate device.

| Parameter | Sensor Technology | Method |
|-------------------------|------------------------------------------------|-----------------------------------------------------|
| Heart rate | Biopotential low-frequency<br>amplifier | Digitized R wave |
| Activity | Accelerometer | Digitized accelerometer output |
| Body Angle | Accelerometer | Double integration of<br>accelerometer output |
| Skin Temperature | Thermistor | Digitized voltage from small<br>auxiliary current |
| Manual Event Logging | Patient activated button | Digital pulse |
| Inter-Electrode | Biopotential high-frequency<br>amplifier | Digitized impedance from small<br>auxiliary current |
| Impedance | | |
| Ingestible Event Marker | Bio-galvanically powered<br>ingestible circuit | Volume conduction<br>communication |

## Summary of Non-Clinical Performance Data

The three-axis accelerometer provided motion and angle relative to gravity (body position) data and was validated against a known acceleration applied against each of its three axes.

The biopotential low-frequency amplifier was used to quantify heart rate by measuring Rwave frequency based upon a proprietary algorithm, tested using selected guidelines set forth in the ANSI/AAMI EC 13 standard.

The thermistor provided local skin environment temperature. A small current was applied across the thermistor, and the difference in voltage was quantifed and compared to a reference resistor.

The ingestible sensor was tested for activation time and lifetime after activation.

## Summary of Clinical Performance Data

No additional clinical data were required to confirm substantial equivalence to predicate devices.

### Conclusion

Based on technological characteristics, risk evaluation, and design verification of the Proteus Digital Health Feedback Device, Proteus Digital Health believes that the product is safe and effective, and is substantially equivalent to its predicate device.

Proteus Digital Health, Inc.