(208 days)
No
The summary explicitly states that the device "does not measure, interpret or make any decisions on the data that it conveys." This indicates a lack of AI/ML capabilities for data analysis or decision-making.
No
The device is described as "accessory software" that collects, records, and transmits biometric data for monitoring and analysis, it does not directly treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device collects, records, and transmits biometric data for analysis by healthcare professionals and patients for self-management. However, the text explicitly states, "It does not measure, interpret or make any decisions on the data that it conveys," indicating it does not perform diagnostic functions but rather facilitates data transfer.
Yes
The device is described as a "software platform" and "accessory software" that collects, records, and transmits data from external devices. It does not appear to include any hardware components itself.
Based on the provided information, the MyHealthPoint Telehealth Manager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They perform tests on these specimens.
- MyHealthPoint's Function: The MyHealthPoint Telehealth Manager's primary function is to collect, record, and transmit biometric data from external home-monitoring devices. It acts as a data aggregator and communication tool.
- No Specimen Testing: The description explicitly states that the device "does not measure, interpret or make any decisions on the data that it conveys." It doesn't perform any tests on biological specimens. It simply handles data generated by other devices.
- Data Source: The data it collects comes from devices that measure things like blood pressure, weight, glucose (measured by a separate glucose meter), etc., not from direct analysis of a specimen by the MyHealthPoint software itself.
In summary, the MyHealthPoint Telehealth Manager is a software platform for managing and transmitting health data, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Product codes
DRG, JQP, DXN, DQA, FLL, DPS, DRX, NXB, FRI, OUG
Device Description
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The supported cleared, home-monitoring devices currently marketed with the MyHealthPoint TeleHealth Manager for wireless collection of data and physiological information is in the table below and the systems Architecture is explained on page 3.
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
Patients, clinicians, and caregivers in non-clinical settings (e.g. home).
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
The MyHealthPoint TeleHealth Manager is a software application, therefore no electrical safety or electromagnetic testing was required. After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified. Testing conducted to demonstrate software validation and substantial equivalence included:
- Verification testing that product meets product performance and functional specifications.
- Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)
- User performance testing to demonstrate adequate instructional utility of the User Manual.
Key Metrics
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
APR 1 4 2014
Image /page/0/Picture/1 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S" arranged horizontally. The "h" is inside of a black circle. Below the letters is the text "Entra Health Systems".
December 26, 2013
| Entra Health Systems LLC | |
|---|---|
| 3111 Camino del Rio North | |
| Suite 101 | |
| San Diego, CA 92108 | |
| Main 877 458 2646 | |
| Fax 619 584 4504 | |
| K132930 |
(in accordance with 21 CFR 807.92)
| A. Submitter: | Entra Health Systems |
|---|---|
| B. Address: | 3111 Camino Del Rio North |
| Suite 101 | |
| San Diego CA 92108 | |
| C. Corporate Contact: | Richard Strobridge, CEO |
| Entra Health Systems | |
| D. Telephone: | Ph: 877-458-2646 |
| Fax: 619-584-4504 | |
| E. Submission Contact: | Emily Davis, Project Manager |
| Entra Health Systems | |
| 3111 Camino Del Rio North | |
| Suite 101 | |
| San Diego CA 92108 | |
| Ph: 877-458-2646 | |
| edavis@entrahealthsystems.com | |
| F. Trade Name: | MyHealthPoint TeleHealth Manager |
| G. Predicate Device(s): | - Vignet TeleHealth Manager, K113446 |
-
Honeywell Genesis DM Monitor, K101242
-
Verizon Wireless Converged Health Management Device, K122458 |
| H. Common Name: | Telemedicine System | -
I. Classification:
| Regulation
Number | Product
Code | Classification Name | Device
Class |
|-------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2910 | DRG | Radiofrequency Physiological Signal
Transmitter and Receiver | II |
| Medical device product codes also supported by MyHealthPoint Telehealth Manager by
means of separate medical devices | | | |
| 862.2100 | JQP | Calculator/Data Processing Module | I |
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement | II |
| 870.2700 | DQA | Oximeter | II |
| 880.2910 | FLL | Thermometer, Electronic, Clinical | II |
| 870.2340 | DPS | Elecrocardiograph | II |
| 870.2360 | DRX | Electrocardiograph electrode | II |
| 890.5060 | NXB | Medication Reminder | I |
| 880.2700 | FRI | Patient Weight Scale | I |
| 880.6310 | OUG | Medical device data system | I |
1
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- J. Device Description
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The supported cleared, home-monitoring devices currently marketed with the MyHealthPoint TeleHealth Manager for wireless collection of data and physiological information is in the table below and the systems Architecture is explained on page 3.
