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.
The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart tate, 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 stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary does not explicitly state formal "acceptance criteria" with specific thresholds for performance. Instead, it describes general methods for validation and testing. Therefore, the table below interprets the "acceptance criteria" as the method of validation itself rather than a numerical threshold, and the "reported device performance" as the statement of successful validation.
| Parameter | Acceptance Criteria (Method of Validation) | Reported Device Performance |
|---|---|---|
| Proteus Patch | ||
| Heart Rate | Biopotential low-frequency amplifier: Quantified by measuring R-wave frequency based on a modified Hamilton-Tompkins algorithm, tested using ANSI/AAMI EC 13 standard guidelines. | "The biopotential low-frequency amplifier was used to quantify heart rate... tested using guidelines set forth in the ANSI/AAMI EC 13 standard." (Implies successful testing). |
| Activity / Body Angle | Three-axis accelerometer: Validated against a known acceleration applied against each of its three axes. | "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." (Implies successful validation). |
| Manual Event Logging | Patient activated button: Digital pulse. (No explicit validation method described beyond the mechanism). | (No explicit performance reported, but the mechanism is described). |
| Inter-electrode Impedance | Biopotential high-frequency amplifier: Digitized impedance from small auxiliary current. (No explicit validation method described beyond the mechanism). | (No explicit performance reported, but the mechanism is described). |
| Ingestible Sensor | ||
| Activation Time & Lifetime after Activation | Tested for activation time and lifetime after activation. | "The Ingestion Sensor was tested for activation time and lifetime after activation." (Implies successful testing). |
| Bio-galvanically powered ingestible circuit | Volume conduction communication. (No explicit validation method described beyond the mechanism). | (No explicit performance reported, but the mechanism is described). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for test sets used for the individual performance validations. It mentions testing methods but not the number of subjects or items tested.
The data provenance is not specified (e.g., country of origin, retrospective/prospective). This is a non-clinical evaluation, so "patients" might not have been involved in all tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes technical device validation against standards or known inputs (e.g., "known acceleration"). It does not involve human expert interpretation of data to establish ground truth in the way a diagnostic AI system would. Therefore, this information is not applicable or provided.
4. Adjudication Method for the Test Set
Not applicable, as this is a technical validation against established standards and known physical inputs, not a subjective interpretation requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document states: "No additional clinical data were required to confirm substantial equivalence to predicate device." This indicates the device was cleared based on non-clinical performance and technological characteristics in comparison to a predicate, not through a study involving human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The performance data described (heart rate algorithm, accelerometer validation, ingestion sensor testing) are inherently "standalone" in the sense that they are assessing the device's technical capabilities without a human-in-the-loop for the primary validation. The device's overall intended use does involve data collection for clinical and research applications, implying potential future human interpretation, but the core performance described here is the device's ability to accurately log these metrics.
7. The Type of Ground Truth Used
The ground truth used for validation was primarily:
- Established industry standards: For heart rate, "guidelines set forth in the ANSI/AAMI EC 13 standard."
- Known physical inputs: For activity/body angle, "a known acceleration applied against each of its three axes."
- Device-specific measurements/specifications: For the ingestion sensor, "activation time and lifetime after activation" would be measured against the sensor's designed parameters.
8. The Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning. The device utilizes algorithms (e.g., modified Hamilton-Tompkins for R-wave frequency) that would have been developed and potentially trained previously, but the details of such training (including sample size) are not provided or relevant to this 510(k) summary, which focuses on validation rather than algorithm development.
9. How the Ground Truth for the Training Set Was Established
As no training set is discussed, this information is not provided.
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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 bold, sans-serif 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.
FEB - 7 2014
510(k) Summary
Submitted by: Proteus Digital Health Inc. Address: 2600 Bridge Parkway, Suite 101 Redwood City, CA, 94065 Telephone: (650) 637-6109 Facsimile: (650) 362-1860
Contact Name:
、
Jafar Shenasa ishenasa@proteusdh.com
Date Submitted:
October 21, 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 tate, 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 stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.
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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 telative 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.
| Parameter | Values | |
|---|---|---|
| The Patch | ||
| Shape | One-Piece Form Factor:(Cleared under K131524) Two-Piece Form Factor:(Modified device) | |
| Shape | One-piece: ovoid | Two-piece: Rectangular |
| Size | 102mm x 56mm x 10mm | 98mm x 42mm x 11mm |
| Weight | 11g | 16 g |
| Battery type | Lithium Manganese(LiMn) Coin Cell | Lithium Manganese(LiMn) Coin Cell |
| Moisture susceptibility | Water-resistant | Water-resistant |
| Memory | 4 MB | 16 MB |
| Storage temperature | Room Temperature | Room Temperature |
| Relative humidity | Ambient | Ambient |
| The Pill | ||
| Shape | Round | |
| Size | 6.5mm x 2.0mm | |
| Weight | 80mg | |
| Shape | Round |
Physical Characteristics
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Technological Characteristics
3
| Parameter | Sensor Technology | Method |
|---|---|---|
| Heart rate | Biopotential low-frequency amplifier | Digitized R wave |
| Activity | Accelerometer | Digitized accelerometer output |
| Body angle | Accelerometer | Double integration ofaccelerometer output |
| Manual event logging | Patient activatedbutton | Digital pulse |
| Inter-electrodeimpedance | Biopotential high-frequency amplifier | Digitized impedance from smallauxiliary current |
| Ingestible EventMarker | Bio-galvanicallypowered ingestiblecircuit | Volume conductioncommunication |
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
Based on technological characteristics, risk evaluation, and design verification of the Proteus
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Patch Including Ingestible Sensor, Proteus Digital Health, Inc. believes that the product is safe and effective, and is substantially equivalent to predicate device.
Proteus Digital Health, Inc.
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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 a stylized symbol that resembles an abstract human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2014
Proteus Digital Health, Inc. Jafar Shenasa 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 US
Re: K133263
Trade/Device Name: Proteus Patch, Proteus Ingestible Sensor (accessory) Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW, DXH Dated: January, 08, 2013 Received: January, 09, 2013
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
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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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P: Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) K133263 Number (if known)
Device Name Proteus® Patch including Ingestible Sensor
The Proteus Patch is a miniaturized, wearable data-logger for Indications ambulatory recording of physiological and behavioral metrics such as for Use 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 _____________________________________________________________________________________________________________________________________________________________ (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)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.07
09:27:41 '-05'00'
§ 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.