(97 days)
The MedApps /Alere Connect 2.0 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.
The MedApps 2.0 - Remote Patient Monitoring System consists of:
- HealthPAL hardware: (1) 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.
- HealthHUB hardware / software: (2) 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.
- HealthPAL firmware / software: (3) 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. 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.
- MobileLink hardware / software: (4) 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 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 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.
- HomeLink hardware / software: (5) AC200 HomeLink is a modified MA105 HealthPAL device. The physical component of the HomeLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, touch screen to review the reading and allow patients with ability to have "IVR" (questions and answers) functionality that was formally part of the HealthCOM IVR section, and wireless module. Like the HealthPAL or MobileLink, HomeLink's firmware / software captures biometric data from FDA cleared commercially available accessory devices, and stores and transmits information to the HealthCOM server, via the embedded communication chip / piatform. The firmware allows HomeLink 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 HomeLink device. The firmware has many additional functions including: Download of user profiles from the server to configure HomeLink remotely. HomeLink's has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, volume control, user feedback, in any language that is loaded to the device. HomeLink's visual user interface utilizes a touch screen display to display collected readings from attached accessory medical devices as well as other user interactions. One such patient HomeLink user interface includes the MedApps 2.0 System IVR functionality, which originally was executed from the HealthCOM webportal by professionals to patient's phones. The updated version allows end users (patients) to provide answers on the HomeLink device based on professional predefined questions that are reviewed in HealthCOM. This allows an improved user interaction of the previous IVR procedure. HomeLink screen also displays information regarding the device's status including volume level, data transmission status, preferred language, 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.
- MedApps HealthCOM software application: (6) 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),
- MedApps IVR software application from HealthCOM: (7) 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 pre-approved ("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 caregivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider. The original IVR system has moved to the HomeLink device for easier interaction with the patient compared to the need for the patient to receive an IVR phone call on their personal phone, which includes professionally defined questions that the patient can answer and both the questions and answers will be recorded in the HealthCOM system for professional review.
- Accessory Device Descriptions: (8)
The document describes the MedApps 2.0 - Remote Patient Monitoring System and states that its conformity to FDA's recognized consensus standards demonstrates its safety and efficacy. No specific acceptance criteria or a dedicated study proving device performance against such criteria are explicitly provided. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Compliance with MedApps' design control verification and validation testing for all executable code and functionality, and confirmation that all identified risks have been adequately addressed. | "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." |
| Product Verification and Release Plan execution on HealthPAL, MobileLink, and HomeLink devices to ensure each medical device works with each applicable type of user accessory medical device (glucose, blood pressure monitor, scale, pulse oximeter and PT/INR (excluding HomeLink) as part of the MedApps 2.0 System including integration to HealthCOM backend software application. | "MedApps Product Verification and Release Plan execution on HealthPAL. MobileLink, and HomeLink devices ensures each medical device works with each applicable type of user accessory medical device (glucose, blood pressure monitor, scale, pulse oximeter and PT/INR (excluding HomeLink) as part of the MedApps 2.0 System including integration to HealthCOM backend software application." |
| Verification of the HomeLink question and answer functionality. | "Additionally, the HomeLink question and answer functionality, which moved to the device instead of the patient's personal phone as part of the MedApps 2.0 System was included in the verification testing to ensure this user interface is verified." |
| Compliance with relevant certification testing such as EMC (60601-1-2) and Safety (60601-1). | "Lastly, all relevant certification testing such as EMC (60601-1-2) and Safety (60601-1) are described in MedApps' Declaration of Conformity." |
| System shall meet its requirements and design specifications as intended (based on the output of design control verification analysis). | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical performance evaluation. The testing described is primarily non-clinical performance data testing and review, focused on design control verification and validation. The data provenance is internal to MedApps' development process, likely involving various test environments and scenarios, rather than patient data from a specific country or collected retrospectively/prospectively from a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described appears to be engineering and software verification/validation, not a study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not provided as the described testing is not an adjudication process involving multiple reviewers for clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The MedApps 2.0 Remote Patient Monitoring System does not rely on an assessment of clinical performance data."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a "Remote Patient Monitoring System" that facilitates the collection and transmission of data from accessory medical devices for review by healthcare professionals. While the system operates without direct human intervention during data collection and transmission, its overall function is designed to support human monitoring. The described testing is primarily about the reliability and functionality of data collection and transmission, not a standalone diagnostic or interpretive algorithm's performance in a clinical sense. Therefore, a standalone study evaluating an "algorithm only" performance in the typical sense (e.g., diagnostic accuracy of an AI model) does not appear to have been done or is not relevant to the described device's function as a data transmission hub.
