(322 days)
No
The document describes a system for collecting and transmitting historical patient data based on "business rules set by the healthcare providers," which is a deterministic process, not AI/ML. There is no mention of AI, ML, or related concepts.
No
Explanation: The Intended Use section explicitly states that the system "is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment." It acts as an accessory to collect and transmit data, not to provide therapy itself.
No
The device collects and transmits historical data from other FDA-cleared medical devices (like glucometers) for review by healthcare professionals, but it explicitly states it is "not intended to provide automated treatment decisions" or be "a substitute for a professional healthcare judgment," and that "All patient medical diagnosis and treatment are performed under the supervision and oversight of an appropriate healthcare professional." This indicates it is for data management and display, not for making diagnoses.
Yes
The device description explicitly states that the system is comprised of "Hub" (cell phone software) and the "MedApps Engine" (software on a central server). While it interacts with hardware (glucometer, cell phone), the device itself, as described, is the software component that collects, transmits, and processes the data.
Based on the provided text, the MedApps Wellness System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for collecting and transmitting historical data from FDA cleared devices (specifically a blood glucose monitor and a remote module) to healthcare professionals. It is explicitly stated that the system is not intended to provide automated treatment decisions or be a substitute for professional healthcare judgment.
- Device Description: The device description details a system that collects data from a medical device (glucometer), transmits it via a cell phone to a server, and then stores it for review by healthcare providers. It also mentions an optional IVR call to collect behavioral information.
- Lack of Diagnostic Function: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The MedApps Wellness System does not perform any such analysis of biological specimens. It simply acts as a data collection and transmission tool for data generated by another device (the blood glucose monitor).
- Accessory to IVD: The text states the MedApps Wellness System acts as an accessory to FDA cleared devices, including the LifeScan OneTouch Ultra Blood Glucose Monitoring System. Blood glucose monitors are IVD devices because they analyze a blood sample to measure glucose levels. The MedApps system is facilitating the communication of the data from the IVD, not performing the diagnostic test itself.
In summary, the MedApps Wellness System is a data management and communication system that supports the use of an IVD device (the blood glucose monitor), but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The MedApps Wellness System is intended for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of patients.
The System is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are performed under the supervision and oversight of an appropriate healthcare professional.
The MedApps Wellness System model D-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner.
The following medical devices and measuring systems are fully validated for this intended use at this time:
- . LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System (K024194 / K043197)
- . Polytel PWR-08-03 Remote Module (K070559 pending clearance)
The MedApps Wellness System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The MedApps Wellness System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.
Product codes
DRG, NBW
Device Description
The MedApps Wellness System ("System") is designed to be used by patients to send their data from the LifeScan OneTouch Ultra glucometer to a central server for subsequent storage and display.
The System is comprised of a "Hub" (cell phone software) and the MedApps Engine, which runs on a central server.
The Hub is a software program that runs on a cell phone and takes in data from the OneTouch Ultra and then transmits it to the central server for storage and processing.
The MedApps Engine is a software program that runs on a common Web / Internet secure server platform. The MedApps Engine picks up the stored data sent to it by the Hub and through a set of business rules set by the healthcare providers, determines if a follow-up Interactive Voice Response (IVR) call is required to be made to the patient to collect additional Behavioral information from the patient.
Once all the data is collected, then it is stored in a repository for access by the healthcare provider,
The Hub will utilize the OneTouch Ultra integrated Short-range low power wireless transmission (Bluetooth V1.2) or a FDA approved accessory to the medical devices that to transmits the medical device data via Bluetooth to a compatible cellular telephone, such as the Nokia 6620, or other /compatible cellular phones.
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, 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 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 Software Design Specifications (SDS), 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 Wellness 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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92
Device Name - as required by 807.92(a)(2):
| 510(k) Number: | K062377 |
|---|---|
| Trade Name: | MedApps™ Remote Patient Monitoring System |
| Common/Classification Name: | Transmitters and Receivers, Physiological Signal, |
| Radiofrequency | |
| Classification Regulation: | 870.2910 |
| Device Class: | Class II |
| Product Code (Procode): | DRG |
| Premarket Notification submitter: | |
| Company Name: | |
| Company Address: | MedApps, Inc. |
| 7975 North Hayden Road, | |
| Suite B-200, Scottsdale, AZ 85258 | |
| Contact: | Kent E. Dicks, President and CEO |
| Preparation Date: | |
| Revision Date: | August 14, 2006 |
| April 3, 2007 |
A. LEGALLY MARKETED PREDICATE DEVICE – as required by 807.92(a)(3)
Legally marketed predicate device are: K061328 Think Positive (t+) Diabetes Management System The Hermes System K050929
The submitted device is intended to be an accessory device to the OneTouch® Ultra® Blood Glucose Monitoring System LifeScan (K024194/K043197).
DEVICE DESCRIPTION - as required by 807.92(a)(4) B.
The MedApps Wellness System ("System") is designed to be used by patients to send their data from the LifeScan OneTouch Ultra glucometer to a central server for subsequent storage and display.
