(153 days)
No
The description focuses on data management, storage, and display (logbook, graphs, trending reports) of blood glucose data. There is no mention of algorithms that learn or make predictions based on the data.
No
The device is a data management system that assists in the review and evaluation of blood glucose test results. It is not intended to provide automated treatment guidance or decisions.
No
The "Intended Use / Indications for Use" section explicitly states, "The System is not indicated for the diagnosis or screening of diabetes." Its purpose is to review and evaluate blood glucose test results to aid in diabetes management.
No
The device description explicitly states it is an "internet browser based data management system for use with the Genesis Health Technologies Blood Glucose Meter". It relies on data transmitted from a physical blood glucose meter and a CDMA module within that meter. While the data management system itself is software, it is intrinsically linked to and dependent on the hardware components of the blood glucose meter for its function.
Based on the provided information, the Genesis Health Record System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is an "accessory to the Genesis Health Technologies Blood Glucose Meter" and is used to "assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management." It explicitly states it is "not intended to provide automated treatment guidance or decisions" and is "not indicated for the diagnosis or screening of diabetes."
- Function: The system's primary function is data management – receiving, storing, and displaying blood glucose test results from a separate IVD device (the blood glucose meter). It provides tools for reviewing and visualizing this data (logbook, graphs, trending reports).
- Role in the Diagnostic Process: The system does not perform any diagnostic testing itself. It relies on the results generated by the blood glucose meter, which is the IVD device in this scenario. The system's role is post-analytical, helping users and healthcare professionals interpret and manage the data already generated by the IVD.
In summary, the Genesis Health Record System is a data management and analysis tool that supports the use of an IVD (the blood glucose meter), but it is not an IVD itself because it does not perform the diagnostic test or provide diagnostic results.
N/A
Intended Use / Indications for Use
The Genesis Health Record System is intended to be used as an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123 to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. The System is not intended to provide automated treatment guidance or decisions. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not indicated for the diagnosis or screening of diabetes.
Product codes
NBW, JQP
Device Description
- The Genesis Health Record System (GHRS) is an internet browser based data management system for use with the Genesis Health Technologies Blood Glucose Meter Cleared under K121224.
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
Adult
Intended User / Care Setting
Home use by the patient, professional use by the healthcare professional
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)
Software verification and validation has been performed and demonstrated safety, repeatability and effectiveness of the GHRS remote database and substantial equivalency to the predicate devices.
Bench Testing:
The following Verification and Validation Tests are included in this submission:
Validation of the logbook functionality, including proper date selection/filtering, proper display of all Reading Types, Accuracy of display data for all reading types and verification of all calculations. Found in GHRS V & V Test Plan 2.21.4 pgs.: 13-17.
Validation of the Test History Chart, including proper date selection/filtering, proper display of all Reading Types, ACCURACY of display data for ALL reading types and verification of calculations. Found in GHRS V & V Test Plan 2.21.4 pgs.: 17-18.
Validation of the logbook functionality for the Target Range Chart, including proper date selection/filtering, proper display of all Reading Types, ACCURACY of display data for ALL reading types, verification of calculations. Found in GHRS V & V Test Plan 2.21.4 pgs.: 19-20.
Validation of accuracy of all mathematical calculations including summary data, and statistics used by the system. Found in GHRS V & V Test Plan 2.21.5 All pages.
Validation of data accuracy from meter to server, including ALL upload scenarios including: automatic, delayed, and multiple for all reading types including before meals, after meals, general and all reading ranges including Low, in range, and High. Found in GHRS V & V Test Plan 2,21,6 All pages.
Verification of the device functionality related to data upload and the flight safe switch mode. Found in GHT BGM V & V Test Plan 1.13.1.
Human Factors Study:
A Human Factors study was performed with 25 test Home Use participants, 25 meters, and 4 Healthcare Professionals all with average computer skills. The study evaluated the entire system setup as well as data download and 100% accuracy of the transmitted data. An analysis of user completed tasks was performed. A user evaluation analysis incorporating a 5 point Likert Scale with measures ranging from Strongly Disagree to Strongly Agree was used. The study was also used to confirm 100% accuracy for data transmission from the meter to the data base and data integrity when analyzed in the intended use environment.
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
§ 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
K123136
.
7 2013 MAR
510(k) Summary
| Submitter
807.92(a)(1) | Nathan Cross CEO
Genesis Health Technologies, Inc.
1640 McCracken Blvd.
Paducah, KY 42001
888-263-0003
ncross@genesishealthcaretechnologies.com | |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kathleen Johnson
Medical Device Approvals, Inc.
