(97 days)
Not Found
No
The document describes a system for collecting, storing, and transmitting patient data from accessory devices. It mentions data management, setting thresholds for exceptions, and triggering pre-approved messages (IVR). There is no mention of the system learning from data, making predictions, or using algorithms typically associated with AI/ML for analysis or decision-making beyond simple threshold comparisons.
No
The device is a remote patient monitoring system used to collect and transmit data from other medical devices, but it explicitly states that it "is not intended for diagnosis or as a substitute for medical care" and is not intended to "provide real-time / time-critical data." It does not directly provide therapeutic treatment.
No
The "Intended Use / Indications for Use" section explicitly states: "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." Instead, it collects and transmits data from other FDA-cleared accessory devices for review by healthcare professionals.
No
The device description explicitly details multiple hardware components, including the HealthPAL, HealthHUB, MobileLink, and HomeLink devices, which are physical electronic devices with enclosures, screens, cellular chips, speakers, and various ports and connections. While software/firmware is mentioned as part of these components, the system is not solely software.
Based on the provided text, the MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the system "is not intended for diagnosis or as a substitute for medical care". IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details hardware and software components that collect and transmit data from other medical devices (glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors). It does not describe any components or processes for analyzing biological specimens.
- Functionality: The system's primary function is to receive, store, and transmit data from accessory devices to healthcare professionals. It also provides communication features (IVR, messages) for patient reminders and education. This is consistent with remote patient monitoring, not in vitro diagnostics.
- Lack of Specimen Handling: There is no mention of the device handling or analyzing any biological specimens.
In summary, the MedApps 2.0 system acts as a data collection and communication hub for other medical devices that may or may not be IVDs themselves (e.g., a glucose meter is an IVD, but a scale is not). The system itself does not perform any in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, NBW
Device Description
The MedApps 2.0 - Remote Patient Monitoring System consists of:
- 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.
- 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.
- 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, time settings, volume control, educational content and reminders in any loaded language; timer capability; OLED screen displays information regarding HealthPAL's status, activity icons/messages, and information from accessory medical devices; battery charging, isolation circuits, and interfaces to individual accessory medical devices via smart cable.
- 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; audio tones to indicate acknowledgment of collected readings from all connected accessory medical devices as well as reading transmission via the cellular network; OLED display to display collected readings and transmission acknowledgements; LED light to show power and provide reading request indication capability.
- 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" (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 / platform. 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; audio capability to deliver verbal announcement of readings and acknowledgment of data transmission, volume control, user feedback in any loaded language; touch screen display to display collected readings and other user interactions, including MedApps 2.0 System IVR functionality; screen also displays information regarding the device's status including volume level, data transmission status, preferred language, transmission pending indicator, activity icons/messages, and information received from accessory medical devices.
- 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).
- 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 pre-approved ("canned") scripts to deliver pre-approved ("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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home users and patients outside of the clinical setting, as well as Healthcare providers for HealthCOM.
Site of Use: Remote setting (e.g. Home / Work), Clinic.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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"
3
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.
