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

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) .
. 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) ●

AI/ML Overview

The provided document is a 510(k) premarket notification letter and summary for the Optum TeleHealth Application. It describes a software application designed to collect, display, and transmit vital sign measurements for retrospective monitoring. As such, it is a data handling and transmission device, not a diagnostic or prognostic medical imaging AI device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance as typically expected for a medical imaging AI device. Specifically, it does not include:

A table of acceptance criteria with reported device performance (e.g., sensitivity, specificity, AUC).
Details on sample size, data provenance, ground truth establishment, or expert involvement for a test set designed to evaluate diagnostic or prognostic performance.
Information on MRMC studies or standalone algorithm performance.

Instead, the document focuses on:

Indications for Use: Retrospective monitoring of vital signs (noninvasive blood pressure, pulse rate, weight, temperature, blood glucose). It explicitly states it's not intended for emergency use or real-time monitoring.
Technological Characteristics: How it collects data (manual input, Bluetooth from external devices) and transmits it to a central repository.
Predicate Devices: Claiming substantial equivalence to a previously cleared Optum TeleHealth Application (K130971).
Pre-Clinical Testing: A generic statement that "Bench testing, including software validation, was performed to ensure that the product works as intended." and "Results of bench testing show that the product is safe, and effective for use." This implies functional verification and validation of the software, rather than clinical performance evaluation against a diagnostic ground truth.

In summary, this device's function is data aggregation and transmission, not medical image analysis or diagnosis. The typical performance metrics and study designs (like MRMC, standalone performance, or detailed ground truth establishment for diagnostic accuracy) are not applicable or described for this type of device in the provided document.

Summary

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Public Health Service

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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

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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)

K171406

Device Name

Optum TeleHealth Application

Indications for Use (Describe)

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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Manufacturer Name	OptumHealth Care Solutions, Inc.
Address	1100 King StreetBulding 6, Suite 300Rye 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 TeleHealthApplication	OptumHealth CareSolutions, Inc.	K130971

Description of the Device

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) .

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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.

Regulation Number and Section

§ 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).