The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.

MedApps Inc., DBA Alere Connect Remote Patient Monitoring devices receive and store measurements collected from the described accessory devices, either wirelessly using short-range radio protocols (e.g. Bluetooth, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USB, serial, etc). Regardless of connectivity mode, the MedApps / Alere Connect monitoring devices do not alter the indications for use of the described peripheral accessory health devices.

MedApps / Alere Connect devices indicate successful or failed data reception and transmission with visual and audio feedback using a combination of any of the following: OLED Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps / Alere Connect devices store collected data and forward / transmit to server for access in HealthCOM via commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax).

Healthcare professionals, clinicians and other authorized personnel can review the transmitted information within the MedApps HealthCOM system, where they can review collected readings, establish parameters to Indicate readings exceptions to set thresholds, or trigger Interactive Voice Response (IVR) messages to the patient remotely to issue Information such as reminders (e.g. "We haven't received readings from you today, please take and send your readings") or possibly educational information for conditions such as diabetes, hypertension, CHF, etc. Additionally, HealthCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice.

The MedApps 2.0 (Alere Connect) - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Device Description

The MedApps 2.0 - Remote Patient Monitoring System consists of:

(1) HealthPAL hardware: The physical component of the 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 module, LED lights to indicate activity, timer button to assist patients with their reading schedule (i.e. remind them to take their reading in X minutes), last reading button, volume up and down buttons. The HealthPAL Model 105 contains a GSM cellular module while the HealthPAL Model 106 contains a CDMA cellular module.
(2) HealthHUB hardware / software: The HealthHUB hardware is an extension of the HealthPAL functionality. HealthHUB acts as a "docking" station for the HealthPAL in order to act as a conduit for the AC power adaptor connecting the electrical wall outlet to the HealthPAL providing power and battery charging capability. The Hubs also provide additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software). The HealthHUB model MA200 allows for multiple wired connections for accessory devices. HealthHUB Model 205 is specific for the HealthPAL MA105, and the HealthHUB 206 is specific for the HealthPAL MA 106 with both Hubs having one wired connector.
(3) HealthPAL firmware / software: The firmware captures data from commercially available health monitors, and stores and transmits the information to the HealthCOM server, via the embedded communication chip / platform. The firmware allows HealthPAL to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the MedApps HealthPAL. The firmware has many additional functions including: Download of user profiles from the server to configure HealthPAL remotely, Audio capability to deliver verbal announcement of readings and acknowledgment of data transmission, Timer capability, OLED screen displays information regarding the HealthPAL's status, Battery charging, isolation circuits, and interfaces to individual accessory medical devices / protocols via the smart cable.
(4) MobileLink (formally HealthAIR) hardware / software: AC020 MobileLink is a modified MA105 HealthPAL device. The physical component of the MobileLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, OLED screen to review the reading, and LED lights to indicate activity regarding the receiving and transmitting of collected data. Like the HealthPAL, MobileLink's firmware / software captures, data from commercially available retail health monitors, and stores and transmits information to the HealthCOM server, via the embedded communication chip / platform. The firmware allows MobileLink to receive information via wire, either standard USB or with a customized USB Smart Cable, from accessory medical devices. The firmware has many additional functions including: Download of user profiles from the server to configure MobileLink remotely, MobileLink's Audio feature uses audio tones to indicate acknowledgment of collected readings, MobileLink's visual user interface utilizes an OLED display to display collected readings.
(5) MedApps HealthCOM software application: The HealthCOM software application allows caregivers access to review patient data collected from accessory medical devices using MedApps hardware on the secure HealthCOM website. HealthCOM software allows professional caregivers to set patient readings. 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 or Medical Record (EHR or EMR).
(6) MedApps IVR software application: The IVR (Interactive Voice Response) software application provides the ability to contact the patient remotely, by phone (designated in the user profile), and executes an pre-approved ("canned") scripts to deliver preapproved ("canned") reminder messages, educational content and gather survey information. In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider.

AI/ML Overview

The provided text describes the MedApps 2.0 - Remote Patient Monitoring System and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the way you've outlined for clinical performance studies.