| OEM
Accessory
Device | Description | Integrated OEM FDA cleared accessory devices | | | FDA
Clearance
number |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------|----------------------------------------|------------------------------|
| | | Manufacturer | Model | Alere Connect Hub Device | |
| Blood
Pressure
Monitor | Off the shelf device that
measures 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 that
measures weight of an
individual | A&D Medical | UC-321PBT | HealthPAL &
HomeLink | Class 1 no
510k
number |
| | | A&D Medical | UC-321PL | MobileLink | |
| Glucose
Meters | Off the shelf devices that
measure glucose level of
blood for an individual. | LifeScan (J&J)
OneTouch | Ultra and
Ultra2 | HealthPAL,
MobileLink &
HomeLink | K053529 |
| | | Abbott | Freestyle Lite | HomeLink | K070850 |
| | | Abbott | Freestyle
Freedom Lite | | K051839 |
| | | Bayer | Contour | | K091820 |
| | | Nipro | TrueBalance | | K090495 |
| | | Nipro | TrueResult | | K080641 |
| Pulse
Oximeter | Prescription Use Device
that measures oxygen
concentration of an
individual | Nonin | 9560 | HealthPAL &
HomeLink | K081285 |
| | | Oxypulse | OxiPro-6 | MobileLink | K100815 |
| PT/INR | Prescription Use Device
that measures
prothrombin time of
whole blood for
monitoring of oral
anticoagulation therapy. | Alere (formally
Hemosense) | InRatio2 | HealthPAL &
MobileLink | K021923 |
- Accessory Device Descriptions: (8)
5
EXHIBIT 02
| K132803 pg 6 of 12 | ||||
|---|---|---|---|---|
| -------------------- | -- | -- | -- | -- |
| Feature | Carematix
Modified System
K040966 | MedApps
Submission
K083862 | MedApps 2.0
Submission
K124000 | MedApps 2.0
Submission (This
submission) |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications of
Use | Physiological
monitoring system
that collects,
accumulates and
transmits patient
vital signs and other
data from a patient
who may be remote
form the healthcare
practitioner to the
practitioner. | The MedApps 2.0 -
Remote Patient
Monitoring System
consists of a patient
device, MedApps
HealthPAL and
HealthCOM software
monitoring
application. | Same as MedApps
2.0 with the
exception of
updates to Include
MobileLink device
and PT/INR monitor
as an accessory
device | Same as MedApps
2.0 System with the
addition of the
HomeLink device
(similar to
HealthPAL and
MobileLink Hub
devices) |
| Intended Use | Telemedicine
System | Telemedicine System | Same as Carematix
and MedApps 2.0 | Same as Carematix
and MedApps 2.0 |
| Intended Users | Home users and
Healthcare 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 Collection
Software | Proprietary Software | MedApps Proprietary
Software | MedApps
Proprietary
Software | MedApps
Proprietary
Software |
| Data Collection
Software
Functionality | Transmit data from
Sensor devices to
Central Database | Same | Same | Same |
| Communication
method of hub
with Central
Server | Via modem over
telephone line | Via Embedded
Cellular Technology | Via Embedded
Cellular Technology | Via Embedded
Cellular Technology |
| Types of
sensors which
can be
Interfaced
(wired or
wirelessly) to
receiver hub | Medical Devices
designed for Home
use:
Glucose, Scale
Blood Pressure
Pulse Ox,
FEX/PEF,PT/INR
Temperature | Medical Devices
designed for Home
use:
Glucose, Scale
Blood Pressure
Pulse Ox | Same as MedApps
(Glucose, Scale, BP,
Pulse Ox with
PT/INR)
Same as CareMatix
(PT/INR) | Same as MedApps
(Glucose, Scale, BP,
Pulse Ox with
PT/INR)
HomeLink does not
interface with
PT/INR |
| Maximum
number and
type of
measurement
devices that can
be connected to
the devices | Determined by vital
sign devices that
are designed for
Home use, and have
a data port.
(Wireless or Wired) | Same | Same | Same |
| Maximum data
throughput
under worst
case conditions | Multiple readings
are stored on the
medical devices and
act as a backup if
data needs to be re-
sent to the server | Same | Same | Same |
| Feature | Carematix
Modified System | MedApps 2.0
Submission | MedApps 2.0
Submission | MedApps 2.0
Submission |
| | K040966 | K083862 | K124000 | (This Submission) |
| Time Delay in
the processing
of data collected
and transmitted | Readings stored in
the medical devices
can be sent up to
the server when the
connection is
restored. | Same | Same | Same |
| Implementation
method of
collecting data
from sensors | Modify OTS sensors
with previous 510k
approval by adding
communications
interface without
altering sensors | Short range radio
system using
Wireless (Bluetooth)
and Wired (tethered)
cables. | Short range radio
system using Wired
(tethered) | Short range radio
system using
Wireless (Bluetooth)
and Wired
(tethered) cables. |
| Sensor Software | Sensor Software
unchanged | Same | Same | Same |
| Connectivity | Wired or wireless to
hub | Short range radio
system using
Bluetooth and Wired
(tethered) cables. | Short range radio
