(158 days)
Not Found
No
The description focuses on data collection, transmission, storage, display, and basic threshold-based flagging and pre-programmed messaging. There is no mention of algorithms that learn or adapt from data, which are characteristic of AI/ML.
No.
The "Intended Use / Indications for Use" explicitly states, "The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care..." This indicates it's a monitoring and communication system, not a device that provides therapy or direct medical treatment.
No
The document explicitly states, "The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care."
No
The device description explicitly details multiple hardware components, including the MedApps HealthPAL hardware, HealthLINK hardware, and HealthPOD hardware, in addition to the software applications.
Based on the provided text, the MedApps 2.0 - Remote Patient Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Function of MedApps 2.0: The MedApps 2.0 system acts as a communication hub and data management system. It collects data from other commercially available medical devices (Glucose Meters, Scales, Blood Pressure Monitors, Pulse Oximeters) and transmits it to healthcare professionals. It does not perform any analysis or testing on biological specimens itself.
- Intended Use Statement: The intended use explicitly states that the system is "not intended for diagnosis or as a substitute for medical care". While it facilitates the review of data that could be used for diagnosis or monitoring by a healthcare professional, the device itself is not performing the diagnostic test.
- Device Description: The description focuses on the hardware and software components that handle data collection, storage, transmission, and communication. It does not mention any components or processes related to analyzing biological samples.
In summary, the MedApps 2.0 system is a remote patient monitoring system that facilitates the flow of data from other medical devices. It does not perform the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. . The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Product codes
DRG
Device Description
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System consists of:
(1) MedApps HealthPAL hardware:
The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless, LED Lights to indicate activity, timer button to remind the patient to take their reading in X minutes, last reading button, volume up and down buttons.
- (2) MedApps HealthPAL software application:
The software application captures, stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform.
The software application takes in additional information via the embedded wireless module from other medical devices that are wireless enabled, and that have been paired to the MedApps HealthPAL.
The software application has many additional functions including:
-
Download of the users profile from the server to configure the . HealthPAL remotely. .
-
Ability to "talk" to the patient with verbal acknowledgments of . readings from all attached medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device.
-
Timer set that was activated by the user at a set timeframe to ● do whatever they wanted to be reminded to do.
-
Control the OLED screen to show certain information including, . battery status, volume level, transmission status, message waiting indicator, medical device last reading, activity icons / messages and more as it pertains to provide ease of use and easier adoption for the patient.
-
Battery charging, isolation circuits, and interfaces to individual . medical devices / protocols via the smart cables.
-
(3) MedApps HealthLINK hardware / software:
The HealthLINK hardware / software plugs into off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, and transmit the data via wireless to a receiver that it is already paired with. This functionality was cleared in the MedApps D-PAL submission K062377 in July 2007.
-
(4) MedApps HealthPOD hardware / software:
The HealthPOD hardware / software is an extension of the HealthPAL functionality that is outlined in this submission. HealthPOD acts as a "docking" station for the HealthPAL in order to recharge batteries, take in additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software), add a backup communication method via phone line (POTS line), and communicate via wireless to HealthPAL or additional HealthPODs. -
(5) MedApps HealthCOM software application:
The software application allows caregivers to set thresholds and review patient data on the secure HealthCOM website.
The HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record (EHR or EMR).
- (6) MedApps IVR software application:
The software application calls the patient on any phone that is designated in their user profile, and executes an approved ("canned") script to gather information. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and many other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on parameters / thresholds set in the HealthCOM system.
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 Healthcare providers (Home (HealthPAL), Clinic (HealthCOM))
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 device has undergone significant verification and validation testing, Alpha validation testing included testing of all executable code and functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface, documentation or user SOP.
Alpha validation activities included exhaustive validation scripts of all Detail Design Specifications (DDS), which was summarized and discussed to provide a preliminary record of performance data. Additionally, the submitter duplicated the operational environment of a sophisticated user and provided the complete record of those executed scripts as operational performance data. The output of these two performance data records documents that MedApps 2.0 - Remote Patient Monitoring System met its required requirements and design specifications as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MedApps, Inc. 510(k) SUMMARY
. K083862
P.1/7
PREMARKET NOTIFICATION 510(k) SUMMARY
As required by 21 CFR §807.92(c)
Submitter
510(k) Owner: MedApps, Inc. Owner / Operator: 10027842 Registration : 3005916763 7975 North Hayden Road, Suite A-200, Scottsdale, AZ 85258 Address: Telephone: 480-305-6323 480-393-1892 Fax Number: Contact Person: Kent Dicks Contact Person Title: President / CEO December 23, 2008 Date Prepared:
Device Information
| Trade Name: | MedApps 2.0 - Remote Patient Monitoring System |
|---|---|
| Common Name: | Remote Patient Monitoring System |
| Classification Status: | Class II per regulations 870.2910 |
| Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency (21 CFR 870.2910. Product Code DRG) |
LEGALLY MARKETED PREDICATE DEVICE A.
