PROTEUS PATCH INCLUDING INGESTIBLE SENSOR

K131524 · Proteus Digital Health, Inc. · OZW · Jun 23, 2013 · General Hospital

Device Facts

• Record ID: K131524
• Device Name: PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
• Applicant: Proteus Digital Health, Inc.
• Product Code: OZW · General Hospital
• Decision Date: Jun 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6305
• Device Class: Class 2

Indications for Use

The Proteus® Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

Device Story

Proteus Patch is a wearable sensor collecting heart rate, activity, body angle, and ingestion events; ingestible sensor (pill) communicates via volume conduction upon stomach arrival. Patch stores and wirelessly transmits data to general computing device for display. Used in clinical/research settings for unattended data collection; enables healthcare providers to analyze event-associated physiological metrics. Benefits include objective tracking of medication adherence and physiological response to therapy.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing. Bench testing included validation of three-axis accelerometer against known acceleration, heart rate quantification using modified Hamilton-Tompkins algorithm (per ANSI/AAMI EC 13), and ingestible sensor activation/lifetime testing.

Technological Characteristics

Wearable ovoid patch (102mm x 56mm x 10mm, 11g) with LiMn coin cell battery. Sensing: biopotential low-frequency amplifier (heart rate), accelerometer (activity/body angle), biopotential high-frequency amplifier (impedance), bio-galvanic ingestible circuit (ingestion). Connectivity: wireless transmission to general computing device. Software: modified Hamilton-Tompkins algorithm for heart rate.

Indications for Use

Indicated for ambulatory patients requiring recording of physiological and behavioral metrics, including heart rate, activity, body angle, and ingestion events, for clinical and research applications.

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 (K131009)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Proteus Digital Health. The logo is in black and white and features the word "proteus" in a stylized font. Below the word "proteus" is the phrase "DIGITAL HEALTH" in a smaller font. The logo is simple and clean, and it conveys a sense of innovation and technology.

JUN 2 3 2013

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## 510(k) Summary

Submitted by: Address:

Telephone: Facsimile: Contact Name:

Proteus Digital Health Inc. 2600 Bridge Parkway, Suite 101 Redwood City, CA, 94065 650 - 637 - 6158 650 - 362- 1860 Zahedeh Hatamkhany zhatamkhany(@proteusdh.com

Date Submitted:

May 24, 2013

## Name of Device

Trade name: Common name: Classification name: Proteus® Patch Including Ingestible Sensor Ingestible Event Marker Ingestible Event Marker (21 CFR 880.6305, Product Code OZW, DXH)

## Unmodified Device

Proteus® Patch Including Ingestible Sensor (K131009) .

### General Device Description

The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped user-logged events generated by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch. The Patch stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.

Proteus Digital Health, Inc.

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K131524 P2/4

## Intended Use

The Proteus® Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

# Physical Characteristics

| Parameter | Value |
|-------------------------|---------------------------------------|
| <b>The Patch</b> | |
| Shape | One-piece: ovoid |
| Size | 102mm x 56mm x 10mm |
| Weight | 11g |
| Battery type | Lithium Manganese (LiMn) Coin<br>Cell |
| Moisture susceptibility | Water-resistant |
| Memory | 4 MB |
| Storage temperature | Room Temperature |
| Relative humidity | Ambient |
| <b>The Pill</b> | |
| Shape | Round |
| Size | 6.5mm x 2.0mm |
| Weight | 80mg |

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K131524

P3/4

# Technological Characteristics

| Parameter | Sensor Technology | Method |
|---------------------------|---------------------------------------------|--------------------------------------------------|
| Heart rate | Biopotential low-frequency amplifier | Digitized R wave |
| Activity | Accelerometer | Digitized accelerometer output |
| Body angle | Accelerometer | Double integration of accelerometer output |
| Manual event logging | Patient activated button | Digital pulse |
| Inter-electrode impedance | Biopotential high-frequency amplifier | Digitized impedance from small auxiliary current |
| Ingestible Event Marker | Bio-galvanically powered ingestible circuit | Volume conduction communication |

# Summary of Non-Clinical Performance Data

The three-axis accelerometer provided motion and angle relative to gravity 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 modified Hamilton-Tompkins algorithm, tested using guidelines set forth in the ANSI/AAMI EC 13 standard.

The Ingestion 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 device.

## Conclusion

Proteus Digital Health, Inc.

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K131524

P4/4

Based on technological characteristics, risk evaluation, and design verification of the Proteus Patch Including Ingestible Sensor, Proteus Digital Health believes that the product is safe and effective, and is substantially equivalent to predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized, flowing lines representing the body and wings.

June 23, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Proteus Digital Health. Inc. Mr. Zahedeh Hatamkhany Cmc Regulatory-Combination Products 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 US

Re: K131224

> Trade/Device Name: Proteus Patch including Ingestible Sensor Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW, DXH Dated: May 24, 2013 Received: May 28, 2013

Dear Mr. Zahedeli Hatamkhany:

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

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Page 2 - Mr. Zahedeh Hatamkhany

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Bram D.Zuckerman -S**

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

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# K131524

# Indications for Use Statement

- 510(k) Number (if known)
Proteus® Patch including Ingestible Sensor Device Name

Indications for Use

The Proteus* Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

Prescription Use _ X (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)

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