(26 days)
Not Found
No
The document describes a data logger and sensor system that collects physiological and behavioral metrics. It mentions a specific algorithm (modified Hamilton-Tompkins) for heart rate calculation, but there is no mention of AI, ML, or related concepts like training/test sets, which are typically associated with AI/ML development and validation.
No.
The document states that the device is a "miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics." Its purpose is to collect data for "clinical and research applications," and it enables "unattended data collection." There is no indication that it provides any form of therapy or treatment; it only records data.
No
The device is described as a data-logger for recording physiological and behavioral metrics for clinical and research applications. It collects and stores data but does not perform diagnostic interpretations of that data.
No
The device description explicitly states it is a "body-worn sensor" and a "miniaturized, wearable data-logger," indicating it is a physical hardware device, not solely software. It also mentions an "Ingestible Sensor accessory."
Based on the provided information, the Proteus Patch is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as a "wearable data-logger for ambulatory recording of physiological and behavioral metrics." It focuses on collecting data from the body (heart rate, activity, body angle, swallowed sensor events).
- Device Description: The description reinforces this by detailing how the device collects data from the body and the ingested sensor.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Proteus Patch does not perform this function. It collects data in vivo (within the body) or from a sensor that is ingested.
- Performance Studies: The performance studies described focus on validating the accuracy of the accelerometer, heart rate measurement algorithm, and the ingested sensor's function. These are not typical performance studies for an IVD device, which would involve evaluating the accuracy of measurements on biological specimens.
- Predicate Devices: The predicate devices listed (Proteus Personal Monitor, Raisin™ Personal Monitor) are also described as personal monitors or data loggers, not IVD devices.
In summary, the Proteus Patch is a wearable physiological and behavioral data collection device, not a device used for testing biological specimens outside the body.
N/A
Intended Use / 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 heart rate, activity, and body position is desirable.
Product codes (comma separated list FDA assigned to the subject device)
OZW, DXH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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
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'