The System is comprised of a "Hub" (cell phone software) and the MedApps Engine, which runs on a central server.
The Hub is a software program that runs on a cell phone and takes in data from the OneTouch Ultra and then transmits it to the central server for storage and processing.
1
The MedApps Engine is a software program that runs on a common Web / Internet secure server platform. The MedApps Engine picks up the stored data sent to it by the Hub and through a set of business rules set by the healthcare providers, determines if a follow-up Interactive Voice Response (IVR) call is required to be made to the patient to collect additional Behavioral information from the patient.
Once all the data is collected, then it is stored in a repository for access by the healthcare provider,
The Hub will utilize the OneTouch Ultra integrated Short-range low power wireless transmission (Bluetooth V1.2) or a FDA approved accessory to the medical devices that to transmits the medical device data via Bluetooth to a compatible cellular telephone, such as the Nokia 6620, or other /compatible cellular phones.
C. INTENDED USE - as required by 807.92(a)(5)
The MedApps Wellness System is intended for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of patients.
The System is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are performed under the supervision and oversight of an appropriate healthcare professional.
D. INDICATIONS FOR USE
The MedApps Wellness System model D-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner.
The following medical devices and measuring systems are fully validated for this intended use at this time:
- . LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System (K024194 / K043197)
- . Polytel PWR-08-03 Remote Module (K070559 pending clearance)
The MedApps Wellness System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The MedApps Wellness System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.
2
MedApps, Inc. 510(k) SUMMARY
Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.
This device is not for use in systems which substitute for medical care.
This device is not intended for patients requiring direct medical supervision or emergency intervention.
E. LEVEL OF CONCERN - as requested by recent FDA guidance
The FDA guidance document "Guidance For The Content of Premarket Submissions For Software Contained In Medical Devices," May 11, 2005, clearly identifies that all manufacturers of software devices are responsible for determining a Level of Concern for their device(s).
MedApps, Inc. believes that this device, because of its functional characteristics and intended uses, has a MODERATE LEVEL OF CONCERN. See Exhibit 4, Level of Concern.
TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by F. 807.92(a)(6)
| Feature | Think Positive
K061328 | The Hermes
K050929 | MedApps
(Submission
Device) |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------|
| 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, Clinic | Same | Same |
| Data Collection
Software | Think Positive
Proprietary
Software | The Hermes
Proprietary
Software | MedApps
Proprietary
Software |
| Data Collection
Software
Functionality | Transmit data from
Sensor devices to
Central Database | Same | Same |
| Communication
method of hub
with Central
Server | Via Cellular Phone | Same | Same |
| Feature | Think Positive
K061328 | The Hermes
K050929 | MedApps
(Submission
Device) |
| Types of sensors
which can be
interfaced (wired
or wirelessly) to
receiver hub | Glucose Levels | Same | Same |
| Implementation
method of
collecting data
from sensors | Short range radio
system using
Bluetooth and
Cellular technology | Same | Same |
| Sensor Software | Sensor Software
unchanged | Same | Same |
| Connectivity | Short range radio
system using
Bluetooth and
Cellular technology | Same | Same |
| Communication
method of hub
with devices | Short range radio
system using
Bluetooth and
Cellular technology | Same | Same |
| Communications
Protocol | Bluetooth V1.2 | Same | Same |
| Communication
Frequency | 2.402 to 2.480
GHz | Same | Same |
| Power Source | Wall power plug for
hub (120 VAC/50-
60) and batteries
in devices | Same | Same |
| 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 and
Interactive Voice
Response (IVR) |
000005
3
:
MedApps, Inc.
510(k) SUMMARY
.
:
:
4
NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as G. 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 Software Design Specifications (SDS), 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 Wellness System met its required requirements and design specifications as intended.
H. SUBSTANTIAL EQUIVALENCE SUMMARY
The submitted device, MedApps Wellness System, has the same indications for use as the predicate devices, Think Positive (t+) Diabetes Management System and The Hermes System.
I. CONCLUSIONS
The performance and usability testing and validation studies document that MedApps Wellness System is substantially equivalent to the predicate Think Positive (t+) Diabetes Management System and The Hermes System.
000007
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MedApps, Inc. c/o Mr. Kent E. Dicks President/CEO 7975 North Hayden Road, Suite B-200 Scottsdale, AZ 85258
JUL - 3 2007
Re: K062377
Trade/Device Name: MedApps™ Remote Patient Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 26, 2007 Received: June 27, 2007
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(a) marketed predicate device results in a classification for your device on thus, server to your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please onte the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloh inc (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number (if known): K062377
Device Name: MedApps™ Remote Patient Monitoring System
Indication For Use:
The MedApps Remote Patient Monitoring System model d-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner.
The following medical devices and measuring systems are fully validated for this intended use at this time:
- · LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System (K024194/K043197)
- · Polytel PWR-08-03 Remote Module (K070559)
The MedApps Remote Patient Monitoring System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The MedApps Remote Patient Monitoring System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or timecritical data. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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