The Health-e-Connect System with IDA 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.

The Insulin Dose Adjustment (IDA) feature is intended only for insulin-requiring Type 2 diabetes patients to provide the physician with two reference doses.

The IDA feature is not indicated for patients who utilize insulin pumps and it is limited to adults with Type 2 diabetes on fixed dose regimen of insulin.

The Health-e-Connect System with IDA is for patients under the supervision of a physician / healthcare provider trained in the management of diabetes. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

Device Description

The ALRT Health-e-Connect System (HeC) allows healthcare providers, ALRT staff, and other authorized caregivers to remotely monitor the blood glucose values of patients with diabetes and therefore can assist healthcare providers in making adjustments to the patient's care plan based upon trends in the patient's blood glucose data. There are no physical, electrical, biocompatible, or sterility specifications for this device as it is software only.

The original Health-e-Connect system (K102063) performed two functions:

A data management tool and
A communication platform (Health-e-Connect Remote Care System).

Modification:
The proposed modification is to add a module - Insulin Dose Adjustment (IDA) - to the Healthe- Connect System.

This is an additional module of software that monitors patient blood glucose levels uploaded from the patient's blood glucose meter, to ascertain whether the patient's current insulin dose may or may not be optimal. If trends in the patient's blood glucose are outside of the guidelines set by the AACE and ADA, the patient is flagged for a potential insulin dose adjustment. The IDA system will then employ the AACE and ADA algorithms to calculate reference doses that can be compared with the patient's current insulin dose. If there is an inconsistency between the patient's current insulin dose as compared to the reference doses calculated by AACE and ADA algorithms, this discrepancy will be flagged and an alert sent to the managing HCP requesting an insulin dose review.

AI/ML Overview

The provided text describes a 510(k) submission for the "Health-e-Connect System with IDA (Insulin Dose Adjustment)". While it details the device, its intended use, and a comparison to predicate devices, it does not contain the specific acceptance criteria or an explicit study that proves the device meets those criteria with quantitative performance metrics.

The document discusses "Verification and validation testing" and a "Human Factors / Usability study" but does not provide details on the specific performance outcomes of these tests in relation to predefined acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific numerical targets.

Therefore, I cannot populate the requested table or answer most of the questions directly from the provided text.

Here's what can be inferred or stated based on the given information, with limitations:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicit in the document. The document states "Verification testing was performed based on FDA guidance" and "Performance testing performed and all tests showed satisfactory results" for predicates, implying that the new device also met a "satisfactory" level of performance, but no specific criteria or quantitative results are provided.	Not explicit in the document. No quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity, agreement rates) are provided for the IDA feature's performance against any defined criteria.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions the device monitors "blood glucose levels uploaded from the patient's blood glucose meter," implying real-world data, but no specifics on the test set's origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The IDA feature uses "AACE and ADA algorithms to calculate reference doses." This suggests the "ground truth" for the calculated doses is based on these established clinical guidelines, rather than expert human interpretation of individual cases for the purpose of a test set.

4. Adjudication method for the test set:

Not specified. Given that the IDA feature calculates reference doses based on established algorithms (AACE and ADA), it's unlikely a traditional human adjudication process for a test set was applied in the same way it would be for an AI model that interprets medical images. The "ground truth" is algorithmic.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study is not mentioned. The device's function is to provide "reference doses" to a physician, not to interpret complex medical data like images that would typically necessitate an MRMC study for human reader performance evaluation.

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

The "Nonclinical Performance Testing" and "Verification and validation testing" suggest an evaluation of the software's functionality, which would be a form of standalone testing for the algorithm's calculation accuracy of reference doses. However, no specific performance results are provided. The function of the IDA feature is to "employ the AACE and ADA algorithms to calculate reference doses," so its standalone performance would be about its fidelity to these algorithms.

7. The type of ground truth used:

The ground truth for the IDA feature's calculations appears to be based on the guidelines and algorithms established by the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA). The device calculates "reference doses" using these established guidelines.

8. The sample size for the training set:

Not specified. The document primarily describes an algorithmic approach based on existing clinical guidelines rather than a deep learning model requiring a large training set in the conventional sense.

9. How the ground truth for the training set was established:

Not explicitly a "training set" in the machine learning sense. The "ground truth" for the IDA feature's logic is derived from and established by the AACE and ADA guidelines/algorithms. The system "employs" these existing expert-developed algorithms.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2017

ALR Technologies % Paul Drvden Consultant ALR Technologies 7400 Beaufont Springs Drive, Suite 300 Richmond, Virginia 23225

Re: K163664

Trade/Device Name: Health-e-Connect System with IDA (Insulin Dose Adjustment) Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: September 4, 2017 Received: September 6, 2017

Dear Paul 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Tara A. Ryan -S 2017.09.18 20:47:39 -04'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163664

Device Name

Health-e-Connect System with IDA (Insulin dose adjustment)

Indications for Use (Describe)

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

The Insulin Dose Adjustment (IDA) feature is intended only for insulin-requiring Type 2 diabetes patients to provide the physician with two reference doses.

The IDA feature is not indicated for patients who utilize insulin pumps and it is limited to adults with Type 2 diabetes on fixed dose regimen of insulin.