7. Type of Ground Truth Used
For the non-clinical performance testing described, the "ground truth" would be the expected functional behavior and compliance with design specifications and regulatory standards. This is established through the device's design requirements, engineering specifications, and validated test procedures, rather than expert consensus on clinical cases, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable/not provided. The MedApps 2.0 System is a hardware and software system for data collection and transmission, not a machine learning or AI algorithm that requires a "training set" in the conventional sense for clinical interpretation or prediction.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as #8.
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EXHIBIT 02
PREMARKET NOTIFICATION 510(k) SUMMARY As required by 21 CFR §807.92(c)
Submitter
DEC 12 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: | September 3, 2013 |
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 devices are:
| K040966 | Carematix Modified System |
|---|---|
| K083862 | MedApps 2.0 - Remote Patient Monitoring System |
| K124000 | MedApps 2.0 - Remote Patient Monitoring System (with MobileLink added) |
3. INDICATIONS FOR USE
The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL, Alere™ MobileLink or Alere™ HomeLink) 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 (excluding HomeLink) and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.
MedApps / 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
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EXHIBIT 02
K132803 pg 2 of 12
following: 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 /Alere Connect 2.0 Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide realtime / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
C. MedApps 2.0 SYSTEM DESCRITPION
The MedApps 2.0 - Remote Patient Monitoring System consists of:
-
HealthPAL hardware: (1)
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. -
HealthHUB hardware / software: (2)
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.
{2}------------------------------------------------
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. �
- . 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 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 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 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.
- (日) HomeLink hardware / software:
AC200 HomeLink is a modified MA105 HealthPAL device. The physical component of the HomeLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, touch screen to review the reading and allow patients with ability to have "IVR"
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EXHIBIT 02
K132803 pg 4 of 12
(questions and answers) functionality that was formally part of the HealthCOM IVR section, and wireless module.
Like the HealthPAL or MobileLink, HomeLink's firmware / software captures biometric data from FDA cleared commercially available accessory devices, and stores and transmits information to the HealthCOM server, via the embedded communication chip / piatform.
The firmware allows HomeLink 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 HomeLink device.
The firmware has many additional functions including:
- Download of user profiles from the server to configure HomeLink remotely. .
- . HomeLink's has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, volume control, user feedback, in any language that is loaded to the device.
- . HomeLink's visual user interface utilizes a touch screen display to display collected readings from attached accessory medical devices as well as other user interactions. One such patient HomeLink user interface includes the MedApps 2.0 System IVR functionality, which originally was executed from the HealthCOM webportal by professionals to patient's phones. The updated version allows end users (patients) to provide answers on the HomeLink device based on professional predefined questions that are reviewed in HealthCOM. This allows an improved user interaction of the previous IVR procedure. HomeLink screen also displays information regarding the device's status including volume level, data transmission status, preferred language, 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.
- (6) 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),
- (7) MedApps IVR software application from HealthCOM:
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 pre-approved ("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.
{4}------------------------------------------------
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.
