OPTUM TELEHEALTH APPLICATION

{0}------------------------------------------------ OptumHealth Care Solutions, Inc. Traditional 510(k) | Manufacturer Name: | OptumHealth Care Solutions, Inc. | |------------------------------|---------------------------------------------------------------------| | Address: | 1100 King Street<br>Building 6, Suite 300<br>Rye Brook, NY 10573 | | Contact Name: | William H. Schofield | | Title: | Director of TeleHealth Operations | | Phone Number: | 914-933-4622 | | Fax Number: | 914-933-4704 | | Date Prepared: | May 27, 2013 | | Device Proprietary Name: | Optum TeleHealth Application | | Device Common or Usual Name: | TeleHealth Application | | Classification Name: | Transmitters and Receivers, Physiological<br>Signal, Radiofrequency | | Classification Code: | DRG | | Regulation Number: | 870.2910 | | Predicate Devices: | | ## 510(k) Summary: K130971 ### 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 | |---------------------------|----------------------|---------------| | Vignet TeleHealth Manager | Vignet Corporation | K113446 | | Honeywell HomMed | Honeywell HomMed LLC | K112858 | | Genesis Touch System | | | | Healthanywhere System | Healthanywhere, Inc. | K091220 | #### 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 tablets (Android OS 4.0 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. {1}------------------------------------------------ Optum TeleHealth Application OptumHealth Care Solutions, Inc. Traditional 510(k) ## 510(k) Summary: K130971 The client application is available in two configurations: - stand-alone application . r - 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, as listed below: - 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) . ### 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 . - 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. {2}------------------------------------------------ OptumHealth Care Solutions, Inc. Traditional 510(k) ## 510(k) Summary: K130971 #### 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. {3}------------------------------------------------ Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines or waves. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ・・ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 23, 2013 Optum Health Care Solutions, Inc. c/o Ms. Roshana Ahmed. MA. RAC OptumInsight (Canada) Inc. 4 Innovative Drive Dundas, ON L9H 7P3 CANADA Re: K130971 > Trade/Device Name: Optum TeleHealth Application Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG, DXN, DQA Dated: September 19, 2013 Received: September 20, 2013 Dear Ms. Ahmed: 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. {4}------------------------------------------------ Page 2 - Ms. Roshana Ahmed, MA, RAC 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm 1 15809.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/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. Sincerely yours, # Owen P. Faris -S for Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Optum TeleHealth Application OptumHealth Care Solutions, Inc. Traditional 510(k) ## Indications for Use K130971 510(k) Number: Device Name: Optum TeleHealth Application The Optum TeleHealth Application is a software application Indication for Use: 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 . - pre-loaded on an Android tablet . And/Or Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Digitally signed by Owen P. Farls -5 Date: 2013.10.23 10:21:48 -04'00'