Legally marketed predicate device are: Intel Health Guide PHS6000 K080798 K072698 Confidant 2.5 MedApps Remote Patient Monitoring System (D-PAL) K062377
B. DEVICE DESCRIPTION
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
1
K083862 p. 2/7
The HealthCOM system allows the patient to login and create a personal account. The patient can specify / authorize which Personal Health Record (PHR) or Electronic Health Record (EHR / EMR) they would like to send / view their data within, outside of the HealthCOM system.
The MedApps 2.0 - Remote Patient Monitoring System uses MedApps Accessories that help the patient in usability of the product, including HealthLINK which docks the HealthPAL, and HealthPOD which connects to off the shelf medical devices via their data port to transmit data via wireless or RF technology (including, but not limited to bluetooth, zigbee, ANT, ULP, etc.).
The MedApps 2.0 - Remote Patient Monitoring System consists of:
(1) MedApps HealthPAL hardware:
The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless, LED Lights to indicate activity, timer button to remind the patient to take their reading in X minutes, last reading button, volume up and down buttons.
- (2) MedApps HealthPAL software application:
The software application captures, stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform.
The software application takes in additional information via the embedded wireless module from other medical devices that are wireless enabled, and that have been paired to the MedApps HealthPAL.
The software application has many additional functions including:
- Download of the users profile from the server to configure the . HealthPAL remotely. .
- Ability to "talk" to the patient with verbal acknowledgments of . readings from all attached medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device.
- Timer set that was activated by the user at a set timeframe to ● do whatever they wanted to be reminded to do.
- Control the OLED screen to show certain information including, . battery status, volume level, transmission status, message waiting indicator, medical device last reading, activity icons / messages and more as it pertains to provide ease of use and easier adoption for the patient.
- Battery charging, isolation circuits, and interfaces to individual . medical devices / protocols via the smart cables.
2
MedApps, Inc. 510(k) SUMMARY
K083862 p.3/7
- . For complete comparison of predicate devices see paragraph D - TECHNOLOGICAL CHARACTERISTICS SUMMARY table below. please reference Exhibit 08 - System Additionally, Requirements Specifications (FDA-SRS-8009) document for complete software / system functionality.
- (3) MedApps HealthLINK hardware / software:
The HealthLINK hardware / software plugs into off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, and transmit the data via wireless to a receiver that it is already paired with. This functionality was cleared in the MedApps D-PAL submission K062377 in July 2007.
-
(4) MedApps HealthPOD hardware / software:
The HealthPOD hardware / software is an extension of the HealthPAL functionality that is outlined in this submission. HealthPOD acts as a "docking" station for the HealthPAL in order to recharge batteries, take in additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software), add a backup communication method via phone line (POTS line), and communicate via wireless to HealthPAL or additional HealthPODs. -
(5) MedApps HealthCOM software application:
The software application allows caregivers to set thresholds and review patient data on the secure HealthCOM website.
The HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record (EHR or EMR).
- (6) MedApps IVR software application:
The software application calls the patient on any phone that is designated in their user profile, and executes an approved ("canned") script to gather information. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and many other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on parameters / thresholds set in the HealthCOM system.
3
K083862 p. 4/7
INDICATIONS FOR USE C.
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
| Feature | Intel Health
Guide PHS6000
K080798 | Confidant 2.5
K072698 | MedApps
Submission
K083862 |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications of
Use | Enables healthcare
providers to
monitor and
manage chronic
conditions of
patients remotely | Same | Same |
| Intended Use | Telemedicine
System | Same | Same |
| Intended Users | Home users and
Healthcare
providers | Same | Same |
| Site of Use | Home (HealthPAL),
Clinic (HealthCOM) | Same | Same |
| Data Collection
Software | Intel Care
Management Suite
Software | The Hermes
Proprietary
Software | MedApps
Proprietary
Software |
| SUMMARY | | | K083862 |
| Feature | Intel Health
Guide PHS6000 | Confidant 2.5 | MedApps
Submission |
| | K080798 | K072698 | K083862 |
| Data Collection
Software
Functionality | Transmit data from
Sensor devices to
Central Database | Same | Same |
| Communication
method of hub
with Central
Server | Via DSL or Phone
Line Connection | Via Cellular Phone | Via Embedded
Cellular
Technology |
| Types of sensors
which can be
interfaced (wired
or wirelessly) to
receiver hub | Medical Devices
designed for
Home:
Glucose
Scale
Blood Pressure
Pulse Ox
Peak Flow | Medical Devices
designed for
Home:
Glucose
Scale
Blood Pressure | Medical Devices
designed for
Home:
Glucose
Scale
Blood Pressure
Pulse Ox |
| Maximum
number and type
of measurement
devices that can
be connected to
the devices | Determined by
vital sign devices
that are designed
for Home use, and
have a data port.
