Who is the manufacturer of MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

Medapps, Inc. filed the 510(k) submission for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K083862).

What is the FDA product code for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

Intel Health Guide PHS6000 (K080798); Confidant 2.5 (K072698); MedApps Remote Patient Monitoring System (D-PAL) (K062377).

Who can help prepare an FDA 510(k) submission like MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

K083862 · Medapps, Inc. · DRG · Jun 5, 2009 · Cardiovascular

Device Facts

Record ID	K083862
Device Name	MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
Applicant	Medapps, Inc.
Product Code	DRG · Cardiovascular
Decision Date	Jun 5, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2

Intended Use

The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient 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.

Device Story

MedApps 2.0 is a remote patient monitoring hub (HealthPAL) connecting to home-use medical devices (glucose meters, scales, BP monitors, pulse oximeters) via Bluetooth or wired cables. It collects, stores, and displays physiological data on an OLED screen and transmits it to a secure server (HealthCOM) via cellular/wireless networks. Healthcare professionals review data and set thresholds for alerts. An Interactive Voice Response (IVR) system provides automated patient reminders and educational messages. The system facilitates data transfer to PHR/EHR systems. Used in home settings by patients; monitored by clinicians in clinics. Benefits include improved patient adherence and remote oversight of chronic conditions without requiring real-time intervention.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included alpha testing of all executable code, functionality, and hazard mitigation. Operational performance data was generated by simulating a sophisticated user environment to confirm design specifications were met.

Technological Characteristics

System includes HealthPAL (OLED screen, M2M cellular chip, Bluetooth/wired interfaces), HealthLINK (docking), and HealthPOD (recharge/backup comms). Connectivity via GSM, CDMA, WiMax, Bluetooth, Zigbee, ANT, ULP. Power via wall plug or rechargeable batteries. Software manages data capture, transmission, and IVR scripts.

Indications for Use

Indicated for patients managing chronic conditions requiring remote monitoring of glucose, weight, blood pressure, or pulse oximetry. Contraindicated for patients requiring direct medical supervision or emergency intervention.

Regulatory Classification

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.

Predicate Devices

Intel Health Guide PHS6000 (K080798)
Confidant 2.5 (K072698)
MedApps Remote Patient Monitoring System (D-PAL) (K062377)

