(422 days)
Not Found
No
The summary describes a kiosk that measures basic vital signs (weight, blood pressure, heart rate) and displays the results. There is no mention of AI, ML, or any advanced data processing beyond simple measurement and display. The performance studies focus on safety and software validation, not algorithmic performance.
No.
The device's stated purpose is to measure, not treat. It provides supplemental data for a physician, but does not perform any therapeutic intervention itself.
No
The "Intended Use / Indications for Use" section explicitly states, "The kiosk is not intended to be a diagnostic device and does not perform any diagnoses."
No
The device description explicitly states it is a "multi-functional unit which measures a person's weight, blood pressure and heart rate" and describes physical components like a "touch screen LCD computer screen" and the user being "seated during the entire operation." This indicates it is a physical device with integrated hardware for measurement and display, not solely software.
Based on the provided information, the EngagementHealth Kiosk is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The EngagementHealth Kiosk measures physical parameters directly from the user (weight, blood pressure, heart rate) without requiring any bodily specimens.
- The Intended Use explicitly states it is "not intended to be a diagnostic device and does not perform any diagnoses." This directly contradicts the purpose of an IVD device.
- The device provides "supplemental data when consulting a professional physician," indicating it's a tool for gathering information, not for performing diagnostic tests on biological samples.
Therefore, the EngagementHealth Kiosk falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person's weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.
Product codes
DXN
Device Description
The EngagementHealth Kiosk is a device which provides a method for identifying a person's systolic and diastolic blood pressure, pulse rate, weight and displays the results onto the touch screen LCD computer screen. The individual using the device is seated during the entire operation of the device for accurate blood pressure readings.
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
The general public, within public or corporate environments.
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
Clinical testing is not required.
The EngagementHealth Kiosk has been tested and found to be in compliance with recognized safety standards.
The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like element above them, possibly representing an eagle or another bird of prey.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
EngagementHealth, LLC c/o Jorge Millan, Ph.D. Hialeah Technology Center 601 West 20 St. Hialeah, FL 33010
Re: K140360
Trade/Device Names: EngagementHealth Kiosk Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 25, 2015 Received: March 2, 2015
Dear Dr. Millan:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
Page 2 – Jorge Millan, Ph.D.
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/Resourcesfor You/Industry/default.htm. 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.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/ResourcesforYou/Industry/default.htm
Sincerelv vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K140360
Indications for Use
510(k) Number (if known):
Device Name:
EngagementHealth Kiosk
Indications for Use:
The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person's weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
3
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ _ K140360
Submitter
224 North Des Plaines Street Suite 401 Chicago, IL 60661 Registration #: To be applied for
Official correspondent :
Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260
Date Prepared:
February 27, 2015
Device name and classification:
- Device Name: EnqagementHealth Kiosk ●
- Common Name: ●
- Classification Name: ●
System, measurement, noninvasive blood pressure. Classification Number:
Kiosk for Measurement of Health Parameters
- 870.1130 DXN
- Product Code:
●
- Classification: Class II ●
4
Predicate Devices:
- PharmaSmart Inc. - PharmaSmart PS1000/PS1500/PS2000 Public Use Blood Pressure Monitor (K063137)
- . Stayhealthy Kiosk SH650-C (K123539)
- A & D Medical TM-2655 Digital Blood Pressure Monitor (K010828) .
Device Description:
The EngagementHealth Kiosk is a device which provides a method for identifying a person's systolic and diastolic blood pressure, pulse rate, weight and displays the results onto the touch screen LCD computer screen. The individual using the device is seated during the entire operation of the device for accurate blood pressure readings.
Indications for Use:
The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person's weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.
Effectiveness and Safety Contraindications:
Clinical Test
Clinical testing is not required
Non-clinical test:
The EngagementHealth Kiosk has been tested and found to be in compliance with recognized safety standards.
5
EngagementHealth Kiosk
The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
Comparison to the predicate device:
The subject device has similar technology characteristics and intended use as predicate devices legally marketed in the US.
Substantially Equivalent Determination:
EngagementHealth Kiosk is substantially equivalent in technological characteristics and intended use to legally marketed devices compared herein. Further, the EngagementHealth health kiosk is as safe, as effective and performs as well as the predicate devices.