AMBIO REMOTE HEALTH MONITORING SYSTEM

{0}------------------------------------------------ # 510(k) SUMMARY | 510(k) Owner: | Arrayent Health LLC /dba Ambio Health | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Kevin Jones, CEO | | Date Summary Prepared: | March 15, 2012 | | Device: | | | Trade Name: | Ambio Remote Health Monitoring System | | Common/Classification Name: | Remote Patient Monitoring System | | Classification: | Class II | | Predicate Devices: | K062377 MedApps 2.0 - Remote Patient Monitoring System<br>K111932 Positive ID - iglucose ^tm Device, Secure Database, Diabetes Management Portal<br>K080798 Intel Health Guide PHS6000 | | Intended Use: | The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters, the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and for achieving reading targets. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed. | | | The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors. | : {1}------------------------------------------------ The System consists of: System Description: (1) Ambio Wireless Connectors (Wireless Connectors): The Wireless Connector is an electronic device that plugs into the USB port of compatible Blood Pressure Monitors and Blood Glucose Monitors to read the log, encrypt the data, and wirelessly transmit the data to the Ambio Gateway. Readings are sent automatically based on a schedule stored in the Wireless Connector or, the User can push the button on the Wireless Connector to initiate reading the Monitor log and transferring the data. - (2) Ambio Scale The Ambio Scale is a stand on digital weight scale with an embedded Ambio Wireless Connector. When the User takes a weight reading, it is then encrypted by the Ambio Wireless Connector and wirelessly transmitted to the Ambio Gateway. - (3) Ambio Gateway The Ambio Gateway is an electronic device that connects to the Patient's existing home Internet router using an Ethernet cable. The Ambio Gateway wirelessly receives encrypted data from the Ambio Wireless Connector and transmits it through the user's home broadband internet router to the Ambio Care Portal. (4) Ambio Care Portal The Ambio Care Portal is a secure, web based data base and software application that allows Users to review patient data collected from the described health devices using the Ambio Wireless Connector and Ambio Gateway. The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and achieving readings target. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed. {2}------------------------------------------------ ### K130676 pg. 3 of 6 Technological Characteristics: The operation of the System is the same as the predicate devices in all respects other than the wireless protocol and frequency used to communicate readings from the health meter / Wireless Connector to the Gateway. Predicate devices use Bluetooth (2.402 to 2.48 GHz) or GSM Cellular (850 / 900 / 1800 / 1950 MHz) as the wireless technology and the subject device uses the 900MHz (902 - 928MHz) band approved by the FCC for unlicensed communication equipment. | Attribute | MedApps<br>Remote<br>Patient<br>Monitoring<br>Device | IDEAL LIFE<br>Pod | Positive ID<br>Iglucose<br>System | Subject<br>Device<br>(Ambio<br>Health<br>Remote<br>Health<br>Monitoring<br>System) | |--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K112559 | K080538 | K111932 | | | Indications<br>of Use | Enables<br>healthcare<br>providers to<br>monitor and<br>manage<br>chronic<br>conditions of<br>patients<br>remotely<br>Flag readings<br>based on<br>specific<br>thresholds<br>being<br>exceeded.<br>Maintain<br>compliance<br>to schedules.<br>Graphic<br>trending. | Enables<br>people at<br>home and<br>healthcare<br>providers to<br>review and<br>evaluate<br>historical<br>blood<br>glucose,<br>weight and<br>blood<br>pressure test<br>results | Enables<br>people at<br>home and<br>healthcare<br>providers to<br>review and<br>evaluate<br>blood<br>glucose data<br>as an aid in<br>supporting<br>diabetes<br>management.<br>Graphic<br>trending. | Enables<br>people at<br>home and<br>healthcare<br>providers to<br>monitor and<br>manage<br>chronic<br>conditions<br>of patients<br>remotely<br>Flag<br>readings<br>based on<br>specific<br>thresholds<br>being<br>exceeded.<br>Maintain<br>compliance<br>to<br>schedules.<br>Graphic<br>trending. | | Intended use | Telemedicine<br>System | Same | Same | Same | | Intended<br>Users | Home users<br>and<br>Healthcare<br>Providers | Same | Same | Same | | Site of Use | Home, Clinic | Same | Same | Same | | Data<br>Collection<br>Software<br>Functionality | Transmit<br>data from<br>sensor<br>devices to<br>Central<br>Database | Same | Same | Same | | Communicati<br>on method of<br>hub with<br>Central<br>Server | Cellular | Internet or<br>Telephone<br>line | Cellular | Internet | | Types of<br>sensors<br>which can be<br>interfaced<br>(wired or<br>wirelessly) to<br>receiver hub | Medical<br>Devices<br>designed for<br>Home Use:<br>Glucose<br>Scale<br>Blood<br>Pressure<br>PulseOx | Medical<br>Devices<br>designed for<br>Home Use:<br>Glucose<br>Scale<br>Blood<br>Pressure | Medical<br>Device<br>design for<br>Home Use:<br>Glucose | Medical<br>Devices<br>designed<br>for Home<br>Use:<br>Glucose<br>Scale<br>Blood<br>Pressure | | Sensor<br>Software | Sensor<br>Software<br>unchanged | Same | Same | Same | | Implementa-<br>tion Method<br>of collecting<br>data from<br>sensors | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Wireless | Data cable | Data cable<br>(one end of<br>Wireless<br>Connector) | | Connectivity | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Wireless<br>(Bluetooth)<br>and Wired<br>SmartCable | Data