GENESIS HEALTH RECORD SYSTEM, (GHRS)

K123136 · Genesis Health Technologies · NBW · Mar 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123136
• Device Name: GENESIS HEALTH RECORD SYSTEM, (GHRS)
• Applicant: Genesis Health Technologies
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 guidance or decisions.

Device Story

The Genesis Health Record System (GHRS) is an internet-browser-based data management system used as an accessory to the Genesis Health Technologies Blood Glucose Meter (Model TD-4123). The meter transmits glucose test results, dates, and times wirelessly via an integrated CDMA module over the Verizon cellular network to a secure central database. Patients and authorized healthcare professionals access this data via a secure web portal (MyGHR) using any internet-connected computer. The system provides logbooks, graphical displays, and trending reports (within/out-of-target percentages) to aid in diabetes management. It does not provide automated treatment decisions. The system benefits patients by enabling remote data sharing with clinicians, eliminating the need for manual logbooks or physical connection to a PC.

Clinical Evidence

No clinical data. Bench testing included verification and validation of logbook functionality, data filtering, display accuracy, and mathematical calculations. Data transmission accuracy from meter to server was validated across multiple scenarios (automatic, delayed, multiple uploads). A human factors study with 25 home-use participants and 4 healthcare professionals confirmed system setup, data download, and 100% data transmission accuracy.

Technological Characteristics

Web-based software accessed via internet browser. Uses CDMA wireless module in the blood glucose meter for data transmission to a secure central server. Supports Windows, Mac, iOS, and Android platforms. No local software installation required. Connectivity via cellular network.

Indications for Use

Indicated for adult diabetic patients for use in the home and by healthcare professionals in the professional setting to assist in the review and evaluation of blood glucose test results. Not indicated for the diagnosis or screening of diabetes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PC Care by i-SENS (K100937)

Submission Summary (Full Text)

