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.

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.
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.
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.

AI/ML Overview

The Genesis Health Record System (GHRS) is a data management system intended to be an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123. It assists 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 in the home and by healthcare professionals in a professional setting. The system is not intended to provide automated treatment guidance or decisions, nor is it indicated for the diagnosis or screening of diabetes.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GHRS device are inferred from the non-clinical testing performed, focusing on software verification and validation, as well as human factors testing to ensure usability and data integrity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Software Functionality	Logbook Functionality: Proper date selection/filtering, proper display of all Reading Types (before meals, after meals, general), accuracy of display data for all reading types, and verification of all calculations.	Validation performed with results in GHRS V & V Test Plan 2.21.4 (pgs 13-17). (Implicitly found compliant as part of substantial equivalence claim)
	Test History Chart Functionality: Proper date selection/filtering, proper display of all Reading Types, accuracy of display data for all reading types, and verification of calculations.	Validation performed with results in GHRS V & V Test Plan 2.21.4 (pgs 17-18). (Implicitly found compliant as part of substantial equivalence claim)
	Target Range Chart Functionality: Proper date selection/filtering, proper display of all Reading Types, accuracy of display data for all reading types, and verification of calculations.	Validation performed with results in GHRS V & V Test Plan 2.21.4 (pgs 19-20). (Implicitly found compliant as part of substantial equivalence claim)
	Mathematical Calculation Accuracy: Accuracy of all mathematical calculations, including summary data and statistics used by the system.	Validation performed with results in GHRS V & V Test Plan 2.21.5 (All pages). (Implicitly found compliant as part of substantial equivalence claim)
Data Transfer & Integrity	Data Accuracy (Meter to Server): Accuracy of data from meter to server, including all upload scenarios (automatic, delayed, multiple) for all reading types (before meals, after meals, general) and all reading ranges (Low, in range, High).Device Functionality (Upload & Flight Safe Switch): Verification of device functionality related to data upload and the flight safe switch mode.	Validation performed with results in GHRS V & V Test Plan 2.21.6 (All pages).Verification performed with results in GHT BGM V & V Test Plan 1.13.1. (Implicitly found compliant as part of substantial equivalence claim)
Human Factors/Usability	Usability of Entire System: Evaluation of the entire system setup, data download, and 100% accuracy of transmitted data by intended users (Home Use patients and Healthcare Professionals).	A Human Factors study with 25 Home Use participants (using 25 meters) and 4 Healthcare Professionals found 100% accuracy of transmitted data. An analysis of user-completed tasks was performed, and a 5-point Likert Scale was used for user evaluation. (Implicitly found compliant as part of substantial equivalence claim)
Safety & Effectiveness	Software verification and validation demonstrated safety, repeatability, and effectiveness.	Bench testing and Human Factors study concluded safety, repeatability, and effectiveness, leading to a finding of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily describes validation and verification activities rather than a traditional "test set" for performance evaluation in the way one might evaluate an AI/ML model for diagnostic accuracy.

For Software Functionality/Data Transfer: No specific "test set" sample size of patient data is mentioned. The validation involves testing algorithms and software functions described in specific V&V plans (e.g., GHRS V & V Test Plan 2.21.4, 2.21.5, 2.21.6, GHT BGM V & V Test Plan 1.13.1). These tests would likely involve simulated or artificially generated data to cover all defined scenarios and parameters. The provenance of this data is not specified, but it would be internal to the company's development and testing process.
For Human Factors:
- Sample Size: 25 Home Use participants and 4 Healthcare Professionals.
- Data Provenance: The study was conducted using the actual device and intended users, likely in a controlled environment. The country of origin is not explicitly stated but can be assumed to be within the US given the submission to the FDA. The data generated was prospective, as it involved participants performing tasks with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given the nature of the device (a data management system for blood glucose meters), the "ground truth" for the software functionality tests would be the correct operation and calculation according to predefined specifications and mathematical rules.

Software Functionality: The ground truth would be established by the software designers and engineers who define the expected behavior and calculations. The number and qualifications of these individuals are not specified in the document.
Human Factors: The ground truth for the human factors study's data accuracy aspect was 100% accuracy of transmitted data, which would be determined by comparing the readings taken from the physical meter to the data stored in the database. This doesn't necessarily involve "experts" establishing a subjective ground truth, but rather technical verification.

