(98 days)
No
The summary describes a software application for collecting, displaying, and transmitting vital signs. There is no mention of AI or ML being used for analysis, interpretation, or any other function. The analysis is described as being performed by clinicians.
No.
The device is strictly for monitoring and collecting vital signs, and explicitly states it is "not intended for emergency use or real-time monitoring," which implies it does not provide therapy or treatment.
No
The Optum TeleHealth Application is designed to collect, display, and transmit vital signs for retrospective monitoring and analysis by clinicians. It explicitly states, "The Optum TeleHealth Application is not intended for emergency use or real-time monitoring." While it handles vital sign data, its function is for data management and review, not for making an initial diagnosis or actively informing immediate clinical decisions for a specific condition.
Yes
The device is described as a "software application" and "client/server software application." While it interacts with external hardware devices for data collection, the core functionality and the device being cleared is the software itself, which collects, displays, and transmits data. The configurations listed are software-based (stand-alone applications, pre-loaded software).
Based on the provided text, the Optum TeleHealth Application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Optum TeleHealth Application's Function: The Optum TeleHealth Application collects, displays, and transmits vital sign measurements (blood pressure, pulse rate, weight, temperature, and blood glucose) obtained from external medical devices or manual input. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to "retrospectively monitor vital signs" and for "review, and analysis by clinicians." This is focused on managing and reviewing physiological data, not on analyzing biological samples.
Therefore, the Optum TeleHealth Application falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.
The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.
The client application is available in three configurations:
- stand-alone application for both Android and iOS operating systems
- pre-loaded on an Android tablet
Product codes
DRG, DXN, DOA
Device Description
The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians. The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android devices (OS 4.0 and higher) and Apple devices (iOS 9 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data.
The client application is available in two configurations:
- stand-alone application for both Android and iOS operating systems .
- . pre-loaded on an Android tablet
The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, including, but not limited to:
- A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217) .
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
Clinicians (for review and analysis), patient (for data input and viewing)
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
Bench testing, including software validation, was performed to ensure that the product works as intended.
Summary of Performance Studies
Bench testing, including software validation, was performed to ensure that the product works as intended. Results of bench testing show that the product is safe, and effective for use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K043217, K090395, K092106, K081285
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing to the right, with a symbolic representation of a parent cradling a child.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2017
United Health Group Inc. Donald Matthews Associate Director Quality and Regulatory 1100 King Street, Building 6, Suite 300 Rye Brook, New York 10573
Re: K171406
Trade/Device Name: Optum TeleHealth Application Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DXN, DOA Dated: July 26, 2017 Received: July 27, 2017
Dear Donald Matthews:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
M.A. Hillebrenner
for_
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Optum TeleHealth Application
Indications for Use (Describe)
The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.
The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.
The client application is available in three configurations:
- · stand-alone application for both Android and iOS operating systems
· pre-loaded on an Android tablet
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Manufacturer Name | OptumHealth Care Solutions, Inc. |
|---|---|
| Address | 1100 King Street |
| Bulding 6, Suite 300 | |
| Rye Brook, NY 10573 | |
| Contact Name | Donald J. Matthews |
| Title | Associate Director Quality and Regulatory |
| Phone Number | 914-933-4715 |
| Fax Number | 914-933-4704 |
| Date Prepared | 25 April 2017 |
| Device Proprietary Name | Optum TeleHealth Application |
| Device Common or Usual Name | TeleHealth Application |
| Classification Name | Transmitters and Receivers, Physiological Signal, |
| Radiofrequency | |
| Classification Code | DRG |
| Regulation Number | 870.2910 |
Predicate Devices:
Substantial equivalence is claimed to the following devices in terms of design, technological characteristics, and intended use.
| Name of Device | Manufacturer | 510(k) Number |
|---|---|---|
| Optum TeleHealth | ||
| Application | OptumHealth Care | |
| Solutions, Inc. | K130971 |
Description of the Device
The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians. The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android devices (OS 4.0 and higher) and Apple devices (iOS 9 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data.
The client application is available in two configurations:
- stand-alone application for both Android and iOS operating systems .
- . pre-loaded on an Android tablet
The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, including, but not limited to:
- A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217) .
4
OptumHealth Care Solutions, Inc. K171406
- . A&D Engineering Inc., UC-321PBT Weight Scale (510(k) exempt)
- TaiDoc Technology Corporation, Fora W310 Weight Scale (510(k) exempt) .
- . TaiDoc Technology Corporation, Fora IR20b Ear Thermometer (K090395)
- TaiDoc Technology Corporation, Fora P20 Blood Pressure Monitor (K092106) ●
- Nonin Medical Inc Onyx II Model 9560 Finger Pulse Oximeter (K081285) ●
Intended Use/Indications for Use
The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.
The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.
The client application is available in two configurations:
- . stand-alone application for both Android and iOS operating systems
- . pre-loaded on an Android tablet
Technological Characteristics
The client application obtains data via manual data input, or will automatically retrieve stored data from the assigned external biometric measuring devices via Bluetooth communication. Data is transmitted to the server over the internet using standard communication protocols. The client application connects to the server to synchronize with clinician updates via a secure connection.
Pre-Clinical Testing
Bench testing, including software validation, was performed to ensure that the product works as intended.
Conclusion
The Optum TeleHealth Application is substantially equivalent to the predicate devices identified above in terms of design, technological characteristics, and intended use. Results of bench testing show that the product is safe, and effective for use.