This document is a 510(k) Premarket Notification summary, which typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new clinical performance studies to establish efficacy against a set of predetermined acceptance criteria.

The key statement is found in section "G. SAFETY AND EFFICACY":
"The MedApps 2.0 Remote Patient Monitoring System 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 does not introduce any new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices."

Therefore, I cannot populate most of the requested fields because the information is not present in the provided document.

Here's what can be extracted based on the document:

Acceptance Criteria and Device Performance Study Details

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The submission relies on substantial equivalence to predicate devices and conformity to recognized consensus standards, rather than specific clinical performance acceptance criteria.	Not applicable. The document explicitly states, "The MedApps 2.0 Remote Patient Monitoring System does not rely on an assessment of clinical performance data."

2. Sample size used for the test set and data provenance:
Not applicable. No clinical test set or patient data for performance evaluation is described. The relevant testing is "design control verification and validation testing" and "certification testing."

3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. No clinical test set with ground truth established by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set with adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
No. The document explicitly states that the device does not rely on clinical performance data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a "Remote Patient Monitoring System," which involves collecting and transmitting patient data from accessory devices to healthcare professionals. Its performance is related to accurate data transmission and system functionality, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical performance. For system validation, the "ground truth" would be the expected functional behavior and data integrity as per design specifications and accessory medical device readings.

8. The sample size for the training set:
Not applicable. The document does not describe a machine learning model or "training set" in the context of clinical performance.

9. How the ground truth for the training set was established:
Not applicable.

Summary of Device Verification & Validation (Non-Clinical):

The document mentions the following non-clinical testing:

MedApps' design control verification and validation testing: This included testing all executable code and functionality, and confirming that identified risks were addressed by software functionality, the user interface, documentation, or user SOP.
MedApps Product Verification and Release Plan execution: Ensured both HealthPAL and MobileLink medical devices work with each type of user accessory medical device (glucose, blood pressure monitor, scale, pulse oximeter, and PT/INR) as part of the MedApps 2.0 System, including integration to the HealthCOM backend software application.
Certification testing: EMC (60601-1-2) and Safety (60601-1) as described in MedApps' Declaration of Conformity.

These activities confirm that the system meets its requirements and design specifications but do not constitute a clinical performance study with defined acceptance criteria for diagnostic or prognostic accuracy.

Summary

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PREMARKET NOTIFICATION 510(k) SUMMARY As required by 21 CFR §807.92(c)

Submitter

JUL 3 0 2013

510(k) Owner:	MedApps, Inc., DBA Alere Connect
Owner / Operator:	10027842
Registration:	3005916763
Address:	8767 E. Via De Ventura, Suite 300, Scottsdale, AZ 85258
Telephone:	480-305-6323
Fax Number:	480-305-6328
Contact Person:	Kent Dicks
Contact Person Title:	CEO
Date Prepared:	December 12, 2012

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)

A. LEGALLY MARKETED PREDICATE DEVICE

Legally marketed predicate devices are:
K080798	Intel Health Guide PHS6000
K040966	Carematix Modified System
K083862	MedApps 2.0 - Remote Patient Monitoring System

INDICATIONS FOR USE B.

MedApps Inc., DBA Alere Connect Remote Patient Monitoring devices receive and store measurements collected from the described accessory devices, either wirelessly using short-range radio protocols (e.g. Bluetooth, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USB, serial, etc). Reqardless of connectivity mode, the MedApps / Alere Connect monitoring devices do not alter the indications for use of the described peripheral accessory health devices.

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MedApps/Alere Connect devices indicate successful or failed data reception and transmission with visual and audio feedback using a combination of any of the following: OLED Display, LED Lights, verbal messages, and/or audio tones/chimes. MedApps/Alere Connect devices store collected data and forward/transmit to server for access in HealthCOM via commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax).

Healthcare professionals, clinicians and other authorized personnel can review the transmitted information within the MedApps HealthCOM system, where they can review collected readings, establish parameters to indicate readings exceptions to set thresholds, or trigger Interactive Voice Response (IVR) messages to the patient remotely to issue information such as reminders (e.g. "We haven't received readings from you today, please take and send your readings") or possibly educational information for conditions such as diabetes, hypertension, CHF, etc. Additionally, HealthCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice.