The original IVR system has moved to the HomeLink device for easier interaction with the patient compared to the need for the patient to receive an IVR phone call on their personal phone, which includes professionally defined questions that the patient can answer and both the questions and answers will be recorded in the HealthCOM system for professional review.
| OEMAccessoryDevice | Description | Integrated OEM FDA cleared accessory devices | FDAClearancenumber | ||
|---|---|---|---|---|---|
| Manufacturer | Model | Alere Connect Hub Device | |||
| BloodPressureMonitor | Off the shelf device thatmeasures blood pressure,pulse of an individual | A&D Medical | UA-767PBT | HealthPAL &HomeLink | K012472 |
| A&D Medical | UA-767PC | MobileLink | |||
| Scale | Off the shelf device thatmeasures weight of anindividual | A&D Medical | UC-321PBT | HealthPAL &HomeLink | Class 1 no510knumber |
| A&D Medical | UC-321PL | MobileLink | |||
| GlucoseMeters | Off the shelf devices thatmeasure glucose level ofblood for an individual. | LifeScan (J&J)OneTouch | Ultra andUltra2 | HealthPAL,MobileLink &HomeLink | K053529 |
| Abbott | Freestyle Lite | HomeLink | K070850 | ||
| Abbott | FreestyleFreedom Lite | K051839 | |||
| Bayer | Contour | K091820 | |||
| Nipro | TrueBalance | K090495 | |||
| Nipro | TrueResult | K080641 | |||
| PulseOximeter | Prescription Use Devicethat measures oxygenconcentration of anindividual | Nonin | 9560 | HealthPAL &HomeLink | K081285 |
| Oxypulse | OxiPro-6 | MobileLink | K100815 | ||
| PT/INR | Prescription Use Devicethat measuresprothrombin time ofwhole blood formonitoring of oralanticoagulation therapy. | Alere (formallyHemosense) | InRatio2 | HealthPAL &MobileLink | K021923 |
- Accessory Device Descriptions: (8)
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EXHIBIT 02
| K132803 pg 6 of 12 | ||||
|---|---|---|---|---|
| -------------------- | -- | -- | -- | -- |
| Feature | CarematixModified SystemK040966 | MedAppsSubmissionK083862 | MedApps 2.0SubmissionK124000 | MedApps 2.0Submission (Thissubmission) |
|---|---|---|---|---|
| Indications ofUse | Physiologicalmonitoring systemthat collects,accumulates andtransmits patientvital signs and otherdata from a patientwho may be remoteform the healthcarepractitioner to thepractitioner. | The MedApps 2.0 -Remote PatientMonitoring Systemconsists of a patientdevice, MedAppsHealthPAL andHealthCOM softwaremonitoringapplication. | Same as MedApps2.0 with theexception ofupdates to IncludeMobileLink deviceand PT/INR monitoras an accessorydevice | Same as MedApps2.0 System with theaddition of theHomeLink device(similar toHealthPAL andMobileLink Hubdevices) |
| Intended Use | TelemedicineSystem | Telemedicine System | Same as Carematixand MedApps 2.0 | Same as Carematixand MedApps 2.0 |
| Intended Users | Home users andHealthcare providers | Same | Same | Same |
| Site of Use | Home & Clinic | Same | Same | Same |
| Home (HealthPAL)Clinic (HealthCOM) | Home (HealthPAL/MobileLink);Clinic (HealthCOM) | Home (HealthPAL/MobileLink/HomeLink);Clinic (HealthCOM) | ||
| Data CollectionSoftware | Proprietary Software | MedApps ProprietarySoftware | MedAppsProprietarySoftware | MedAppsProprietarySoftware |
| Data CollectionSoftwareFunctionality | Transmit data fromSensor devices toCentral Database | Same | Same | Same |
| Communicationmethod of hubwith CentralServer | Via modem overtelephone line | Via EmbeddedCellular Technology | Via EmbeddedCellular Technology | Via EmbeddedCellular Technology |
| Types ofsensors whichcan beInterfaced(wired orwirelessly) toreceiver hub | Medical Devicesdesigned for Homeuse:Glucose, ScaleBlood PressurePulse Ox,FEX/PEF,PT/INRTemperature | Medical Devicesdesigned for Homeuse:Glucose, ScaleBlood PressurePulse Ox | Same as MedApps(Glucose, Scale, BP,Pulse Ox withPT/INR)Same as CareMatix(PT/INR) | Same as MedApps(Glucose, Scale, BP,Pulse Ox withPT/INR)HomeLink does notinterface withPT/INR |