Related Devices

K124000 — MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM · Medapps Inc., Dba Alere Connect · Jul 30, 2013
K112559 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM · Medapps, Inc. · Dec 2, 2011
K132803 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK · Medapps Inc., Dba Alere Connect · Dec 12, 2013
K132930 — MYHEALTHPOINT TELEHEALTH MANAGER · Entra Health Systems · Apr 14, 2014
K111922 — VOCARE MYHEALTH TABLET · Vocare, Inc. · Dec 2, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ ### MedApps, Inc. 510(k) SUMMARY . K083862 P.1/7 PREMARKET NOTIFICATION 510(k) SUMMARY As required by 21 CFR §807.92(c) ### Submitter 510(k) Owner: MedApps, Inc. Owner / Operator: 10027842 Registration : 3005916763 7975 North Hayden Road, Suite A-200, Scottsdale, AZ 85258 Address: Telephone: 480-305-6323 480-393-1892 Fax Number: Contact Person: Kent Dicks Contact Person Title: President / CEO December 23, 2008 Date Prepared: ### Device Information | Trade Name: | MedApps 2.0 - Remote Patient Monitoring System | |------------------------|------------------------------------------------------------------------------------------------------| | Common Name: | Remote Patient Monitoring System | | Classification Status: | Class II per regulations 870.2910 | | Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency (21 CFR 870.2910. Product Code DRG) | #### LEGALLY MARKETED PREDICATE DEVICE A. Legally marketed predicate device are: Intel Health Guide PHS6000 K080798 K072698 Confidant 2.5 MedApps Remote Patient Monitoring System (D-PAL) K062377 #### B. DEVICE DESCRIPTION The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). {1}------------------------------------------------ K083862 p. 2/7 The HealthCOM system allows the patient to login and create a personal account. The patient can specify / authorize which Personal Health Record (PHR) or Electronic Health Record (EHR / EMR) they would like to send / view their data within, outside of the HealthCOM system. The MedApps 2.0 - Remote Patient Monitoring System uses MedApps Accessories that help the patient in usability of the product, including HealthLINK which docks the HealthPAL, and HealthPOD which connects to off the shelf medical devices via their data port to transmit data via wireless or RF technology (including, but not limited to bluetooth, zigbee, ANT, ULP, etc.). The MedApps 2.0 - Remote Patient Monitoring System consists of: (1) MedApps HealthPAL hardware: The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless, LED Lights to indicate activity, timer button to remind the patient to take their reading in X minutes, last reading button, volume up and down buttons. - (2) MedApps HealthPAL software application: The software application captures, stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform. The software application takes in additional information via the embedded wireless module from other medical devices that are wireless enabled, and that have been paired to the MedApps HealthPAL. The software application has many additional functions including: - Download of the users profile from the server to configure the . HealthPAL remotely. . - Ability to "talk" to the patient with verbal acknowledgments of . readings from all attached medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device. - Timer set that was activated by the user at a set timeframe to ● do whatever they wanted to be reminded to do. - Control the OLED screen to show certain information including, . battery status, volume level, transmission status, message waiting indicator, medical device last reading, activity icons / messages and more as it pertains to provide ease of use and easier adoption for the patient. - Battery charging, isolation circuits, and interfaces to individual . medical devices / protocols via the smart cables. {2}------------------------------------------------ ### MedApps, Inc. 510(k) SUMMARY K083862 p.3/7 - . For complete comparison of predicate devices see paragraph D - TECHNOLOGICAL CHARACTERISTICS SUMMARY table below. please reference Exhibit 08 - System Additionally, Requirements Specifications (FDA-SRS-8009) document for complete software / system functionality. - (3) MedApps HealthLINK hardware / software: The HealthLINK hardware / software plugs into off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, and transmit the data via wireless to a receiver that it is already paired with. This functionality was cleared in the MedApps D-PAL submission K062377 in July 2007. - (4) MedApps HealthPOD hardware / software: The HealthPOD hardware / software is an extension of the HealthPAL functionality that is outlined in this submission. HealthPOD acts as a "docking" station for the HealthPAL in order to recharge batteries, take in additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software), add a backup communication method via phone line (POTS line), and communicate via wireless to HealthPAL or additional HealthPODs. - (5) MedApps HealthCOM software application: The software application allows caregivers to set thresholds and review patient data on the secure HealthCOM website. The HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record (EHR or EMR). - (6) MedApps IVR software application: The software application calls the patient on any phone that is designated in their user profile, and executes an approved ("canned") script to gather information. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and many other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on parameters / thresholds set in the HealthCOM system. {3}------------------------------------------------ K083862 p. 4/7 #### INDICATIONS FOR USE C. The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient 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. | Feature | Intel Health Guide PHS6000 K080798 | Confidant 2.5 K072698 | MedApps Submission K083862 | |---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Indications of Use | Enables healthcare providers to monitor and manage chronic conditions of patients remotely | Same | Same | | Intended Use | Telemedicine System | Same | Same | | Intended Users | Home users and Healthcare providers | Same | Same | | Site of Use | Home (HealthPAL), Clinic (HealthCOM) | Same | Same | | Data Collection Software | Intel Care Management Suite Software | The Hermes Proprietary Software | MedApps Proprietary Software | | SUMMARY | | | K083862 | | Feature | Intel Health Guide PHS6000 | Confidant 2.5 | MedApps Submission | | | K080798 | K072698 | K083862 | | Data Collection Software Functionality | Transmit data from Sensor devices to Central Database | Same | Same | | Communication method of hub with Central Server | Via DSL or Phone Line Connection | Via Cellular Phone | Via Embedded Cellular Technology | | Types of sensors