cable | Wireless<br>(900 MHz -<br>other end of<br>Wireless<br>Connector) | | Communica-<br>tion method<br>of hub with<br>devices | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Cellular | Wireless<br>(900MHz) | | Communica-<br>tion Protocol | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Wireless<br>(Bluetooth)<br>and Wired<br>(tethered)<br>cables | Cellular | Wireless<br>(900MHz) | | Communica-<br>tion<br>Frequency | Bluetooth<br>2.402 to<br>2.480 GHz<br>GSM: 850 /<br>900 / 1800 /<br>1950 MHz | Bluetooth<br>2.402 to 2.48<br>GHz | GSM: 850 /<br>900 / 1800 /<br>1950 MHz | 900MHz<br>(902-928<br>MHz) | | Power<br>Source | Wall power<br>plug (120<br>VAC/50-60)<br>Rechargeable<br>Batteries in<br>HealthPAL | Wall power<br>plug (120<br>VAC/50-60) | Wall power<br>plug (120<br>VAC/50-60)<br>and<br>rechargeable<br>battery in<br>iGlucose | Wall power<br>plug (120<br>VAC/50-<br>60) and<br>coin cell<br>battery in<br>Wireless<br>Connector | | Visual<br>Feedback /<br>Display | LED Light<br>indicators | Same | Same | Same | | Communica-<br>tion with<br>Patients | Audio/visual<br>reading<br>feedback<br>from LED<br>light<br>indicators &<br>audio tones;<br>Interactive<br>Voice<br>Response<br>(IVR) system<br>for patient<br>contact | Data is<br>viewed in a<br>web-based<br>application;<br>sent via<br>email, SMS<br>text and fax. | Data is<br>viewed in a<br>web-based<br>application;<br>sent via<br>email, SMS<br>text and fax. | Data is<br>viewed in a<br>web-based<br>application;<br>sent via<br>email, SMS<br>text and<br>IVR. | {3}------------------------------------------------ # K130676 Pg. 4 of 6 K150076 pg. 4 of 6 {4}------------------------------------------------ ## K130676 pg. 5 of 6 #### Performance Data: Non-clinical Testing The submitted system was found to be compliant to the following standards based on testing performed by Intertek Testing Services: - 1. IEC 60601-1 Issue1988/12/01 Ed:2 Medical Electrical Equipment Part 1: General Requirements for Safety; (Amd. 1-1991) (CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995) - 2. IEC 60601-1-1 Issued:2000/12/01 Ed:2 Medical Electrical Equipment -Part 1-1: General Requirements for Safety - Collateral Standard: Safety K130676 P 6/6 - 3. Requirements for Medical Electrical Systems {5}------------------------------------------------ K130676 pg. 6 of 6 - 4. IEC 60601-1-4 Issue:2000/04/01 Ed:1.1 Medical Electrical Equipment -Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems; Edition 1:1996 Consolidated - 5. IEC/EN 60601-1-2 (Ed. 2): 2001 +A1: 2004 Medical electrical equipment, Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. with Amendment ! : 1999 The submitted system has undergone Ambio Health's design control verification and validation testing. Ambio Health validation testing includes testing of all executable code and functionality and confirmation that all identified risks have been adequately addressed by software functionality, the user interface, documentation or the User Guide. Ambio Health System verification and validation activities as part of the design control process include testing of all Design Specifications based on risk analysis and verification plans. Ambio Health System test plan execution ensures each type of user accessory medical device (glucose, blood pressure, scale) works with the Ambio Wireless Connector and Gateway components and the Ambio Care Portal software. The output of these design control verification analysis documents Ambio Remote Health Monitoring System shall meet its requirements and design specifications as intended. Arrayent Health used its Risk Management Plan to perform risk analysis regarding human factors for usability to determine that there are no significant risks. The performance data discussed in this 510(k) application demonstrate that the Conclusions: Ambio Health - Remote Patient Monitoring System is as safe and effective, as the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white. #### T OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002 July 8, 2013 Arrayent Health LLC d/b/a Ambio Health c/o Mr. Kevin Jones CEO 1266 E Main Street Stamford, CT 06902 Re: K130676 Trade/Device Name: Ambio Remote Health Monitoring System Regulatory Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: II (two) Product Code: 74 DRG Dated: May 13, 2013 Received: May 14, 2013 Dear Mr. Jones: 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. Ilsting 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 {7}------------------------------------------------ #### Page 2 - Mr. Kevin Jones 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 (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/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/Resourcesfor You/Industry/default.htm. Sincerely yours, # Owen P. Faris -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # K130676 #### Indications for Use 510(k) Number Not assigned. (if known): Device Name: Ambio Remote Health Monitoring System The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters; the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their caregivers ("Users") to view readings, set reminders to take meter readings and pills, set reading thresholds which will trigger alert messages and set who will get reminder and alert messages. Reading history can be printed or exported. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. The System also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available. The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (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) Owen 2013. -04'0 Owen P. Faris -S 2013.07.08 16:15:20 -04'00'