system using Wired
(tethered) | Short range radio
system using
Bluetooth and Wired
(tethered) cables. |
| Communication
method of hub
with devices | Wireless RF protocol | Short range radio
system using
Wireless (Bluetooth)
and Wired (tethered)
cables. | Short range radio
system using Wired
(tethered) | Short range radio
system using
Wireless (Bluetooth)
and Wired
(tethered) cables. |
| Communication
s Protocol | Proprietary | Wireless (Bluetooth)
V2.0 and Wired
(Tethered) | Wired (Tethered) | Wireless (Bluetooth)
V2.0 and Wired
(Tethered) |
| Communication
Frequency | 915 MHz FCC
assigned channel | (HealthPAL)
Bluetooth : 2.402 to
2.480
GHz GSM: 850 / 900
/ 1800 / 1950 Mhz | (HealthPAL or
MobileLink)
GSM: 850 / 900 /
1800 / 1950 Mhz | (HomeLink)
Bluetooth : 2.402
to 2.480
GHz GSM: 850 /
900 / 1800 / 1950
Mhz |
| Power Source | Wall power plug
(120 VAC/50-60)
and Batteries in
Device | Wall power plug
(120 VAC/50-60) or
Rechargeable Battery
(HealthPAL) | Wall power plug
(120 VAC/50-60) or
Rechargeable
Battery (HealthPAL
or MobileLink) | Wall power plug
(120 VAC/50-60)
(HomeLink) |
| Display | On devices and hub,
and monitors
connected to central
server | Same | Same | Same |
| Communication
with Patients | On screen display | On screen display of
Readings, Voice
Output and
Interactive Voice
Response (IVR) | On screen display
with audio tones
instead of voice. | On screen display of
Readings, Voice
Output and
Interactive Voice
Response (IVR)
through HomeLink |
| Use of
Thresholds /
Algorithms for
determining
how Thresholds
are set and
changed | Thresholds are set
by Healthcare
professionals in
Server Software | Same | Same | Same |
| Information
presented to the
user, if it is
different from
that presented
by the
measurement
devices | On screen display | Audio/visual reading
feedback on screen
and by speaker; and
Interactive Voice
Response (IVR)
System for patient
contact | Visual reading
feedback on screen
and audio tone by
speaker; and
Interactive Voice
Response (IVR)
System for patient
contact | Audio/visual reading
feedback on screen
and by speaker; and
Interactive Voice
Response (IVR)
System for patient
contact is through
HomeLink device |
| Messages and
Instructions
that can be sent
to the User. | On screen display | On screen display of
Readings, Voice
Output and
Interactive Voice
Response (IVR) | On screen display of
Readings, Voice
Output and
Interactive Voice
Response (IVR) | On screen display of
Readings, Voice
Output and
Interactive Voice
Response (IVR)
functionality uses
HomeLink device |
TECHNOLOGICAL CHARACTERISTICS SUMMARY – as required by 807.92(a)(6) D.
6
EXHIBIT 02
K132803 pg 7 of 12
: .
7
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 to | ||
| monitor and manage blometirc | |||
| patient data collected remotely | Same | Same | |
| Intended Use | Telemedicine System | Same | Same |
| Intended Users | Home users and patients outside | ||
| of the clinical setting, as well as | |||
| Healthcare providers for | |||
| HealthCOM | Same | Same | |
| Site of Use | Remote setting (e.g. Home / | ||
| Work), Clinic | Same | Same | |
| Data Collection | |||
| Software (firmware) | MedApps Proprietary Software | Same | Same |
| Data Collection | |||
| Software Functionality | Transmit data from Sensor devices | ||
| to Central Database | Same | Same | |
| Communication method | |||
| of device hub with | |||
| Central Server | Via Embedded Cellular Technology | ||
| (GSM or CDMA) | Same | Same | |
| Types of sensors which | |||
| can be interfaced (wired | |||
| or wirelessly) to | |||
| receiver hub | Medical Devices designed for | ||
| Home use: | |||
| Glucose, Scale, Blood Pressure, | |||
| Pulse Ox, PT/INR | Medical Devices | ||
| designed for Home | |||
| use: | |||
| Glucose, Scale, | |||
| Blood Pressure, | |||
| Pulse Ox, PT/INR | Medical Devices | ||
| designed for Home | |||
| use: | |||
| Glucose, Scale, Blood | |||
| Pressure, Pulse Ox | |||
| Transmission | Transmits information to the | ||
| MedApps secure host server called | |||
| "HealthCOM" | Same | Same | |
| Implementation method | |||
| of collecting data from | |||
| sensors and general | |||
| Connectivity | Short range radio system using | ||
| Wireless (Bluetooth) and Wired / | |||
| tethered (Smart Cables). | MobileLink uses | ||
| wired / tethered | |||
| connection (USB, | |||
| Smart Cables) | Short range radio | ||
| system using | |||
| Wireless (Bluetooth) | |||
| and Wired / tethered | |||
| (Smart Cables). | |||
| Communication method | |||
| of hub with devices | Short range radio system using | ||
| Wireless (Bluetooth) and Wired / | |||
| tethered (Smart Cables). | MobileLink uses | ||
| wired / tethered | |||
| connection (USB, | |||
| Smart Cables) | Short range radio | ||
| system using | |||
| Wireless (Bluetooth) | |||
| and Wired / tethered | |||
| (Smart Cables). |
.