4. Adjudication Method for the Test Set

Software Functionality: Not applicable in the sense of expert adjudication. Software verification and validation typically involve comparing system output against predefined behavioral requirements and calculated results for known inputs. Deviations would be considered defects.
Human Factors: The human factors study involved "an analysis of user completed tasks" and a "user evaluation analysis incorporating a 5 point Likert Scale." This suggests direct observation and user feedback rather than an adjudication method for disagreements among multiple evaluators. The 100% data accuracy claim would be a direct comparison, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a data management system, not a diagnostic AI/ML algorithm that assists human readers in interpreting medical cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, standalone testing, in the form of software verification and validation, was primarily done for the core functionality of the device. The "algorithm" in this context refers to the data processing, display, and calculation functions of the software. These were tested independent of a human user's diagnostic interpretation. The human factors study separately validated the human-in-the-loop (i.e., user interaction) aspects, but the core data handling and processing would have been verified as a standalone system function.

7. The Type of Ground Truth Used

Software Functionality: The ground truth was based on predefined design specifications and mathematical correctness. This refers to the accuracy of displayed data, calculations, filtering, and reporting matching the expected behavior and standards for blood glucose data management.
Data Transfer: The ground truth was direct comparison of meter readings to stored database values to confirm 100% accuracy of transmission and integrity.
Human Factors: The ground truth for the data accuracy component was the actual meter reading compared to the transmitted and displayed data. For usability, the ground truth was the successful completion of tasks by users and their subjective feedback via the Likert scale.

8. The Sample Size for the Training Set

Not applicable. This device is a data management system and not an AI/ML algorithm that requires a training set in the conventional sense (i.e., for learning patterns from data to make predictions or classifications). Its functionality is based on programmed logic and calculations, not trained models.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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K123136

