The Proteus® Patch, also called the 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 heart rate, activity, and body position is desirable.

Device Description

Like the Proteus Personal Monitor (K113070), the Proteus 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 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 physiologic, event, accelerometry, and Ingestible Sensor data to a general computing device for display.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Proteus Patch including Ingestible Sensor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides functional descriptions and validation methods for different parameters, but does not present explicit, quantitative acceptance criteria in a table format. However, based on the Summary of Non-Clinical Performance Data, we can infer the tested characteristics and the type of validation performed.

Parameter	Acceptance Criteria (Inferred from Validation)	Reported Device Performance
Proteus Patch
Motion & Angle Relative to Gravity	"Validated against a known acceleration applied against each of its three axes." (Implies accurate measurement against known inputs)	Performed the validation testing. No specific quantitative performance data (e.g., accuracy percentages, error margins) are provided in this summary.
Heart Rate	"Tested using guidelines set forth in the ANSI/AAMI EC 13 standard." (Implies adherence to established medical device standards for ECG performance)	Performed the validation testing. No specific quantitative performance data is provided.
Ingestible Sensor
Activation time	N/A (Tested for and determined)	Performed the validation testing. No specific quantitative performance data is provided.
Lifetime after activation	N/A (Tested for and determined)	Performed the validation testing. No specific quantitative performance data is provided.

2. Sample Size Used for the Test Set and Data Provenance

The summary states:

"No additional clinical data were required to confirm substantial equivalence to predicate devices."
The "Summary of Non-Clinical Performance Data" describes laboratory testing.

Therefore, there appears to be no distinct clinical test set used for this 510(k) submission as no additional clinical data was required. The "testing" mentioned refers to non-clinical, laboratory-based validation.

Sample Size for Test Set: Not applicable for clinical data. For non-clinical validation, specific sample sizes for the accelerometer and Ingestible Sensor tests are not provided in this summary.
Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed by the manufacturer, Proteus Digital Health, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no additional clinical test set was used, and ground truth in this context would likely refer to clinical expert consensus. For the non-clinical tests:

For the accelerometer, ground truth was "known acceleration."
For the heart rate, the ANSI/AAMI EC 13 standard provides the reference for accurate ECG measurement.
For the ingestible sensor, activation time and lifetime would be objectively measured, not requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring human adjudication was utilized for this submission based on the provided information.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or submitted as part of this 510(k). The document explicitly states "No additional clinical data were required." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

This device does not involve an "algorithm only" or "AI" in the sense of image interpretation or diagnostic assistance. It's a data logger and sensor. The "non-clinical performance data" describes the validation of the device's sensing capabilities (accelerometer, heart rate measurement algorithm, ingestible sensor activation). These are standalone functional tests of the device components.

Heart Rate Algorithm Standalone Performance: The biopotential low-frequency amplifier and its accompanying algorithm (modified Hamilton-Tompkins) were "tested using guidelines set forth in the ANSI/AAMI EC 13 standard." This indicates a standalone validation of the algorithm's performance against a known standard.

7. The Type of Ground Truth Used

Accelerometer: "Known acceleration applied against each of its three axes." (Physics-based objective measurement)
Heart Rate: Adherence to "ANSI/AAMI EC 13 standard" which provides criteria for accurate ECG measurement, implying a reference standard for ground truth.
Ingestible Event Marker: Objective measurement of "activation time and lifetime after activation."

8. The Sample Size for the Training Set

The document does not mention any "training set." This type of device (data logger, physiological sensor, ingestible event marker) typically undergoes engineering verification and validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for machine learning.

Summary

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K131009 P 1/4

Image /page/0/Picture/1 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, sans-serif font. The logo is simple and modern, and it conveys a sense of innovation and technology.

MAY 0 7 2013

510(k) Summary

Proteus Digital Health Inc.

Redwood City, CA, 94065

2600 Bridge Parkway, Suite 101

Jafar Shenasa, jshenasa@proteusdh.com

Submitted by: Address:

Telephone: Facsimile: Contact Name:

Date Submitted:

April 10, 2013

650 - 637 - 6109

650 - 362- 1860

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)

Unmodified Devices

Proteus Personal Monitor (K113070)
Raisin™ Personal Monitor (K093976)

General Device Description

Proteus Digital Health, Inc.

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Intended Use

The Proteus Patch, also called the 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
The Patch
Shape	One-piece: ovoid
Size	101mm x 53mm x 13mm
Weight	16g
Battery type	Lithium Polymer
Moisture susceptibility	Waterproof
Memory	4 MB
Storage temperature	Room Temperature
Relative humidity	Ambient
Ingestible Sensor
Shape	Round
Size	6.5mm x 2.0mm
Weight	80mg

Proteus Digital Health, Inc.

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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 accelerometeroutput
Manual event logging	Patient activatedbutton	Digital pulse
Inter-electrodeimpedance	Biopotential high-frequency amplifier	Digitized impedance from smallauxiliary current
Ingestible Event Marker	Bio-galvanicallypowered ingestiblecircuit	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 devices.

Proteus Digital Health, Inc.

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Conclusion

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 devices.

Proteus Digital Health, Inc.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be three overlapping human figures or abstract shapes, possibly representing people or services provided by the department. The logo is printed in black and white.

May 7, 2013

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

Protues Digital Health, Inc Jafar Shenasa, M.Sc., RAC Director, Regulatory Affairs 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065

Re: K131009

Trade/Device Name: Proteus Patch including Ingestible Sesnsor Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW, DXH Dated: April 10, 2013 Received: April 11, 2013

Dear Mr. 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. Ilisting 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. Jafar Shenasa

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/Reporta@roblem/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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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

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K131009

Indications for Use Statement

510(k) K131009 Number (if known)

Device Name Proteus® Patch including Ingestible Sensor

Indications The Proteus® Patch, also called the Patch, is a miniaturized, wearable for Use 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 heart rate, activity, and body position is desirable.

Prescription Use X (Per 21 CFR 801.109)

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)

Owen P. Faris -S
2013.05.07 09:46:09
04'00'

Regulation Number and Section

§ 880.6305 Ingestible event marker.

(a)
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.(b)
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.