C. MedApps 2.0 SYSTEM DESCRITPION

The MedApps 2.0 - Remote Patient Monitoring System consists of:

(1) HealthPAL hardware:
The physical component of the 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 module, LED lights to indicate activity, timer button to assist patients with their reading schedule (i.e. remind them to take their reading in X minutes), last reading button, volume up and down buttons. The HealthPAL Model 105 contains a GSM cellular module while the HealthPAL Model 106 contains a CDMA cellular module.
(2) HealthHUB hardware / software:
The HealthHUB hardware is an extension of the HealthPAL functionality. HealthHUB acts as a "docking" station for the HealthPAL in order to act as a conduit for the AC power adaptor connecting the electrical wall outlet to the HealthPAL providing power and battery charging capability. The Hubs also provide additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software). The HealthHUB model MA200 allows for multiple wired connections for accessory devices. HealthHUB Model 205 is specific for the HealthPAL MA105, and the HealthHUB 206 is specific for the HealthPAL MA 106 with both Hubs having one wired connector.

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(3) HealthPAL firmware / software:
The firmware captures data from commercially available health monitors, and stores and transmits the information to the HealthCOM server, via the embedded communication chip / platform.

The firmware allows HealthPAL to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the MedApps HealthPAL.

The firmware has many additional functions including:

Download of user profiles from the server to configure HealthPAL . remotelv.
. HealthPAL has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device.
. Timer capability, activated by the user to provide assistance with adhering to a reading schedule (reminders to take readings within a set timeframe).
. OLED screen displays information regarding the HealthPAL's status including battery level, volume level, data transmission status, transmission pending indicator, activity icons / messages and other information to provide ease of use and promote patient adherence; as well as information received from accessory medical devices, such as the type of device, measurement, date and time of the last reading collected.
Battery charging, isolation circuits, and interfaces to individual . accessory medical devices / protocols via the smart cable.
(4) MobileLink (formally HealthAIR) hardware / software:

AC020 MobileLink is a modified MA105 HealthPAL device. The physical component of the MobileLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, OLED screen to review the reading, and LED lights to indicate activity regarding the receiving and transmitting of collected data.

Like the HealthPAL, MobileLink's firmware / software captures, data from commercially available retail health monitors, and stores and transmits information to the HealthCOM server, via the embedded communication chip / platform.

The firmware allows MobileLink to receive information via wire, either standard USB or with a customized USB Smart Cable, from accessory medical devices,

The firmware has many additional functions including:

Download of user profiles from the server to configure MobileLink ● remotely.
. MobileLink's Audio feature uses audio tones to indicate acknowledgment of collected readings from all connected accessory

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medical devices as well as reading transmission via the cellular network.

. MobileLink's visual user interface utilizes an OLED display to display collected readings from attached accessory medical devices as well as reading transmission acknowledgements. MobileLink's visual interface also contains a LED light to show power and provide reading request indication capability.
(୧) MedApps HealthCOM software application:

The HealthCOM software application allows careqivers access to review patient data collected from accessory medical devices using MedApps hardware on the secure HealthCOM website. HealthCOM software allows professional caregivers to set patient readings.

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 or Medical Record (EHR or EMR).

(7T) MedApps IVR software application:
The IVR (Interactive Voice Response) software application provides the ability to contact the patient remotely, by phone (designated in the user profile), and executes an pre-approved ("canned") scripts to deliver preapproved ("canned") 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"), educational content and gather survey information.

In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and other forms of communications in order to contact patients or careqivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider.

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.

