The Health-e-Connect System is intended for use in the home and clinical settings by people with diabetes and healthcare providers as an aid in the review, analysis and evaluation of historical glucose test results and associated usage data in support of an effective diabetes management program.

Device Description

The ALRT Health-e-Connect System (HeC) is an internet based blood glucose monitoring system that allows healthcare providers and patients the opportunity to review, analyze and evaluate the efficacy of a diabetes management program. It is expected that this functionality will significantly improve HbA1C levels in patients with diabetes. Note there are no physical, electrical, biocompatibility or sterility specifications for this device as it is software only. It performs two functions: it is a data management tool and a communication platform. The Health-c-Connect System is comprised of a home based application, legally marketed peripherals (blood glucose meters) and a server. The home based application software collects data from blood glucose meters and transmits the data over the home's existing internet connection where it is uploaded to the Health-e-Connect System's web-based servers. The server is a web-based application that collects, range checks, stores and displays historical patient blood sugar levels. It also allows patients, healthcare providers, patient relatives and other healthcare providers involved in the case to send messages to each other and share patient information. This communication is retrospective and not a real- time alert or alarm. The Healthe-Connect System is a tool to monitor patients remotely and motivate them through notifications.

AI/ML Overview

The ALRT Health-e-Connect System is a software-only device designed as an internet-based blood glucose monitoring system. It allows healthcare providers and patients to review, analyze, and evaluate the efficacy of a diabetes management program. The device acts as a data management tool and communication platform, collecting data from legally marketed blood glucose meters and transmitting it to web-based servers for storage and display of historical patient blood sugar levels. It also facilitates communication among patients, healthcare providers, and patient relatives.

Here is an analysis of its acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Bench Testing
View Glucometer Summary of a User: Correct Glucometer summary (checked against paper copy & calculations).	Pass (for all tested glucose meter models: Bayer Breez™, Bayer Contour™, Abbott Freestyle Freedom™, Abbott Freestyle Freedom Lite™, Abbott Freestyle Lite™, Abbott Precision Xtra™, Roche ACCU-CHEK™ Aviva, Roche ACCU-CHEK™ Compact Plus, Lifescan OneTouch™ Ultra 2, Lifescan OneTouch™ Ultra Mini).
Glucometer usage uploaded into the HeC: Correct value recorded after blood test and upload from glucometer.	Pass (for all tested glucose meter models).
Patient information and import data are not associated correctly: Log created and manually checked for each upload.	Pass (for all tested glucose meter models).
Glucose analysis is flawed and the results are not correct in the HeC-RCS: Code checked thoroughly against other algorithms for accuracy.	Pass.
Test 1: Connection/communication between glucose meter and ALRT HeC System (using manufacturers' data cable and various rated operating systems).	Pass (Verified for all 10 tested glucose meter models).
Test 2: Verification of data transfer (accuracy and completeness of data, all required fields, sent to correct account).	Pass (Verified for all 10 tested glucose meter models).
Usability / Human Factor Studies	Results of this HFS indicate that the HeC System is user friendly, is fast and easy to use and that users were able to successfully perform the various functions within the system. This included manual data entry, electronic data uploads, reports, and messaging.

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

Bench Testing: The test set for bench testing involved 10 different glucose meter models from various manufacturers (Bayer, Abbott, Roche, Lifescan). The data provenance is not explicitly stated as country of origin, but it can be inferred that these are commercially available meters. The testing appears to be prospective as it involved performing specific procedures (taking blood tests, uploading data, checking values, etc.) to verify the system's functionality.
Usability / Human Factor Studies (HFS): The test set included 22 lay users and 2 healthcare providers. The data provenance is not specified regarding country of origin, but the study was conducted to evaluate the usability of the Health-e-Connect system. This was likely prospective through surveys and observations of user interactions.

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

Bench Testing: For the "Correct Glucometer summary (checked against paper copy & calculations)" and "Glucose analysis is flawed and the results are not correct in the HeC-RCS" tests, the ground truth was established by checking against paper copies & calculations and by comparing the analysis code against other algorithms. While it implies expert knowledge in calculations and algorithm design, the number and specific qualifications of human experts involved in these direct "ground truth" determinations are not specified.
Usability / Human Factor Studies: The "ground truth" for usability was established through the feedback and successful task completion of the 22 lay users and 2 healthcare providers. These individuals served as the "experts" in evaluating user experience. Their specific qualifications beyond being "lay users" and "healthcare providers" are not detailed (e.g., specific roles or years of experience).

4. Adjudication Method for the Test Set

Bench Testing: The adjudication method for bench testing involved direct verification against established references (paper copies, calculations, other algorithms) and observations of successful data transfer and accurate association. There is no mention of a formal multi-expert adjudication method (like 2+1 or 3+1). The "Pass" results suggest a direct factual comparison rather than a consensus approach.
Usability / Human Factor Studies: The usability study relied on surveys and observations of the 22 lay users and 2 healthcare providers. The conclusion states that the system was "user friendly, fast and easy to use," implying a qualitative assessment based on the collected feedback rather than a formal multi-reader adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission does not mention any study comparing human reader performance with and without AI assistance for tasks related to interpreting glucose data. The device is a data management and communication tool, not an AI for medical image or diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of the data processing algorithms was conducted as part of the bench testing.