PO Box 2042
Fairfield, IA 52556
641-472-0775
kathleen@mdapprovals.com | |
| Date Prepared | December 12, 2012 | |
| Trade Name
807.92(a)(2) | Genesis Health Record System (GHRS) | |
| Common Name | Data Management System | |
| Classification Name
807.92(a)(2) | 21 CFR 862.2100 Calculator/data processing module for clinical use
Class II regulated as an accessory to Blood Glucose Meters | |
| Classification Panel | Clinical Chemistry 71 | |
| Product Code | NBW-System test Blood Glucose Over the Counter
JQP-Calculator/Data Processing Module for Clinical Use | |
| Predicate Device
807.92(a)(3) | ISENS PC care blood Glucose data Management Software
K100937 | |
| Device Description
807.92(a)(4) | 1. The Genesis Health Record System (GHRS) is an internet
browser based data management system for use with the
Genesis Health Technologies Blood Glucose Meter Cleared
under K121224. | |
| Operating Principle | 2. The GHRS data management system allows patients to
wirelessly transmit the results of glucose testing including
the test result, date and time from the blood glucose meter
via a CDMA module in the blood glucose meter over the
Verizon wireless network, to a secure central database.
The results are then stored on a secure central database
and can be accessed through the internet by patients and/ or
authorized healthcare professionals, on a personal computer
running any operating system with access to the internet.
The user can review and evaluate results of blood glucose
tests and related information to aid in the management of
diabetic patients. | |
| | Results can be displayed on the computer in the form of a
Log Book report showing test results from a specified date
range, a graphical display of the patient's results and a
trending report showing within target and out of target
percentages. | |
| System
Requirements | 3. A current internet browser and internet access are required
to reach the MyGHR website. No other programs or
applications need to be installed on a computer terminal. No
cables are required. The User goes to the MyGHR website
and sets up their account. | |
| General Functions | The data is accessed via an internet browser and a secure
login portal requiring a user name and password.
The Software System consists of three levels of access or
environments of use:
1- The MyGHR System for Home use by the patient
This portal is for the patient to access their results as sent
from the meter, analyze results as compared to targets and
generate charts and graphs to show trends. | |
| | 2- The MyGHR Plus for Professional use by the healthcare
professional allows an authorized healthcare professional to
access data for patients and analyze results in terms of
meeting target levels and also to generate graphs and
charts to visualize results over a designated time period. | |
| | 3- The GHR-ADMIN is for technical support only and accessed
only by GHRS employees only. | |
| | An on-line tutorial guides the user through the setup and use
process. Patients enter information such as a target blood
glucose range. | |
| | Graphs and tables that are displayed can be printed. Alerts
can be sent via text message or email for test results if
desired. | |
| Intended Use | The Genesis Health Record System is intended to be used
as an accessory to the Genesis Health Technologies Blood
Glucose Meter, Model TD-4123 to assist in the
review and evaluation of blood glucose test results and
related information to aid in diabetes management. The
System is not intended to provide automated treatment | |
| Indications for Use | guidance or decisions.
It is indicated for use by adult diabetic patients for use in the
home and by healthcare professionals in the professional | |
| | setting. The System is not indicated for the diagnosis or
screening of diabetes. | |
| Technological
Characteristics | The GHRS uses wireless technology incorporating a CDMA
module into the meter to transmit readings over a wireless
network to a secure central server for review and analysis.
The MyGHR website portal is accessed via internet browser. | |
| Non-Clinical
Testing | Software verification and validation has been performed and
demonstrated safety, repeatability and effectiveness of the
GHRS remote database and substantial equivalency to the
predicate devices. | |
| Bench Testing | The following Verification and Validation Tests are included in
this submission:
Validation of the logbook functionality, including proper
date selection/filtering, proper display of all Reading
Types, Accuracy of display data for all reading types
and verification of all calculations. Found in GHRS V
& V Test Plan 2.21.4 pgs.: 13-17. Validation of the Test History Chart, including proper
date selection/filtering, proper display of all Reading
Types, ACCURACY of display data for ALL reading
types and verification of calculations. Found in GHRS
V & V Test Plan 2.21.4 pgs.: 17-18. Validation of the logbook functionality for the Target
Range Chart, including proper date selection/filtering,
proper display of all Reading Types, ACCURACY of
display data for ALL reading types, verification of
calculations. Found in GHRS V & V Test Plan 2.21.4
pgs.: 19-20. Validation of accuracy of all mathematical calculations
including summary data, and statistics used by the
system. Found in GHRS V & V Test Plan 2.21.5 All
pages. Validation of data accuracy from meter to server,
including ALL upload scenarios including: automatic,
delayed, and multiple for all reading types including
before meals, after meals, general and all reading
ranges including Low, in range, and High. Found in
GHRS V & V Test Plan 2,21,6 All pages. Verification of the device functionality related to data
upload and the flight safe switch mode. Found in GHT
BGM V & V Test Plan 1.13.1. | |
| Human Factors
Study | A Human Factors study was performed with 25 test Home Use participants, 25 meters, and 4 Healthcare Professionals all with average computer skills. The study evaluated the entire system setup as well as data download and 100% accuracy of the transmitted data.