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Feature	Intel HealthGuide PHS6000	CarematixModified System	MedAppsSubmission	MedApps 2.0Submission
	K080798	K040966	K083862	K124000
Indications of Use	Enableshealthcareproviders tomonitor andmanage chronicconditions ofpatients remotely	Physiologicalmonitoringsystem thatcollects,accumulates andtransmits patientvital signs andotherphysiological datafrom a patientwho may beremote form the	The MedApps2.0 - RemotePatientMonitoringSystem consistsof apatient device,MedAppsHealthPAL, ......	Same asMedApps withthe exception ofupdates toincludeMobileLinkdevice andPT/INR monitors
Intended Use	TelemedicineSystem	TelemedicineSystem	TelemedicineSystem	Same asPHS6000,Carematix, andMedApps
Intended Users	Home users andHealthcareproviders	Same	Same	Same
Site of Use	Home & Clinic	Same	SameHome(HealthPAL)Clinic(HealthCOM)	SameHome(HealthPAL/MobileLink);Clinic(HealthCOM)
Data CollectionSoftware	Intel CareManagementSuite Software	ProprietarySoftware	MedAppsProprietarySoftware	MedAppsProprietarySoftware
Data CollectionSoftwareFunctionality	Transmit datafrom Sensordevices to Central	Same	Same	Same
Communicationmethod of hubwith CentralServer	Via DSL or PhoneLine Connection	Via modem overtelephone line	Via EmbeddedCellularTechnology	Via EmbeddedCellularTechnology
Types of sensorswhich can beinterfaced (wiredor wirelessly) toreceiver hub	Medical Devicesdesigned forHome:GlucoseScaleBlood PressurePulse OxPeak Flow	Medical Devicesdesigned forHome use:Glucose, ScaleBlood PressurePulse Ox,FEX/PEF,PT/INRTemperature	Medical Devicesdesigned forHome use:Glucose, ScaleBlood PressurePulse Ox	Same asMedApps(Glucose, Scale,BP, Pulse Oxwith PT/INR)
Maximum numberand type ofmeasurementdevices that canbe connected tothe devices	Determined byvital sign devicesthat are designedfor Home use, andhave a data port.(Wireless orWired)	Same	Same	Same

TECHNOLOGICAL CHARACTERISTICS SUMMARY – as required by D. 807.92(a)(6) ﺎ

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Feature	Intel HealthGuide PHS6000	CarematixModified System	MedApps 2.0Submission	MedApps 2.0Submission
	K080798	K040966	K083862	K124000
Maximum datathroughput underworst caseconditions	Multiple readingsare stored on themedical devicesand act as abackup if dataneeds to be re-sent to the server	Same	Same	Same
Time Delay in theprocessing of datacollected andtransmitted	Readings storedin the medicaldevices can besent up to theserver when theconnection isrestored.	Same	Same	Same
Implementationmethod ofcollecting datafrom sensors	Short range radiosystem usingWireless(Bluetooth) andWired (tethered)cables.	Modify OTSsensors withprevious 510kapproval byaddingcommunications	Short rangeradio systemusing Wireless(Bluetooth) andWired (tethered)cables.	Short rangeradio systemusing Wired(tethered)
Sensor Software	Sensor Softwareunchanged	Same	Same	Same
Connectivity	Short range radiosystem usingBluetooth andWired (tethered)cables.	Wired or wirelessto hub	Short rangeradio systemusing Bluetoothand Wired(tethered)cables.	Short rangeradio systemusing Wired(tethered)
Communicationmethod of hubwith devices	Short range radiosystem usingBluetooth andWired (tethered)cables.	Wireless RFprotocol	Short rangeradio systemusing Wireless(Bluetooth) andWired (tethered)cables.	Short rangeradio systemusing Wired(tethered)
CommunicationsProtocol	Bluetooth V2.0andWired (Tethered)	Proprietary	Wireless(Bluetooth) V2.0and Wired(Tethered)	Wired (Tethered)
CommunicationFrequency	Bluetooth : 2.402to 2.480 GHz	915 MHz FCCassigned channel	Bluetooth :2,402 to 2,480GHz(HealthPAL)GSM: 850 / 900/ 1800 / 1950Mhz	(HealthPAL orMobileLink)GSM: 850 / 900/ 1800 / 1950Mhz
Power Source	Wall power plug(120 VAC/50-60)	Wall power plug(120 VAC/50-60)and Batteries inDevice	Wall power plug(120 VAC/50-60)or RechargeableBattery(HealthPAL)	Wall power plug(120 VAC/50-60)or RechargeableBattery(HealthPAL orMobileLink)
Display	On devices andhub, and monitorsconnected tocentral server	Same	Same	Same