The test: "Glucose analysis is flawed and the results are not correct in the HeC-RCS".
The procedure: "The code which analyzes the glucometers values is checked thoroughly against other algorithms calculating the same statistics to verify accuracy."
This demonstrates an evaluation of the algorithm's accuracy in processing glucose values independently.

7. Type of Ground Truth Used

Bench Testing: The ground truth used for bench testing included:
- Manual calculations and paper records for verifying summary accuracy.
- Direct comparison with values displayed on the physical glucometers for data transfer accuracy.
- Comparison against other established algorithms for the accuracy of glucose analysis.
- Manual logging and checking for data association.
Usability / Human Factor Studies: The ground truth was user feedback and observed task completion, assessing aspects like user-friendliness, speed, and ease of use.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is a software system for data management and display, not a machine learning or AI model trained on a dataset in the conventional sense for diagnostic or predictive purposes. Its functionality is based on established logical processes for data handling and communication.

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

As there is no mention of a training set in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided document. The software's functionality is based on direct implementation of data handling rules and communication protocols rather than learning from a labeled dataset.

Summary

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K102063

OCT 1 1 2011

510(k) Summary Page 1 of 5 7-Oct-11

Official Contact:	Lawrence Weinstein, PresidentALR Technologies3350 Riverwood Pkwy, Suite 1900Atlanta GA, 30339 USATel - 804-302-4905Fax - 678-881-1418e-mail: larryw@alrt.com
Proprietary or Trade Name:	Health-e-Connect System
Common/Usual Name:	Blood Glucose Meter
Classification Name:	System, Test, Blood Glucose OTCNBW - 862.1345, Class - 2Calculator/Data Processing Module for Clinical UseJQP - 862.2100, Class - 1
Predicate Device:	K062770Copilot Health Management SystemAbbott Diabetes Care Inc.K090801Electronic House Call SystemExpress MD Solutions, LLC

Device Description:

Note there are no physical, electrical, biocompatibility or sterility specifications for this device as it is software only. It performs two functions: it is a data management tool and a communication platform.

The Health-c-Connect System is comprised of a home based application, legally marketed peripherals (blood glucose meters) and a server.

The home based application software collects data from blood glucose meters and transmits the data over the home's existing internet connection where it is uploaded to the Health-e-Connect System's web-based servers.

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510(k) Summary Page 2 of 5 7-Oct-11

The server is a web-based application that collects, range checks, stores and displays historical patient blood sugar levels. It also allows patients, healthcare providers, patient relatives and other healthcare providers involved in the case to send messages to each other and share patient information. This communication is retrospective and not a real- time alert or alarm. The Healthe-Connect System is a tool to monitor patients remotely and motivate them through notifications.

Intended Use

The Health-e-Connect System is a remote, retrospective tool to supplement a patients' care. The Health-e-Connect System is intended to be a simple "store and forward" communications platform that allows clinicians and authorized users to access a patients' information for review and feedback. The Health-e-Connect System is a tool to monitor patients remotely and motivate them through notifications. The Health-e-Connect System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare provider's judgment or treatment plan. The Health-e-Connect System is not intended to act as an emergency response system.

Indications for Use:

Patient Population:

Patient with diabetes

Environment of Use:

Home and clinical environments

Contraindications:

None

Technology:

The Health-e-Connect System is a software based data processing system. The device operates on personal computers and across the internet via encrypted communications.

Materials:

No patient contacting materials

Performance Testing

The HeC was tested with 1 different meter models. The following tests were performed as part of the verification.

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510(k) Summary Page 3 of 5 7-Oct-11

Bench Testing

Test:Procedure:	View Glucometer summary of a userCorrect Glucometer summary (checked against paper copy & calculations)
Test:Procedure:	Glucometer usage uploaded into the HECTake a blood test and check blood-sugar value on glucometer. Connectglucometer to HeC Desktop Programmer and upload. Check HeC recordedvalue.
Test:Procedure:	Patient information and import data are not associated correctlyPerformed many uploads of the glucometer. For each upload, a log iscreated, manually checked the log for the uploads.
Test:	Glucose analysis is flawed and the results are not correct in theHeC-RCS
Procedure:	The code which analyzes the glucometers values is checked thoroughlyagainst other algorithms calculating the same statistics to verify accuracy.