7 2013 MAR

510(k) Summary

Submitter807.92(a)(1)	Nathan Cross CEOGenesis Health Technologies, Inc.1640 McCracken Blvd.Paducah, KY 42001888-263-0003ncross@genesishealthcaretechnologies.com
Contact Person	Kathleen JohnsonMedical Device Approvals, Inc.PO Box 2042Fairfield, IA 52556641-472-0775kathleen@mdapprovals.com
Date Prepared	December 12, 2012
Trade Name807.92(a)(2)	Genesis Health Record System (GHRS)
Common Name	Data Management System
Classification Name807.92(a)(2)	21 CFR 862.2100 Calculator/data processing module for clinical useClass II regulated as an accessory to Blood Glucose Meters
Classification Panel	Clinical Chemistry 71
Product Code	NBW-System test Blood Glucose Over the CounterJQP-Calculator/Data Processing Module for Clinical Use
Predicate Device807.92(a)(3)	ISENS PC care blood Glucose data Management SoftwareK100937
Device Description807.92(a)(4)	1. The Genesis Health Record System (GHRS) is an internetbrowser based data management system for use with theGenesis Health Technologies Blood Glucose Meter Clearedunder K121224.
Operating Principle	2. The GHRS data management system allows patients towirelessly transmit the results of glucose testing includingthe test result, date and time from the blood glucose metervia a CDMA module in the blood glucose meter over theVerizon wireless network, to a secure central database.The results are then stored on a secure central databaseand can be accessed through the internet by patients and/ orauthorized healthcare professionals, on a personal computerrunning any operating system with access to the internet.The user can review and evaluate results of blood glucosetests and related information to aid in the management ofdiabetic patients.
	Results can be displayed on the computer in the form of aLog Book report showing test results from a specified daterange, a graphical display of the patient's results and atrending report showing within target and out of targetpercentages.
SystemRequirements	3. A current internet browser and internet access are requiredto reach the MyGHR website. No other programs orapplications need to be installed on a computer terminal. Nocables are required. The User goes to the MyGHR websiteand sets up their account.
General Functions	The data is accessed via an internet browser and a securelogin portal requiring a user name and password.The Software System consists of three levels of access orenvironments of use:1- The MyGHR System for Home use by the patientThis portal is for the patient to access their results as sentfrom the meter, analyze results as compared to targets andgenerate charts and graphs to show trends.
	2- The MyGHR Plus for Professional use by the healthcareprofessional allows an authorized healthcare professional toaccess data for patients and analyze results in terms ofmeeting target levels and also to generate graphs andcharts to visualize results over a designated time period.
	3- The GHR-ADMIN is for technical support only and accessedonly by GHRS employees only.
	An on-line tutorial guides the user through the setup and useprocess. Patients enter information such as a target bloodglucose range.
	Graphs and tables that are displayed can be printed. Alertscan be sent via text message or email for test results ifdesired.
Intended Use	The Genesis Health Record System is intended to be usedas an accessory to the Genesis Health Technologies BloodGlucose Meter, Model TD-4123 to assist in thereview and evaluation of blood glucose test results andrelated information to aid in diabetes management. TheSystem 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 thehome and by healthcare professionals in the professional
	setting. The System is not indicated for the diagnosis orscreening of diabetes.
TechnologicalCharacteristics	The GHRS uses wireless technology incorporating a CDMAmodule into the meter to transmit readings over a wirelessnetwork to a secure central server for review and analysis.The MyGHR website portal is accessed via internet browser.
Non-ClinicalTesting	Software verification and validation has been performed anddemonstrated safety, repeatability and effectiveness of theGHRS remote database and substantial equivalency to thepredicate devices.
Bench Testing	The following Verification and Validation Tests are included inthis submission:Validation of the logbook functionality, including properdate selection/filtering, proper display of all ReadingTypes, Accuracy of display data for all reading typesand verification of all calculations. Found in GHRS V& V Test Plan 2.21.4 pgs.: 13-17. Validation of the Test History Chart, including properdate selection/filtering, proper display of all ReadingTypes, ACCURACY of display data for ALL readingtypes and verification of calculations. Found in GHRSV & V Test Plan 2.21.4 pgs.: 17-18. Validation of the logbook functionality for the TargetRange Chart, including proper date selection/filtering,proper display of all Reading Types, ACCURACY ofdisplay data for ALL reading types, verification ofcalculations. Found in GHRS V & V Test Plan 2.21.4pgs.: 19-20. Validation of accuracy of all mathematical calculationsincluding summary data, and statistics used by thesystem. Found in GHRS V & V Test Plan 2.21.5 Allpages. Validation of data accuracy from meter to server,including ALL upload scenarios including: automatic,delayed, and multiple for all reading types includingbefore meals, after meals, general and all readingranges including Low, in range, and High. Found inGHRS V & V Test Plan 2,21,6 All pages. Verification of the device functionality related to dataupload and the flight safe switch mode. Found in GHTBGM V & V Test Plan 1.13.1.
Human FactorsStudy	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 Careby 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 ablood glucose meter to adatabase	Major Features of Device
	Yes, automatically, from device to a remote database wirelessly over a securecellular 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 ingraph form. Multipletypes of reports can bedisplayed	summary, Test history ingraph formats, Trends overspecified date range	summary, Test history ingraph formats, Trends overspecified date range
Data is stored in aDatabase	Yes in a remote server	Yes on the local PC
Results and reports canbe shared with others	Yes, authorized users can logon to MYGHR website andview results	Yes, reports can be attachedto email or printed out.
Parameters can becustomized	Yes target ranges, datesvarious health parameters	Yes target ranges, dates,various health parameters
Software Use Indications	Home Use (patient) andProfessional Use(HealthcareProfessional)	Single or Multiple usersettings
Installation of Program	Not required Site is internetbased and accessed througha web browser	Installed using a CD
Computer SystemRequirements	Device using Windows, Mac,iPhone, Android or similarOS, with one of the followingapproved browsers installed:Internet Explorer 9Mozilla Firefox 12Apple iOS 5Apple Safari 5.1Google Chrome 19Android Internet Browser 2.3	CPU: Minimum 300 MHZ IntelPentium 2 Windows 95,Windows 98, Windows ME,Windows 2000, Windows XP,Windows Vista and Windows7Minimum free hard diskspace: 60MB RAM 128MB orhigher USB port required PCCare USB CableMouse and KeyboardVideo monitor with 1024x768pixel screen minimum and256 colorsCD-Rom drive optional printer
Access to DMS	Accessed via internet on anyPC with internet connectionand approved browser	From personal computer viaprogram
Indication time of test	Yes (One of: Normal, BeforeMeal, After Meal, ControlSolution)	Yes (One of: Normal, BeforeMeal, After Meal, ControlSolution)
Technical Support	Yes	Yes
User Manual	Yes accessed online	Yes on program installationCD
Summary ofTechnologicalDifferences	1. The candidate device uses wireless technology to allow theuser to instantly upload test results from the meter to theremote database.The predicate requires the user to connect the meter to a PCvia a USB cable to upload results stored on a local harddrive.2. The candidate device allows patient results to be accessedon any computer with internet access and a current internetbrowser.The predicate device requires the patient to access theirresults from the PC where the program is installed.3. The candidate device allows authorized healthcareprofessionals to directly access and analyze patient resultsvia an internet portal and secure login screenThe predicate device requires patients to email or print outand send reports to their healthcare professionals for review.
Summary ofsimilarities	1. Both devices allow patients to upload their test results fromthe BGM to a database2. Both devices allow for analysis of results in table, chart andgraph form.3. Both devices are intended to assist patients and healthcareproviders in the management of diabetes.
Conclusion	The candidate device has the same intended use as thepredicate device. Bench testing has validated the accuracyand reliability of the device. A Human Factors study hasdemonstrated the usability of the device by its intended userpopulation. Therefore, the Genesis Health Record System isfound to be substantially equivalent to the predicate device inboth 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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.