| No. | Vital Signs/
Product Code | Measurement | Vital Signs Equipment
Manufacturers/Models (510k) | Connection Type to
MyHealthPoint |
|-----|------------------------------|-------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------|
| 1 | Glucose | Blood glucose (mg/dl or
mmol/L) | Entra Health Systems,
MGH-BT1, K081703 | Bluetooth through
Mobile App, USB or
MDDS Device |
| 2 | Weight | Weight Scale ((lbs. or
Kgs.)/Body Composition | AnD, UC-321PBT | Bluetooth through
MDDS Device |
| | | | Omron, HBF-206IT | Bluetooth through
MDDS Device |
| | | | Fora Weight Scale, W310b | Bluetooth through
MDDS Device |
| | | | Withings Wi-Fi Scale, WS-50 | Wifi through Home
Router |
| 3 | Pulse
Oximetry | Pulse Rate and Oxygen
Saturation | Nonin, 95608T (K09336) | Bluetooth through
MDDS Device |
| 4 | Blood
Pressure | Blood pressure (Systolic
(mmHg), Diastolic (mmHg)) | AnD,UA-767BTB (K043217) | Bluetooth through
MDDS Device |
| | | | Omron BP Monitor, BP792IT
(K131742) | Bluetooth through
MDDS Device |
| | | | Fora BP Monitor, P20b (K092106) | Bluetooth through
MDDS Device |
| 5 | Pedometer | Steps, Calories, Sleep | Fitbit, Flexx, Zip, One, Force | Bluetooth through
MDDS Device and
USB |
| | | | BodyMedia, Link, Core | Bluetooth through
MDDS Device and
USB |
| 6 | ECG | Heart Rate, Respiration | Zephyr , Bioharness 3.1 9607.0090
(K113045) | Bluetooth through
MDDS Device |
| 7 | Thermometer | Body Temperature (Celsius or
Fahrenheit) | For a, IR20b (K090395) | Bluetooth through
MDDS Device |
2
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| 8 | Transfer of
Data | Medical Device Data System | Qualcomm 2Net,
65-KA123 | Receives Bluetooth
and sends Cellular |
|---|------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------|
| 9 | Medication
Reminder | Member has the optional ability
to add medications or products
they are using with a reminder
sent by SMS or email. | Entra Health Systems | Software
component only. |
MyHealthPoint TeleHealth System Architecture
Image /page/2/Figure/4 description: The image shows a diagram of a health monitoring system. The system includes wireless devices such as a weight scale, glucose monitor, and blood pressure monitor. These devices connect to interface devices like smartphones, tablets, and computers, which then transmit data to a central data server called the 'MyHealthPoint Platform'. The platform provides APIs for third-party apps and hospital systems, and the data is displayed on mobile devices and clinician portals.
K. Intended Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly, collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared. MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
- L. Predicate Devices
The MyHealthPoint Management System is substantially equivalent to the following FDA cleared predicate devices:
3
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Predicate #1
510(k) Number: Trade Name: Manufacturer: Classification Name:
Common/Usual Name: Regulation Number: Product Codes: Subsequent Product Codes: Classification:
K113446 Vignet TeleHealth Manager Vignet Inc. Radiofrequency Physiological Signal Transmitter and Receiver Telemedicine System 870.2910 DRG DXN, NBW, FRW Class II
Predicate #2
K101242 510(k) Number: Trade Name: Genesis DM Monitor Manufacturer: Honeywell HomMed, LLC Radiofrequency Physiological Signal Transmitter Classification Name: and Receiver Common/Usual Name: Patient Vital Signs Monitor 870.2910 Regulation Number: Product Codes: DRG Subsequent Product Codes: DXN, DQA, FRI, NBW, BZH, FLL, GJS, DPS, NXB Classification: Class II
Predicate #3
| 510(k) Number: | K122458 |
|---|---|
| Trade Name: | Verizon Wireless Converged Health Management |
| (CHM) Device | |
| Manufacturer: | Verizon Wireless |
| Classification Name: | Radiofrequency Physiological Signal Transmitter |
| and Receiver | |
| Common/Usual Name: | Telemedicine System |
| Regulation Number: | 870.2910 |
| Product Codes: | DRG |
| Subsequent Product Codes: | DXN, NBW, FRW |
| Classification: | Class II |
Entra Health systems has determined that the MyHealthPoint TeleHealth Manager is substantially equivalent to the performance of the three mention predicate devices. The differences between these systems are incidental and not significant. The devices use a similar technological characteristics and principles. Substantial Equivalence section in this submission (Tab 11) explains more on the similarities and equivalence.
4
M. Technological Characteristics
The MyHealthPoint TeleHealth Manager is a software platform for the collection and display of biometric data, from primarily supported patient monitoring devices, to the patient, caregiver and clinician. It is used with in combination with a variety of FDA cleared external bio-metric measuring devices included in the table that follows. Technological characteristics of our device compared to each predicate is shown on the following tables and in the Substantial Equivalence (Tab 11).
