← Product Code [OZW](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OZW) · K131009 # PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (K131009) _Proteus Digital Health, Inc. · OZW · May 7, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OZW/K131009 ## Device Facts - **Applicant:** Proteus Digital Health, Inc. - **Product Code:** [OZW](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OZW.md) - **Decision Date:** May 7, 2013 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.6305 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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. ## Device Story Proteus Patch is a wearable data-logger collecting heart rate, activity, body angle, and ingestible sensor events. Ingestible sensor, embedded in a tablet, activates in the stomach, communicating via volume conduction to the patch. Patch stores and wirelessly transmits data to a general computing device for display. Used in clinical and research settings for unattended monitoring. Healthcare providers review transmitted data to assess patient physiological and behavioral metrics, supporting clinical decision-making and patient management. ## Clinical Evidence No clinical data required. Bench testing validated three-axis accelerometer performance, biopotential amplifier heart rate quantification using a modified Hamilton-Tompkins algorithm (per ANSI/AAMI EC 13), and ingestible sensor activation/lifetime. ## Technological Characteristics Wearable ovoid patch (101x53x13mm, 16g) with Lithium Polymer battery. Sensing: biopotential low-frequency amplifier (heart rate), accelerometer (activity/body angle), biopotential high-frequency amplifier (impedance), and bio-galvanically powered ingestible circuit. Connectivity: wireless transmission to general computing device. Memory: 4MB. Software: modified Hamilton-Tompkins algorithm for R-wave detection. ## Regulatory 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 Personal Monitor ([K113070](/device/K113070.md)) - Raisin™ Personal Monitor ([K093976](/device/K093976.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 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 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. Proteus Digital Health, Inc. {1}------------------------------------------------ P2/4 ## 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. {2}------------------------------------------------ K131009 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 devices. Proteus Digital Health, Inc. {3}------------------------------------------------ # K131000 P 4/4 # 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. 6-4 {4}------------------------------------------------ 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 {5}------------------------------------------------ #### 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 {6}------------------------------------------------ #### 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) 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) Owen P. Faris -S 2013.05.07 09:46:09 04'00' --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OZW/K131009](https://fda.innolitics.com/submissions/GU/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OZW/K131009) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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