8
EXHIBIT 02
K132803 pg 9 of 12
| Communication
Frequency | Bluetooth : 2.402 to 2.480 GHz
GSM: 850 / 900 / 1800 / 1900
Mhz | No Bluetooth
capability
GSM: 850 / 900 /
1800 / 1900 Mhz | Bluetooth : 2.402 to
2.480 GHz
GSM: 850 / 900 /
1800 / 1900 Mhz |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC adaptor Wall power plug (120
VAC/50-60) and Rechargeable
Batteries in Device | AC Adaptor that is
60601-1 3rd Edition
compatible with
Lithium battery only
used for soft shut
down functionality
and not powering
device. | AC Adaptor that is
60601-1 3rd Edition
compatible for
powering device. |
| Device Communication
with Patients | On screen display and audio volce
feedback | On screen display
with audio tones
instead of voice. | Touch screen display
with audio voice
feedback. |
| Applicable Certification
Testing | Safety 60601-1, EMC/EMI/FCC
(60601-1-2), ESD & Radiated
Immunity, FCC Bluetooth,
(PTCRB), CTIA (battery), ETSI | Safety 60601-1 3rd
Edition,
EMC/EMI/FCC
(60601-1-2), ESD &
Radiated Immunity,
PTCRB, ETSI
(Declaration of
Conformity) | Safety 60601-1 3rd
Edition,
EMC/EMI/FCC
(60601-1-2), ESD &
Radiated Immunity,
PTCRB ETSI (See
Declaration of
Conformity) |
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 | Modification
Description |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device
Dimensions | 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 the
size of the device |
| User
Interface | 1.8" Full Color
Passive Matrix OLED
and buttons | 1.54" single color
OLED and buttons | 7" Full Color Touch
Screen | Modified to a touch
screen instead of
buttons |
| Voice
Interface | Voice and tones | Tones only | Voice and tones | Same as HealthPAL |
| Microprocess
ors | C8051F344 (Silicon
Labs); 8051
architecture | PIC32MX975F512L
(Microchip); MIPS
architecture | PIC32MX975F512L
(Microchip); MIPS
architecture | Same as MobileLink |
| Memory
Devices | 4GB MicroSD Card;
SDHC | 4GB or 8GB MicroSD
Card; SDHC | 4GB or 8GB MicroSD;
SDHC | Same as MobileLink |
| Energy
Sources | Main Power
Supply:SHWA12A-
S022(MEPOS)6061-1
3" Ed.[external]
Switching Power
Supplies:
TPS61080, BQ24014,
TPS63001(TI);
LTC3525(Linear)[inte
rnal] | Main Power
Supply: 18ur-09-
2000(Group West)
Power Supply
components:
BQ24014 (TI),
TPS61080(TI);
LTC3122(Liner);
A4490 (Allegro)
[Internal] | Main Power
Supply: 18ur-09-2000
(Group West)
Power Supply
components:
BQ24014(TI);
LTC2427,LT1617,
LT1930(Linear);
XC9119(Torex);
A4490(Allegro)[internal | Power Supply same as
MobileLink;
More Internal power
supply components
compared to other two
devices |
| Safety
Features | ESD Protection:
TPD6E001 (TI) | ESD Protection:
TPD6E001 (TI) | ESD Protection:
TPD6E001 (TI) | Same as both devices |
| Communicati
ons to Server | Cell Module:
GSM0308-
10(Enfora); | Cell Module:
SL8081 (Sierra
Wireless); | Celi Module:
SL8081 (Sierra
Wireless); . | Same as MobileLink |
9
EXHIBIT 02 K132803 pg 10 of 12
| Communicati
ons to
Accessory
Devices | Bluetooth:
WT11-A-
Ai4(BlueGiga);
Serial
Communication
though Smart Cable
(30 pin) | Serial
Communication
through Smart
Cable (USB) | Bluetooth: WT11-A-
Al4(BlueGiga); BR-
LE4.0-S2A(Blue
Radios); FitLinxx;
Serial Communication
through Smart Cable
(USB) | Bluetooth same as
HealthPAL;
Added Bluetooth low
energy and Fitlinxx |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Programmin
g Language | C Programming
Language | C Programming
Language | C Programming
Language | Same as HealthPAL and
MobileLink |
| Firmware
Architecture | Single threaded | Multi-threaded
(RTOS) | Multi-threaded (RTOS) | Same as MobileLink |
| IVR
functionality
communicați
on | Professional use
HealthCOM; End
Users use their phone | Professional use
HealthCOM: End
Users use their
phone | Professional use
HealthCOM; End Users
use HomeLink | HomeLink is used for
IVR functionality
instead of the End
User'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.
10
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 ·
11
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.
12
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.
13
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
14
EXHIBIT 01
MedApps, Inc., DBA Alere Connect STATEMENT OF INDICATIONS FOR USE
K132803 510(k) Number: _
Preparation Date: September 3, 2013
Device Name: System
・ー (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2) -- (2
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' |