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Communicationwith Patients	On screen display	Same	On screendisplay ofReadings, VoiceOutput andInteractive Voice	On screendisplay withaudio tonesinstead of voice.
Use of Thresholds/ Algorithms fordetermining howThresholds are setand changed	Thresholds are setby Healthcareprofessionals inServer Software	Same	Same	Same
Informationpresented to theuser, if it isdifferent fromthat presented bythe measurementdevices	On screen display	Same	Audio/visualreadingfeedback onscreen and byspeaker; andInteractive VoiceResponse (IVR)System forpatient contact	Visual readingfeedback onscreen and audiotone by speaker;and InteractiveVoice Response(IVR) System forpatient contact
Messages andInstructions thatcan be sent to theUser.	On screen display	Same	On screendisplay ofReadings, VoiceOutput andInteractive VoiceResponse (IVR)	On screendisplay ofReadings, VoiceOutput andInteractive VoiceResponse (IVR)

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Below is a Technological Characteristics Summary Comparison between the MA105 HealthPAL and the AC020 MobileLink medical devices:

Feature	MA105 HealthPAL	AC020 MobileLink
Indications of Use	Enables healthcare providers tomonitor and manage biometircpatient data collected remotely	Same
Intended Use	Telemedicine System	Same
Intended Users	Home users and patients outsideof the clinical setting, as well asHealthcare providers forHealthCOM	Same
Site of Use	Remote setting (e.g. Home /Work), Clinic	Same
Data CollectionSoftware & firmware	MedApps Proprietary Software	Same
Data CollectionSoftware Functionality	Transmit data from Sensordevices to Central Database	Same
Communication methodof device hub withCentral Server	Via Embedded CellularTechnology (GSM or CDMA)	Same
Types of sensors whichcan be interfaced (wiredor wirelessly) toreceiver hub	Medical Devices designed forHome use:Glucose, Scale, Blood PressurePulse Ox (adding PT/INR with thissubmission)	Same
Transmission	Transmits information to theMedApps secure host servercalled "HealthCOM"	Same
Implementation methodof collecting data fromsensors and generalConnectivity	Short range radio system usingWireless (Bluetooth) and Wired /tethered (Smart Cables).	MobileLink uses wired /tethered connection (USB,Smart Cables)
Communication methodof hub with devices	Short range radio system usingWireless (Bluetooth) and Wired /tethered (Smart Cables).	MobileLink uses wired /tethered connection (USB,Smart Cables)
CommunicationFrequency	Bluetooth : 2.402 to 2.480 GHzGSM: 850 / 900 / 1800 / 1950Mhz	No Bluetooth capabilityGSM: 850 / 900 / 1800 /1950 Mhz
Power Source	AC adaptor Wall power plug (120VAC/50-60) and RechargeableBatteries in Device	AC Adaptor that is 60601-13rd Edition compatible withLithium battery only used forsoft shut down functionalityand not powering device.
Device Communicationwith Patients	On screen display and audio voicefeedback	On screen display with audiotones instead of voice.
Certification Testing	Safety 60601-1, EMC/EMI/FCC(60601-1-2), ESD & RadiatedImmunity, FCC Bluetooth,(PTCRB), CTIA (battery), ETSI	Safety 60601-1 3rd Edition,EMC/EMI/FCC (60601-1-2),ESD & Radiated Immunity,(PTCRB- in process), ETSI(See Declaration ofConformity)

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Data Collection:

The 2 predicate devices and the MedApps solution connect to medical devices (designed for home use) by either wired (cable) connection or wireless (HealthPAL- Bluetooth). The data is collected from the devices and sent to a secure central server using various communication methods.

Telecommunication Platform to Central Server:

Intel Health uses DSL connectivity (wired point of care), Carematrix uses modem off telephone line; MedApps uses embedded Machine to Machine (M2M) module to transmit data via cellular connectivity.