(Wireless or Wired) | Same | Same |
| Maximum data
throughput
under worst case
conditions | Multiple readings
are stored on the
medical devices
and act as a
backup if data
needs to be re-sent
to the server | Same | Same |
| Time Delay in the
processing of
data collected
and transmitted | Readings stored in
the medical
devices can be sent
up to the server
when the
connection is
restored. | Same | Same |
| Implementation
method of
collecting data
from sensors | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. | Short range radio
system using
Bluetooth | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. |
| Sensor Software | Sensor Software
unchanged | Same | Same |
| Connectivity | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. | Short range radio
system using
Bluetooth | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. |
| Communication
method of hub
with devices | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. | Short range radio
system using
Bluetooth | Short range radio
system using
Bluetooth and
Wired (tethered)
cables. |
| SUMMARY | | | |
| Feature | Intel Health
Guide PHS6000
K080798 | Confidant 2.5
K072698 | MedApps
Submission
K083862 |
| Communications
Protocol | Bluetooth V2.0 and
Wired (Tethered) | Bluetooth V2.0 | Bluetooth V2.0 and
Wired (Tethered) |
| Communication
Frequency | Bluetooth : 2.402
to 2.480 GHz | Bluetooth : 2.402
to 2.480 GHz
GSM: 850 / 900 /
1800 / 1950 Mhz | Bluetooth : 2.402
to 2.480 GHz
GSM: 850 / 900 /
1800 / 1950 Mhz |
| Power Source | Wall power plug
(120 VAC/50-60) | Wall power plug
(120 VAC/50-60)
and Rechargeable
Batteries in Device | Wall power plug
(120 VAC/50-60)
and Rechargeable
Batteries in Device |
| Display | On devices and
hub, and monitors
connected to
central server | Same | Same |
| Communication
with Patients | On screen display | Same | On screen display
of Readings, Voice
Output and
Interactive Voice
Response (IVR) |
| Use of
Thresholds /
Algorithms for
determining how
Thresholds are
set and changed | Thresholds are set
by Healthcare
professionals in
Server Software | Same | Same |
| Information
presented to the
user, if it is
different from
that presented
by the
measurement
devices | On screen display | Same | On screen display
of Readings, Voice
Output and
Interactive Voice
Response (IVR) |
| Messages and
Instructions that
can be sent to
the User. | On screen display | Same | On screen display
of Readings, Voice
Output and
Interactive Voice
Response (IVR) |
TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by D. 807.92(a)(6)
4
:
:
、
:
.
:
.
・
、
. . . . . . .
:
EXHIBIT 02
:
5
Data Collection:
The 2 predicates and the MedApps solution connect to medical devices (designed for home use) via either through wired (cable) or wireless (bluetooth). The data is collected from the devices and sent up to the central server via various communication methods.
Telecommunication Platform to Central Server:
Intel Health uses DSL connectivity (wired point of care), Confidant uses an off the shelf Cell Phone (Cellular), and MedApps uses an embedded Machine to Machine (M2M) module that transmits the data via cellular connectivity.
6
EXHIBIT 02
K083862 p.7/7
Patient Feedback Technology:
On the 2 predicates and MedApps, data and messages are displayed on a screen for the patient to read and acknowledge. The MedApps solution also uses an Interactive Voice Response (IVR) system in order to call up the patient and ask them a question, or remind them to take their readings.
Backend Data Storage:
All systems (2 predicates and MedApps), have a backend system that allows data to be stored, and for Healthcare professionals to have the ability to monitor the patients data.
NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as E. required by 807.92(b)(1)
Non-Clinical Testing
The submitted device has undergone significant verification and validation testing, Alpha validation testing included testing of all executable code and functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface, documentation or user SOP.
Alpha validation activities included exhaustive validation scripts of all Detail Design Specifications (DDS), which was summarized and discussed to provide a preliminary record of performance data. Additionally, the submitter duplicated the operational environment of a sophisticated user and provided the complete record of those executed scripts as operational performance data. The output of these two performance data records documents that MedApps 2.0 - Remote Patient Monitoring System met its required requirements and design specifications as intended.
F. SUBSTANTIAL EQUIVALENT
The MedApps Remote Patient Monitoring System 2.0 is substantially equivalent to the predicate devices in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source and display method.
G. SAFETY AND EFFICACY
The MedApps Remote Patient Monitoring System 2.0 does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate its safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ..
JUN ~ 5 2009
MedApps, Inc. c/o Mr. Kent Dicks President & CEO 7975 North Hayden Road, Suite A-200 Scottsdale, AZ 85258
Re: K083862
Trade/Device Name: MedApps 2.0 Remote Patient Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: March 31, 2009 Received: April 1, 2009
Dear Mr. Dicks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
8
Page 2 - Mr. Kent Dicks
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R. Rohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
| MedApps, Inc. |
|---|
| STATEMENT OF INDICATIONS FOR USE |
510(k) Number: _K083862
Preparation Date:
December 23, 2008
Device Name:
MedApps 2.0 - Remote Patient Monitoring System
Indications For Use:
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. . The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
X
Dunia R. James
Division of Cardiovascular Devices
510(k) Number K083862