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# K123136

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7 2013 MAR

## 510(k) Summary

| Submitter<br>807.92(a)(1) | Nathan Cross CEO<br>Genesis Health Technologies, Inc.<br>1640 McCracken Blvd.<br>Paducah, KY 42001<br>888-263-0003<br>[e-mail] | |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kathleen Johnson<br>Medical Device Approvals, Inc.<br>PO Box 2042<br>Fairfield, IA 52556<br>641-472-0775<br>[e-mail] | |
| Date Prepared | December 12, 2012 | |
| Trade Name<br>807.92(a)(2) | Genesis Health Record System (GHRS) | |
| Common Name | Data Management System | |
| Classification Name<br>807.92(a)(2) | 21 CFR 862.2100 Calculator/data processing module for clinical use<br>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<br>JQP-Calculator/Data Processing Module for Clinical Use | |
| Predicate Device<br>807.92(a)(3) | ISENS PC care blood Glucose data Management Software<br>K100937 | |
| Device Description<br>807.92(a)(4) | 1. The Genesis Health Record System (GHRS) is an internet<br>browser based data management system for use with the<br>Genesis Health Technologies Blood Glucose Meter Cleared<br>under K121224. | |
| Operating Principle | 2. The GHRS data management system allows patients to<br>wirelessly transmit the results of glucose testing including<br>the test result, date and time from the blood glucose meter<br>via a CDMA module in the blood glucose meter over the<br>Verizon wireless network, to a secure central database.<br><br>The results are then stored on a secure central database<br>and can be accessed through the internet by patients and/ or<br>authorized healthcare professionals, on a personal computer<br>running any operating system with access to the internet.<br>The user can review and evaluate results of blood glucose<br>tests and related information to aid in the management of<br>diabetic patients. | |
| | Results can be displayed on the computer in the form of a<br>Log Book report showing test results from a specified date<br>range, a graphical display of the patient's results and a<br>trending report showing within target and out of target<br>percentages. | |
| System<br>Requirements | 3. A current internet browser and internet access are required<br>to reach the MyGHR website. No other programs or<br>applications need to be installed on a computer terminal. No<br>cables are required. The User goes to the MyGHR website<br>and sets up their account. | |
| General Functions | The data is accessed via an internet browser and a secure<br>login portal requiring a user name and password.<br>The Software System consists of three levels of access or<br>environments of use:<br>1- The MyGHR System for Home use by the patient<br>This portal is for the patient to access their results as sent<br>from the meter, analyze results as compared to targets and<br>generate charts and graphs to show trends. | |
| | 2- The MyGHR Plus for Professional use by the healthcare<br>professional allows an authorized healthcare professional to<br>access data for patients and analyze results in terms of<br>meeting target levels and also to generate graphs and<br>charts to visualize results over a designated time period. | |
| | 3- The GHR-ADMIN is for technical support only and accessed<br>only by GHRS employees only. | |
| | An on-line tutorial guides the user through the setup and use<br>process. Patients enter information such as a target blood<br>glucose range. | |
| | Graphs and tables that are displayed can be printed. Alerts<br>can be sent via text message or email for test results if<br>desired. | |
| Intended Use | The Genesis Health Record System is intended to be used<br>as an accessory to the Genesis Health Technologies Blood<br>Glucose Meter, Model TD-4123 to assist in the<br>review and evaluation of blood glucose test results and<br>related information to aid in diabetes management. The<br>System is not intended to provide automated treatment | |
| Indications for Use | guidance or decisions.<br>It is indicated for use by adult diabetic patients for use in the<br>home and by healthcare professionals in the professional | |
| | setting. The System is not indicated for the diagnosis or<br>screening of diabetes. | |
| Technological<br>Characteristics | The GHRS uses wireless technology incorporating a CDMA<br>module into the meter to transmit readings over a wireless<br>network to a secure central server for review and analysis.<br>The MyGHR website portal is accessed via internet browser. | |
| Non-Clinical<br>Testing | Software verification and validation has been performed and<br>demonstrated safety, repeatability and effectiveness of the<br>GHRS remote database and substantial equivalency to the<br>predicate devices. | |
| Bench Testing | The following Verification and Validation Tests are included in<br>this submission:<br>Validation of the logbook functionality, including proper<br>date selection/filtering, proper display of all Reading<br>Types, Accuracy of display data for all reading types<br>and verification of all calculations. Found in GHRS V<br>& V Test Plan 2.21.4 pgs.: 13-17. Validation of the Test History Chart, including proper<br>date selection/filtering, proper display of all Reading<br>Types, ACCURACY of display data for ALL reading<br>types and verification of calculations. Found in GHRS<br>V & V Test Plan 2.21.4 pgs.: 17-18. Validation of the logbook functionality for the Target<br>Range Chart, including proper date selection/filtering,<br>proper display of all Reading Types, ACCURACY of<br>display data for ALL reading types, verification of<br>calculations. Found in GHRS V & V Test Plan 2.21.4<br>pgs.: 19-20. Validation of accuracy of all mathematical calculations<br>including summary data, and statistics used by the<br>system. Found in GHRS V & V Test Plan 2.21.5 All<br>pages. Validation of data accuracy from meter to server,<br>including ALL upload scenarios including: automatic,<br>delayed, and multiple for all reading types including<br>before meals, after meals, general and all reading<br>ranges including Low, in range, and High. Found in<br>GHRS V & V Test Plan 2,21,6 All pages. Verification of the device functionality related to data<br>upload and the flight safe switch mode. Found in GHT<br>BGM V & V Test Plan 1.13.1. | |
| Human Factors<br>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.<br>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.<br>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:<br>GHRS | Predicate Device: PC Care<br>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<br>blood glucose meter to a<br>database | Major Features of Device | |
| | Yes, automatically, from device to a remote database wirelessly over a secure<br>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<br>graph form. Multiple<br>types of reports can be<br>displayed | summary, Test history in<br>graph formats, Trends over<br>specified date range | summary, Test history in<br>graph formats, Trends over<br>specified date range |
| Data is stored in a<br>Database | Yes in a remote server | Yes on the local PC |
| Results and reports can<br>be shared with others | Yes, authorized users can log<br>on to MYGHR website and<br>view results…