M1.DEVICES
| Vital Signs/
Product Code | Measurement of
Submitted Device
(MyHealthPoint) | Vital Signs Equipment
Manufacturers/Models
(510k) | Predicate #1
Vignet Inc. | Predicate #2
Honeywell
HomMed | Predicate #3
Verizon
Wireless |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|------------------------------------------|
| Glucose
(NBW) | Blood glucose
(mg/dl or mmol/L) | Entra Health Systems,
MGH-BT1, K081703
AnD, UC-321PBT | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Weight (FRI) | Weight Scale (lbs.
or Kgs.)/
Body Composition | Omron, HBF-206IT
Fora Weight Scale,
W310b
Withings Wi-Fi Scale,
WS-50 | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Pulse
Oximetry
(DQA) | Pulse Rate and
Oxygen Saturation | Nonin, 9560BT, K09336 | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Blood
Pressure
(DXN) | Blood pressure
((Systolic (mmHg),
Diastolic (mmHg)) | AnD, UA-767PBT,
K043217
Omron BP Monitor,
BP792IT, K131742
Fora BP Monitor, P20b,
K092106 | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Pedometer
(Activity) | Steps, Calories,
Sleep | Fitbit, Flexx, Zip, One,
Force
BodyMedia, Link, Core | Substantially
Equivalent | Does not track
activity. | Does not track
activity. |
| ECG (DSI,DRX,
DPS) | Heart Rate,
Respiration | Zephyr , Bioharness 3.1
9607.0090, K113045 | Does not have
ECG | Substantially
Equivalent | Does not have
ECG |
| Thermometer
(FLL) | Body Temperature
(Celsius or
Fahrenheit) | For a, IR20b, K090395 | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Transfer of
Data (OUG) | Medical Device Data
System | Qualcomm 2Net,
65-KA123 | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Medication
Reminder
(NXB) | Member has the
optional ability to
add medications or
products they are
using with a
reminder sent by | Built into
MyHealthPoint by Entra
Health Systems. | Does not have
medication
reminder. | Substantially
Equivalent | Does not have
medication
reminder. |
5
M2.FEATURES
| Feature | Submitted Device
(My Health Point) | Predicate #1
Vignet Inc. | Predicate #2
Honeywell
HomMed | Predicate #3
Verizon Wireless |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------|----------------------------------|
| Intended Use | Home use, wireless
collection of data;
Remote data access | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Indication for
Use (Ref: Tab 4) | Remote health
management | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| System
description | Software, wireless,
reporting and charts,
messaging, targets and
alerts | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Feature | Submitted Device
(MyHealthPoint) | Predicate #1
Vignet Inc. | Predicate #2
Honeywell
HomMed | Predicate #3
Verizon Wireless |
| Data Collection
software | Proprietary Software | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Types of home
use devices
interfaced | FDA cleared home
devices: Glucose, Blood
pressure, weight/body
composition, pulse
oximeter, thermometer,
ECG, activity, medication
reminder | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Data Capture
method
(connectivity) | Wireless, cellular, server
to server, client to
server. | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Power source | Smart device battery,
plug for MDDS | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Display | Computer, smart phone | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Messaging | Secure messages, SMS
messaging, motivational,
reminders, on line
graphical reports and
charts, personal
progress indicators | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
| Configuration of
personal
wellness regimen | Configures patient alert
settings set by clinician.
Messaging. | Substantially
Equivalent | Substantially
Equivalent | Substantially Equivalent |
N. Performance (non-clinical) data
The MyHealthPoint TeleHealth Manager is a software application, therefore no electrical safety or electromagnetic testing was required. After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis,
6
Image /page/6/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S" arranged horizontally. The "h" is inside a black circle, and the letters are separated by vertical lines. Below the letters, the words "Entra Health Systems" are written in a stylized font.
no new issues of safety, performance, technology or intended use were identified. Testing conducted to demonstrate software validation and substantial equivalence included:
- . Verification testing that product meets product performance and functional specifications.
- . Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)
- User performance testing to demonstrate adequate instructional utility of the User . Manual.
Therefore the MyHealthPoint TeleHealth Manager is concluded to be substantially equivalent to the identified predicates.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Entra Health Systems Richard Strobridge 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 US
Re: K132930
Trade/Device Name: MyHealthPoint TeleHealth Manager Regulation Number: 21 CFR 870.2910 Regulation Name: Telemedicine System Regulatory Class: Class II Product Code: DRG, JQP, DXN, DQA, FLL, DPS, DRX, NXB, FRI, OUG Dated: March 15, 2014 Received: March 21, 2014
Dear Richard Strobridge:
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
8
Page 2 - Richard Strobridge
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 devicerelated 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 free number 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
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Indications for Use
510(k) Number (if known):
Device Name: MyHealthPoint Telehealth Manager
Indications for Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/9/Picture/14 description: The image shows a logo with the letters FDA and the word Date. The date is 2014.04.08:59-04'00'. The logo is in black and white.
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