Glucose meter test summary

Manufacturer	Model	Test 1	Test 2	Comment
Bayer	Breez™	pass	Pass	Verified
Bayer	Contour™	pass	Pass	Verified
Abbott	Freestyle Freedom™	pass	Pass	Verified
Abbott	Freestyle Freedom Lite™	pass	Pass	Verified
Abbott	Freestyle Lite™	pass	Pass	Verified
Abbott	Precision Xtra™	pass	Pass	Verified
Roche	ACCU-CHEK™ Aviva	pass	Pass	Verified
Roche	ACCU-CHEK™ Compact Plus	pass	Pass	Verified
Lifescan	OneTouch™ Ultra 2	pass	Pass	Verified
Lifescan	OneTouch™ Ultra Mini	pass	Pass	Verified

Test 1: connection/communication between glucose meter and ALRT HeC System using manufacturers' data cable and various rated operating systems.

Test 2: verification of data transfer- accuracy and completeness of data, all required fields, sent to correct account.

Non-clinical Testing:

A series of Usability / Human Factor studies were performed with lay users and healthcare providers. Overall 22 lay users and 2 HCP were involved. The Human Factor

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510(k) Summary Page 4 of 5 7-Oct-11

Study (HFS) was intended to evaluate the usability of the Health-e-Connect (HeC) System, including aspects of user friendliness, design and so forth. The study was conducted by surveying users of the system that were able to evaluate such aspects as manual data entry, electronic data uploads, reports, messaging and other functions. Participants included patients with diabetes and caregivers.

Clinical Testing:

Clinical testing was not performed to support this submission as the HeC is a data collection device only.

Conclusions:

Bench testing: All meters passed the outlined tests.

Usability / Human Factors Study: Results of this HFS indicate that the HeC System is user friendly, is fast and easy to use and that users were able to successfully perform the various functions within the system.

Comparison to Predicates:

Indications -

The Health-e-Connect System has same indications for use at the predicate K062770.

Technology -

The HeC has the same technology, software and internet, as the predicates K062770 and K090801.

Materials -

The HeC and the predicate have no patient contact materials

Environment of Use -

The environments of use, home and clinical, are the same as the predicates K062770 and K090801.

Patient Population -

Patients with diabetes is the same patient populations as the predicate devices K062770 and K090801

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510(k) Summary

Attribute	Express MD Solutions, LLCElectronic House Call System510(k) K090801	Abbott Diabetes CareCoPilot510(k) K062770	ALR TechnologiesHealth-e-Connect510(k) unknown	Discussion of Differences
Indications forUse	The Electronic House Call System (Electronic House CallDevice + Electronic House Call Application + ElectronicHouse Call Website) is a remote, retrospective monitoringtool for supplement in a patients' care. The ElectronicHouse Call Device together with the Electronic HouseCall Application is intended to be a simple "store andforward" communications platform that allows cliniciansand privileged users to access a patients' information forreview through the Electronic House Call Website. TheElectronic House Call Device is a tool to monitor patients'remotely and motivate them through education andreminders. The Electronic House Call System allowspatients to measure vital signs without assistance fromtheir healthcare provider. The Electronic House CallSystem is not intended to replace existing treatments orconsultations, nor is it to be used as a substitute for aqualified healthcare professional's judgment/treatmentplan. The Electronic House Call System is also notintended to act as an emergency response system.	The CoPilot Health Management System isintended for use in the home and clinical settingsby people with diabetes and healthcareprofessionals as an aid in the review, analysis andevaluation of historical glucose test results insupport of an effective diabetes managementprogram.	The Health-e-Connect System is intended for use inthe home and clinical settings by people withdiabetes and healthcare providers as an aid in thereview, analysis and evaluation of historical glucosetest results and associated usage data in support ofan effective diabetes management program.	Equivalent to K090801 andK062770Connects to blood glucose meter
Environmentsof use	Home and clinical environments (not explicitly stated)	Home and clinical environments (not explicitlystated)	Home and clinical environments	Same
Data Sources	Various legally marketed devices	Keyboard entry and blood glucose meters	Keyboard entry and blood glucose meters	Same as K062770
Connectivity	Various devices to computer	BG meters to computer	BG meters to computer	Health-e-Connect provides a lesscumbersome, more reliable meansof communication
Output	Telephone line or other identified method (existing high-speed connection in patient's home)	Computer to health care provider via printingfaxing or emailing	Computer to computer via internet	Health-e-Connect provides a lesscumbersome, more reliable meansof communication
Output	Email to clinician	Various representations of historical bloodglucose values and statistics.	Various representations of historical blood glucosevalues and statistics.Email or SMS message to patient	Similar to K062770
Prescriptive	Yes	No	No	Same as K062770

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

ALR Technologies c/o Promedic Inc. Paul Dryden 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K102063 Trade name: Health-e-Connect System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class H Product Code: NBW. JQP Dated: September 22, 2011 Received: September 23, 2011

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 1 1 2011

Dear Mr. Dryden:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K102063

Device Name:

Health-e-Connect System

Indications for Use:

Prescription Use	or	Over-the-counter use XX
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102063

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.