Patient Feedback Technology:

The 2 predicate devices and the MedApps solution allow data and messages to be displayed on a screen (for the HealthPAL) for the patient to read and acknowledge. MobileLink also uses audio and visual acknowledgement / feedback. The MedApps solution also uses an Interactive Voice Response (IVR) system in order to communicate with the patient and ask questions, gather survey information, or issue reminders.

Backend Data Storage:

All systems (both 2 predicate devices and the MedApps solution), provide a backend system that allows data to be stored, and healthcare professionals to access and monitor collected patient data.

Types of sensors which can be interfaced (wired or wirelessly) to receiver hub:

CareMatix Modified System and the proposed MedApps 2.0 System both include PT/INR monitor as an FDA cleared accessory device to the receiver hub. The CareMatix uses wireless connectivity to the hub whereas the MedApss 2.0 systems uses both wired and wireless connectivity to the hub. CareMatix System 510k (K040966) clearance summary letter includes the predicate Avid Care (K011779 and K010029) telemedicine system that connects to PT/INR monitor as an accessory device.

NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as E. required by 807.92(b)(1)

Non-Clinical Testing

The submitted 2.0 System has undergone MedApps' design control verification and validation testing. MedApps 2.0 validation testing include 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 user SOP.

MedApps 2.0 System verification and validation activities as part of the design control process include testing of all Design Specifications (Design Control Inputs) based on risk analysis, certification standards, and Verification plans. MedApps Product Verification and Release Plan execution on both HealthPAL and MobileLink ensure both medical devices work with each type of user accessory medical device (glucose, blood pressure monitor, scale, pulse oximeter and PT/INR) as part of the MedApps 2.0 System including integration to HealthCOM backend software application. The output of these design control verification analysis documents MedApps 2.0 - Remote Patient Monitoring System shall meet its requirements and design specifications as intended.

Page Exhibit02-9

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Lastly, all relevant certification testing such as EMC (60601-1-2) and Safety (60601-1) are described in MedApps' Declaration of Conformity.

F. · SUBSTANTIAL EQUIVALENT

The MedApps 2.0 Remote Patient Monitoring System 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 integrated to the patient medical device, implementation methods of collecting data from sensors, sensor software. connectivity, communication protocol, power source and general display method.

The MobileLink (formally called HealthAIR communication hub device, described in 510(k) K112559) is substantially equivalent to the HealthPAL (described in 510(k) K083862) as both devices, as part of the MedApps 2.0 System, connect to commercially available Glucose Meters, Scales, Blood Pressure Monitors, Pulse Oximeters, and PT/INR; data is collected, stored and transmitted using off-the-shelf FCC approved wireless / cellular connectivity. Both provide audio and visual feedback / acknowledgement that readings have been collected and transmitted to MedApps' secure host server called "HealthCOM".

SAFETY AND EFFICACY G.

The MedApps 2.0 Remote Patient Monitoring System 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 does not introduce any new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices.

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Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

July 30, 2013

MedApps, Inc. DBA Alere Connect C/O Mr. Kent E. Dicks CEO 8767 E. Via De Ventura, Suite 300 Scottsdale, AZ 85258

Re: K124000

Trade/Device Name: MedApps 2.0 Remote Patient Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: Class II Product Code: DRG Dated: January 18, 2013 Received: July 3, 2013

Dear Mr. Kent E. 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. 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

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Page 2 - Mr. Kent E. Dicks

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/MedicalDeyices/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, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{12}------------------------------------------------

KHIBIT 01

MedApps, Inc., DBA Alere Connect STATEMENT OF INDICATIONS FOR USE

510(k) Number: K124000_

December 12. 2012 Preparation Date:

Device Name: System

MedApps (Alere Connect) 2.0 - Remote Patient Monitoring

Indications For Use:

The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood available PDA Creaters, and PT/INR monitors and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
(Per 21 CFR 801.109)

OR	Over-The-Counter Use	X
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Page Exhibit01-1	Digitally signed by Owen P. Faris -S Date: 2013.07.30 09:07:15 -04'00'
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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).