| Maximumnumber andtype ofmeasurementdevices that canbe connected tothe devices | Determined by vitalsign devices thatare designed forHome use, and havea data port.(Wireless or Wired) | Same | Same | Same |
| Maximum datathroughputunder worstcase conditions | Multiple readingsare stored on themedical devices andact as a backup ifdata needs to be re-sent to the server | Same | Same | Same |
| Feature | CarematixModified System | MedApps 2.0Submission | MedApps 2.0Submission | MedApps 2.0Submission |
| K040966 | K083862 | K124000 | (This Submission) | |
| Time Delay inthe processingof data collectedand transmitted | Readings stored inthe medical devicescan be sent up tothe server when theconnection isrestored. | Same | Same | Same |
| Implementationmethod ofcollecting datafrom sensors | Modify OTS sensorswith previous 510kapproval by addingcommunicationsinterface withoutaltering sensors | Short range radiosystem usingWireless (Bluetooth)and Wired (tethered)cables. | Short range radiosystem using Wired(tethered) | Short range radiosystem usingWireless (Bluetooth)and Wired(tethered) cables. |
| Sensor Software | Sensor Softwareunchanged | Same | Same | Same |
| Connectivity | Wired or wireless tohub | Short range radiosystem usingBluetooth and Wired(tethered) cables. | Short range radiosystem using Wired(tethered) | Short range radiosystem usingBluetooth and Wired(tethered) cables. |
| Communicationmethod of hubwith devices | Wireless RF protocol | Short range radiosystem usingWireless (Bluetooth)and Wired (tethered)cables. | Short range radiosystem using Wired(tethered) | Short range radiosystem usingWireless (Bluetooth)and Wired(tethered) cables. |
| Communications Protocol | Proprietary | Wireless (Bluetooth)V2.0 and Wired(Tethered) | Wired (Tethered) | Wireless (Bluetooth)V2.0 and Wired(Tethered) |
| CommunicationFrequency | 915 MHz FCCassigned channel | (HealthPAL)Bluetooth : 2.402 to2.480GHz GSM: 850 / 900/ 1800 / 1950 Mhz | (HealthPAL orMobileLink)GSM: 850 / 900 /1800 / 1950 Mhz | (HomeLink)Bluetooth : 2.402to 2.480GHz GSM: 850 /900 / 1800 / 1950Mhz |
| Power Source | Wall power plug(120 VAC/50-60)and Batteries inDevice | Wall power plug(120 VAC/50-60) orRechargeable Battery(HealthPAL) | Wall power plug(120 VAC/50-60) orRechargeableBattery (HealthPALor MobileLink) | Wall power plug(120 VAC/50-60)(HomeLink) |
| Display | On devices and hub,and monitorsconnected to centralserver | Same | Same | Same |
| Communicationwith Patients | On screen display | On screen display ofReadings, VoiceOutput andInteractive VoiceResponse (IVR) | On screen displaywith audio tonesinstead of voice. | On screen display ofReadings, VoiceOutput andInteractive VoiceResponse (IVR)through HomeLink |
| Use ofThresholds /Algorithms fordetermininghow Thresholdsare set andchanged | Thresholds are setby Healthcareprofessionals inServer Software | Same | Same | Same |
| Informationpresented to theuser, if it isdifferent fromthat presentedby themeasurementdevices | On screen display | Audio/visual readingfeedback on screenand by speaker; andInteractive VoiceResponse (IVR)System for patientcontact | Visual readingfeedback on screenand audio tone byspeaker; andInteractive VoiceResponse (IVR)System for patientcontact | Audio/visual readingfeedback on screenand by speaker; andInteractive VoiceResponse (IVR)System for patientcontact is throughHomeLink device |
| Messages andInstructionsthat can be sentto the User. | On screen display | On screen display ofReadings, VoiceOutput andInteractive VoiceResponse (IVR) | On screen display ofReadings, VoiceOutput andInteractive VoiceResponse (IVR) | On screen display ofReadings, VoiceOutput andInteractive VoiceResponse (IVR)functionality usesHomeLink device |
TECHNOLOGICAL CHARACTERISTICS SUMMARY – as required by 807.92(a)(6) D.