which can be interfaced (wired or wirelessly) to receiver hub | Medical Devices designed for Home: Glucose Scale Blood Pressure Pulse Ox Peak Flow | Medical Devices designed for Home: Glucose Scale Blood Pressure | Medical Devices designed for Home: Glucose Scale Blood Pressure Pulse Ox | | Maximum number and type of measurement devices that can be connected to the devices | Determined by vital sign devices that are designed for Home use, and have a data port. (Wireless or Wired) | Same | Same | | Maximum data throughput under worst case conditions | Multiple readings are stored on the medical devices and act as a backup if data needs to be re-sent to the server | Same | Same | | Time Delay in the processing of data collected and transmitted | Readings stored in the medical devices can be sent up to the server when the connection is restored. | Same | Same | | Implementation method of collecting data from sensors | Short range radio system using Bluetooth and Wired (tethered) cables. | Short range radio system using Bluetooth | Short range radio system using Bluetooth and Wired (tethered) cables. | | Sensor Software | Sensor Software unchanged | Same | Same | | Connectivity | Short range radio system using Bluetooth and Wired (tethered) cables. | Short range radio system using Bluetooth | Short range radio system using Bluetooth and Wired (tethered) cables. | | Communication method of hub with devices | Short range radio system using Bluetooth and Wired (tethered) cables. | Short range radio system using Bluetooth | Short range radio system using Bluetooth and Wired (tethered) cables. | | SUMMARY | | | | | Feature | Intel Health Guide PHS6000 K080798 | Confidant 2.5 K072698 | MedApps Submission K083862 | | Communications Protocol | Bluetooth V2.0 and Wired (Tethered) | Bluetooth V2.0 | Bluetooth V2.0 and Wired (Tethered) | | Communication Frequency | Bluetooth : 2.402 to 2.480 GHz | Bluetooth : 2.402 to 2.480 GHz GSM: 850 / 900 / 1800 / 1950 Mhz | Bluetooth : 2.402 to 2.480 GHz GSM: 850 / 900 / 1800 / 1950 Mhz | | Power Source | Wall power plug (120 VAC/50-60) | Wall power plug (120 VAC/50-60) and Rechargeable Batteries in Device | Wall power plug (120 VAC/50-60) and Rechargeable Batteries in Device | | Display | On devices and hub, and monitors connected to central server | Same | Same | | Communication with Patients | On screen display | Same | On screen display of Readings, Voice Output and Interactive Voice Response (IVR) | | Use of Thresholds / Algorithms for determining how Thresholds are set and changed | Thresholds are set by Healthcare professionals in Server Software | Same | Same | | Information presented to the user, if it is different from that presented by the measurement devices | On screen display | Same | On screen display of Readings, Voice Output and Interactive Voice Response (IVR) | | Messages and Instructions that can be sent to the User. | On screen display | Same | On screen display of Readings, Voice Output and Interactive Voice Response (IVR) | #### TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by D. 807.92(a)(6) {4}------------------------------------------------ : : 、 : . : . ・、 . . . . . . . : # EXHIBIT 02 : {5}------------------------------------------------ ## Data Collection: The 2 predicates and the MedApps solution connect to medical devices (designed for home use) via either through wired (cable) or wireless (bluetooth). The data is collected from the devices and sent up to the central server via various communication methods. # Telecommunication Platform to Central Server: Intel Health uses DSL connectivity (wired point of care), Confidant uses an off the shelf Cell Phone (Cellular), and MedApps uses an embedded Machine to Machine (M2M) module that transmits the data via cellular connectivity. {6}------------------------------------------------ **EXHIBIT 02** K083862 p.7/7 ## Patient Feedback Technology: On the 2 predicates and MedApps, data and messages are displayed on a screen for the patient to read and acknowledge. The MedApps solution also uses an Interactive Voice Response (IVR) system in order to call up the patient and ask them a question, or remind them to take their readings. #### Backend Data Storage: All systems (2 predicates and MedApps), have a backend system that allows data to be stored, and for Healthcare professionals to have the ability to monitor the patients data. #### NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as E. required by 807.92(b)(1) #### Non-Clinical Testing The submitted device has undergone significant verification and validation testing, Alpha validation testing included testing of all executable code and functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface, documentation or user SOP. Alpha validation activities included exhaustive validation scripts of all Detail Design Specifications (DDS), which was summarized and discussed to provide a preliminary record of performance data. Additionally, the submitter duplicated the operational environment of a sophisticated user and provided the complete record of those executed scripts as operational performance data. The output of these two performance data records documents that MedApps 2.0 - Remote Patient Monitoring System met its required requirements and design specifications as intended. #### F. SUBSTANTIAL EQUIVALENT The MedApps Remote Patient Monitoring System 2.0 is substantially equivalent to the predicate devices in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source and display method. #### G. SAFETY AND EFFICACY The MedApps Remote Patient Monitoring System 2.0 does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate its safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices. {7}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .. JUN ~ 5 2009 MedApps, Inc. c/o Mr. Kent Dicks President & CEO 7975 North Hayden Road, Suite A-200 Scottsdale, AZ 85258 Re: K083862 Trade/Device Name: MedApps 2.0 Remote Patient Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: March 31, 2009 Received: April 1, 2009 Dear Mr. Dicks: 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. 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 (reporting of medical {8}------------------------------------------------ ## Page 2 - Mr. Kent Dicks 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/ucm115809.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Dina R. Rohner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ | MedApps, Inc. | |----------------------------------| | STATEMENT OF INDICATIONS FOR USE | 510(k) Number: _K083862 Preparation Date: December 23, 2008 Device Name: ### MedApps 2.0 - Remote Patient Monitoring System Indications For Use: The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X Dunia R. James Division of Cardiovascular Devices 510(k) Number K083862