An analysis of user completed tasks was performed. A user evaluation analysis incorporating a 5 point Likert Scale with measures ranging from Strongly Disagree to Strongly Agree was used.
The study was also used to confirm 100% accuracy for data transmission from the meter to the data base and data integrity when analyzed in the intended use environment. | |
| Clinical Testing | N/A | |
| Substantial Equivalence Information | | |
| Feature | Candidate Device:
GHRS | Predicate Device: PC Care
by i-SENS K100937 |
| Intended Use | The Genesis Health Record System is an accessory to blood glucose meters to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not intended to provide automated treatment guidance or decisions. The System is not indicated for the diagnosis or screening of diabetes. | The PC care™ Blood Glucose Data Management Software is a PC-based software intended for use in the home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for an effective diabetes management program. The PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care™ Blood Glucose Data Management Software allows the user to download blood glucose readings automatically from the meter to the PC. |
| Transfer data from a
blood glucose meter to a
database | Major Features of Device | |
| | Yes, automatically, from device to a remote database wirelessly over a secure
cellular network using CDMA technology. | Yes, automatically from device to PC via a special USB cable |
| Data can be analyzed by | Yes, Logbook, Logbook | Yes Logbook, Logbook |
| | | |
| user to display trends in
graph form. Multiple
types of reports can be
displayed | summary, Test history in
graph formats, Trends over
specified date range | summary, Test history in
graph formats, Trends over
specified date range |
| Data is stored in a
Database | Yes in a remote server | Yes on the local PC |
| Results and reports can
be shared with others | Yes, authorized users can log
on to MYGHR website and
view results | Yes, reports can be attached
to email or printed out. |
| Parameters can be
customized | Yes target ranges, dates
various health parameters | Yes target ranges, dates,
various health parameters |
| Software Use Indications | Home Use (patient) and
Professional Use(Healthcare
Professional) | Single or Multiple user
settings |
| Installation of Program | Not required Site is internet
based and accessed through
a web browser | Installed using a CD |
| Computer System
Requirements | Device using Windows, Mac,
iPhone, Android or similar
OS, with one of the following
approved browsers installed:
Internet Explorer 9
Mozilla Firefox 12
Apple iOS 5
Apple Safari 5.1
Google Chrome 19
Android Internet Browser 2.3 | CPU: Minimum 300 MHZ Intel
Pentium 2 Windows 95,
Windows 98, Windows ME,
Windows 2000, Windows XP,
Windows Vista and Windows
7
Minimum free hard disk
space: 60MB RAM 128MB or
higher USB port required PC
Care USB Cable
Mouse and Keyboard
Video monitor with 1024x768
pixel screen minimum and
256 colors
CD-Rom drive optional printer |
| Access to DMS | Accessed via internet on any
PC with internet connection
and approved browser | From personal computer via
program |
| Indication time of test | Yes (One of: Normal, Before
Meal, After Meal, Control
Solution) | Yes (One of: Normal, Before
Meal, After Meal, Control
Solution) |
| Technical Support | Yes | Yes |
| User Manual | Yes accessed online | Yes on program installation
CD |
| Summary of
Technological
Differences | 1. The candidate device uses wireless technology to allow the
user to instantly upload test results from the meter to the
remote database.
The predicate requires the user to connect the meter to a PC
via a USB cable to upload results stored on a local hard
drive.
-
The candidate device allows patient results to be accessed
on any computer with internet access and a current internet
browser.
The predicate device requires the patient to access their
results from the PC where the program is installed. -
The candidate device allows authorized healthcare
professionals to directly access and analyze patient results
via an internet portal and secure login screen
The predicate device requires patients to email or print out
and send reports to their healthcare professionals for review. | |
| Summary of
similarities | 1. Both devices allow patients to upload their test results from
the BGM to a database -
Both devices allow for analysis of results in table, chart and
graph form. -
Both devices are intended to assist patients and healthcare
providers in the management of diabetes. | |
| Conclusion | The candidate device has the same intended use as the
predicate device. Bench testing has validated the accuracy
and reliability of the device. A Human Factors study has
demonstrated the usability of the device by its intended user
population. Therefore, the Genesis Health Record System is
found to be substantially equivalent to the predicate device in
both intended use and performance. | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue ocument Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2013
Genesis Health Technologies, LLC c/o Kathleen Johnson, President Medical Device Approvals, Inc. P. O. Box 2042 Fairfield, IA 52556
Re: K123136
Trade/Device Name: Genesis Health Record System (GHRS) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: January 22, 2013 Received: January 30, 2013
Dear Ms. Johnson:
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.
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.
7
Page 2-Ms. Johnson
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/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,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K123136
Device Name: Genesis Health Record System
Indications for Use: The Genesis Health Record System is an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123 to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not intended to provide automated treatment guidance or decisions. The System is not indicated for the diagnosis or screening of diabetes.
Prescription Use X (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 Diagnostics and Radiological Health (UR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K123136
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