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EXHIBIT 02
K132803 pg 7 of 12
: .
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EXHIBIT 02
K132803 pg 8 of 12
Below is a Technological Characteristics Summary Comparison between MA105 HealthPAL, AC020 MobileLink, and AC200 HomeLink MedApps 2.0 System devices:
| Feature | MA105 HealthPAL | AC020 MobileLink | AC200 HomeLink |
|---|---|---|---|
| Indications of Use | Enables healthcare providers tomonitor and manage blometircpatient data collected remotely | Same | Same |
| Intended Use | Telemedicine System | Same | Same |
| Intended Users | Home users and patients outsideof the clinical setting, as well asHealthcare providers forHealthCOM | Same | Same |
| Site of Use | Remote setting (e.g. Home /Work), Clinic | Same | Same |
| Data CollectionSoftware (firmware) | MedApps Proprietary Software | Same | Same |
| Data CollectionSoftware Functionality | Transmit data from Sensor devicesto Central Database | Same | Same |
| Communication methodof device hub withCentral Server | Via Embedded Cellular Technology(GSM or CDMA) | Same | Same |
| Types of sensors whichcan be interfaced (wiredor wirelessly) toreceiver hub | Medical Devices designed forHome use:Glucose, Scale, Blood Pressure,Pulse Ox, PT/INR | Medical Devicesdesigned for Homeuse:Glucose, Scale,Blood Pressure,Pulse Ox, PT/INR | Medical Devicesdesigned for Homeuse:Glucose, Scale, BloodPressure, Pulse Ox |
| Transmission | Transmits information to theMedApps secure host server called"HealthCOM" | Same | Same |
| Implementation methodof collecting data fromsensors and generalConnectivity | Short range radio system usingWireless (Bluetooth) and Wired /tethered (Smart Cables). | MobileLink useswired / tetheredconnection (USB,Smart Cables) | Short range radiosystem usingWireless (Bluetooth)and Wired / tethered(Smart Cables). |
| Communication methodof hub with devices | Short range radio system usingWireless (Bluetooth) and Wired /tethered (Smart Cables). | MobileLink useswired / tetheredconnection (USB,Smart Cables) | Short range radiosystem usingWireless (Bluetooth)and Wired / tethered(Smart Cables). |
.
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EXHIBIT 02
K132803 pg 9 of 12
| CommunicationFrequency | Bluetooth : 2.402 to 2.480 GHzGSM: 850 / 900 / 1800 / 1900Mhz | No BluetoothcapabilityGSM: 850 / 900 /1800 / 1900 Mhz | Bluetooth : 2.402 to2.480 GHzGSM: 850 / 900 /1800 / 1900 Mhz |
|---|---|---|---|
| Power Source | AC adaptor Wall power plug (120VAC/50-60) and RechargeableBatteries in Device | AC Adaptor that is60601-1 3rd Editioncompatible withLithium battery onlyused for soft shutdown functionalityand not poweringdevice. | AC Adaptor that is60601-1 3rd Editioncompatible forpowering device. |
| Device Communicationwith Patients | On screen display and audio volcefeedback | On screen displaywith audio tonesinstead of voice. | Touch screen displaywith audio voicefeedback. |
| Applicable CertificationTesting | Safety 60601-1, EMC/EMI/FCC(60601-1-2), ESD & RadiatedImmunity, FCC Bluetooth,(PTCRB), CTIA (battery), ETSI | Safety 60601-1 3rdEdition,EMC/EMI/FCC(60601-1-2), ESD &Radiated Immunity,PTCRB, ETSI(Declaration ofConformity) | Safety 60601-1 3rdEdition,EMC/EMI/FCC(60601-1-2), ESD &Radiated Immunity,PTCRB ETSI (SeeDeclaration ofConformity) |
Technological Characteristics Summary Comparison between MA105 HealthPAL, AC020 MobileLink, and AC200 HomeLink devices as part of the MedApps 2.0 System focusing on the HomeLink modification to other two devices:
| Feature | MA105 HealthPAL | AC020 MobileLink | AC200 HomeLink | ModificationDescription |
|---|---|---|---|---|
| DeviceDimensions | 4.2"x 2.1" x 0.9",weighs 3 oz. | 4.5" x 1.9" x 0.75",weighs 2.8 oz. | 5.1" x 7.9" x 0.7",welghs 17 oz. | Modified to increase thesize of the device |
| UserInterface | 1.8" Full ColorPassive Matrix OLEDand buttons | 1.54" single colorOLED and buttons | 7" Full Color TouchScreen | Modified to a touchscreen instead ofbuttons |
| VoiceInterface | Voice and tones | Tones only | Voice and tones | Same as HealthPAL |
| Microprocessors | C8051F344 (SiliconLabs); 8051architecture | PIC32MX975F512L(Microchip); MIPSarchitecture | PIC32MX975F512L(Microchip); MIPSarchitecture | Same as MobileLink |
| MemoryDevices | 4GB MicroSD Card;SDHC | 4GB or 8GB MicroSDCard; SDHC | 4GB or 8GB MicroSD;SDHC | Same as MobileLink |
| EnergySources | Main PowerSupply:SHWA12A-S022(MEPOS)6061-13" Ed.[external]Switching PowerSupplies:TPS61080, BQ24014,TPS63001(TI);LTC3525(Linear)[internal] | Main PowerSupply: 18ur-09-2000(Group West)Power Supplycomponents:BQ24014 (TI),TPS61080(TI);LTC3122(Liner);A4490 (Allegro)[Internal] | Main PowerSupply: 18ur-09-2000(Group West)Power Supplycomponents:BQ24014(TI);LTC2427,LT1617,LT1930(Linear);XC9119(Torex);A4490(Allegro)[internal | Power Supply same asMobileLink;More Internal powersupply componentscompared to other twodevices |
| SafetyFeatures | ESD Protection:TPD6E001 (TI) | ESD Protection:TPD6E001 (TI) | ESD Protection:TPD6E001 (TI) | Same as both devices |
| Communications to Server | Cell Module:GSM0308-10(Enfora); | Cell Module:SL8081 (SierraWireless); | Celi Module:SL8081 (SierraWireless); . | Same as MobileLink |
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EXHIBIT 02 K132803 pg 10 of 12
| Communications toAccessoryDevices | Bluetooth:WT11-A-Ai4(BlueGiga);SerialCommunicationthough Smart Cable(30 pin) | SerialCommunicationthrough SmartCable (USB) | Bluetooth: WT11-A-Al4(BlueGiga); BR-LE4.0-S2A(BlueRadios); FitLinxx;Serial Communicationthrough Smart Cable(USB) | Bluetooth same asHealthPAL;Added Bluetooth lowenergy and Fitlinxx |
|---|---|---|---|---|
| Programming Language | C ProgrammingLanguage | C ProgrammingLanguage | C ProgrammingLanguage | Same as HealthPAL andMobileLink |
| FirmwareArchitecture | Single threaded | Multi-threaded(RTOS) | Multi-threaded (RTOS) | Same as MobileLink |
| IVRfunctionalitycommunicațion | Professional useHealthCOM; EndUsers use their phone | Professional useHealthCOM: EndUsers use theirphone | Professional useHealthCOM; End Usersuse HomeLink | HomeLink is used forIVR functionalityinstead of the EndUser's phone |
Data Collection:
The one predicate device and the MedApps 2.0 System solution connect to medical devices (designed for home use) by either wired (cable) connection or wireless (HealthPAL/HomeLink- Bluetooth). The data is collected from the devices and sent to a secure central server using various communication methods.
Telecommunication Platform to Central Server:
Carematrix uses modem off telephone line; MedApps 2.0 System devices uses embedded Machine to Machine (M2M) module to transmit data via cellular connectivity.
Patient Feedback Technology:
The predicate device and the MedApps solution allow data and messages to be displayed on a screen (for the HealthPAL/HomeLink) for the patient to read and acknowledge. MobileLink also uses audio and visual acknowledgement / feedback. The MedApps 2.0 System 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. The HomeLink includes the user interface (IVR process) as part of the user interaction instead of using a patient's phone.
Backend Data Storage:
All systems (predicate device and the MedApps 2.0 system 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 MedApps 2.0 System 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. The HomeLink includes all of the original MedApps 2.0 System (K083862) accessory devices without interfacing with the PT/INR monitor at this time.
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NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by E. 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 HealthPAL. MobileLink, and HomeLink devices ensures each medical device works with each applicable type of user accessory medical device (glucose, blood pressure monitor, scale, pulse oximeter and PT/INR (excluding HomeLink) 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. Additionally, the HomeLink question and answer functionality, which moved to the device instead of the patient's personal phone as part of the MedApps 2.0 System was included in the verification testing to ensure this user interface is verified.
Lastly, all relevant certification testing such as EMC (60601-1-2) and Safety (60601-1) are described in MedApps' Declaration of Conformity.
SUBSTANTIAL EQUIVALENT F.
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 HomeLink (this submission) is substantially equivalent to the HealthPAL (described in 510(k) K083862) and MobileLink (K124000) as all three 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. All devices provide audio and visual feedback / acknowledgement that readings have been collected and transmitted to MedApps' secure host server called "HealthCOM". The HomeLink (this submission) 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; data is collected, stored and transmitted using off-the-shelf FCC approved wireless / cellular connectivity. Both provide audio (voice) and visual feedback / acknowledgement that readings have been collected and transmitted to MedApps' secure host server called "HealthCOM". Both devices also use wireless connectivity (Bluetooth) for accessory devices that have this capability.
G. SAFETY AND EFFICACY ·
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EXHIBIT 02
K132803 pg 12 of 12
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/12/Picture/1 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 features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2013
Medapps Inc., Dba Alere Connect Kent Dicks 8767 E. Via De Ventura, Ste 300 Scottsdale, AZ 85258 US
Re: K132803
Trade/Device Name: Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link Regulation Number: 21 CFR 870.2910 Regulation Name: Medapps Remote Patient Monitoring System Regulatory Class: Class II Product Code: DRG, NBW Dated: 11/12/2013 Received: 11/11/2013
Dear Kent 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.
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Page 2 - Kent Dicks
. . – •ı ••••
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 (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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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
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EXHIBIT 01
MedApps, Inc., DBA Alere Connect STATEMENT OF INDICATIONS FOR USE
K132803 510(k) Number: _
Preparation Date: September 3, 2013
Device Name: System
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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, Alere™ MobileLink or Alere™ HomeLink) 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 (excluding Homel.ink) and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system.
MedApps / 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: 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 /Alere Connect 2.0 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.
(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 | ||
| Page Exhibit01-1 | |||
| Digitally signed by Owen P. Faris -S Date: 2013.12.12 14:51:39 -05'00' |
§ 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).