The Health-e-Connect System with IDA is for patients under the supervision / healthcare provider trained in the management of diabetes. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K163664

Date Prepared: September 15, 2017

ALR Technologies, Inc. 7400 Beaufont Springs Drive, Suite 300 Richmond, VA 23225 Tel - (203) 762-1073

Official Contact:	Sidney Chan, CEO and President
Proprietary or Trade Name:	Health-e-Connect System with IDA (Insulin dose adjustment)
Common/Usual Name:	Drug Dose Calculator
Classification Name:	21CFR 868.1890 - Predictive pulmonary-function value calculatorNDC - Drug dose calculator, Class II
Primary Predicate:	K082512 – Dimensional Dosing Systems – My Insulin Doser/IDS
Secondary Predicate:	K011571 – Dimensional Dosing Systems – TrxF Intelligent Dosing Systems (IDS)K102063 - ALR Health-e-Connect

Device Description:

The original Health-e-Connect system (K102063) performed two functions:

1. A data management tool and
1. A communication platform (Health-e-Connect Remote Care System).

Modification:

The proposed modification is to add a module - Insulin Dose Adjustment (IDA) - to the Healthe- Connect System.

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Indications for Use:

The Insulin Dose Adjustment (IDA) feature is intended only for insulin-requiring Type 2 diabetes patients to provide the physician with two reference doses.

The IDA feature is not indicated for patients who utilize insulin pumps and it is limited to adults with Type 2 diabetes on fixed dose regimen of insulin.

Environments of use:

Home and clinical settings

Substantial Equivalence Discussion:

The following table compares the key features of the proposed device and the predicate devices:

Attribute	Primary Predicate	Secondary Predicates		Proposed
	Dimensional DosingSystems My InsulinDoser / IDS K082512	Dimensional DosingSystems TRxFIntelligent DosingSystems (IDS)K011571	ALRTechnologiesHealth-e-ConnectK102063	ALRTechnologiesHealth-e-Connect withIDA
Classification	NDCDose calculator CFR868.1890	NDCDose calculator CFR868.1890	NWB / JQPGlucose testsystem CFR862.1345	NDCDose calculator CFR868.1890
Intended use	Dose calculatorInsulin	Dose calculatorInsulin	Glucose test system	Dose calculatorInsulin
Indicationsfor Use	My Insulin Doser/IDSallows a diabeticpatient to calculate thebest next dose ofinsulin to achieve apersonal glucosetarget.	The Intelligent DosingSystem (IDS) is a three-part software suitecomprised of DoseRx,InterchangeRx andPracticePrescribeRx. TheDQseRx is designed foruse by trained cliniciansto calculate anyindividual patient'soptimal next dose forany given agent. TheInterchangeRxisdesigned to switch apatient from one brandof agent to another whilemaintaining the	The Health-e-ConnectSystem is intended foruse in the home andclinical settings bypeople with diabetesand healthcareproviders as an aid inthe review, analysisand evaluation orhistorical glucose testresults and associatedusage data in supportof an effectivediabetes managementprogram.	The Health-e-ConnectSystem with IDA isintended for use in thehome and clinicalsettings by people withdiabetes and healthcareproviders as an aid in thereview, analysis, andevaluation of historicalglucose test results andassociated usage data insupport of an effectivediabetes managementprogram.The Insulin DoseAdjustment (IDA)feature is intended only
		therapeutic effect of theoriginal agent. ThePracticePrescirbeRx is adosing simulator thatoffers graded prescribertraining of next dosecalculation scenarioswith scalable patientresponse and surrogatemarker inputs that allowsthe healthcare providerto gain guided andmeasured experience incalculating the next dosefor a new or infrequentlyused drug.The IDS is not asubstitute for clinicalreasoning. The IDS is anaid for trained cliniciansbased upon significantand properly entereddata.Final drug doserecommendations fora patient must be madeonly after carefulconsideration of the fullclinical status of thepatient. No medicaldecision should be basedsolely upon the resultsprovided by this softwareprogram.		for insulin-requiringType 2 diabetes patientsto provide the physicianwith two referencedoses.The IDA feature is notindicated for patientswho utilize insulinpumps and it is limitedto adults with Type 2diabetes on fixed doseregimen of insulin.The Health-e-ConnectSystem with IDA is forpatients under thesupervision of aphysician / healthcareprovider trained in themanagement of diabetes.Final drug doserecommendations for apatient must be madeonly after carefulconsideration of the fullclinical status of thepatient. No medicaldecision should be basedsolely upon the resultsprovided by thissoftware program.
TargetPopulation	Diabetic patients	Healthcare professionals	HealthcareProfessionalDiabetics	HealthcareProfessionalAdult Type 2diabetics
Environmentof use	Home	Healthcare facility	ClinicalenvironmentsHome	Clinicalenvironments Home
Prescriptionuse	Yes	Yes	No	Yes
Technology	SoftwareMajor Level ofConcern	SoftwareMajor Level of Concern	SoftwareModerate Level ofConcern	SoftwareMajor Level of Concern
Data Sources	Blood glucose meterKeyboard entry	Blood glucose meterKeyboard entry	Blood glucose meterKeyboard entry	Blood glucose meterKeyboard entry
Data type	Real-time	Real-timeHistorical	Historical	Historical
Doseadjustments	Patient receives bestnext dose data	Calculated andcontrolled by the doctor	No dosing	Dose adjustmentpresented to doctorfor investigation thenprescription changedandcommunicated with thepatient
				patient by the doctor
Basis ofadjustment	No information	No information	N/A	Guidelines from AACEand ADA are used onthe user's A1c andglucose values toform anadjustmentrecommendation
Connectivity	Computer to computer via internet	Computer to computer via internet	Blood Glucose meter tocomputerComputer to computervia internet	Blood Glucose meter tocomputerComputer to computervia internet
Data seen by	Healthcare provider	Healthcare provider	Healthcareprovider Variousrepresentations ofhistorical bloodglucose values andstatisticsALRT StaffEmail and SMSmessage to patient	HealthcareproviderVariousrepresentationsofhistorical blood glucosevalues and statisticsIDA utilizes AACE andADA guidelines to alertmanaging clinicianregarding dosing,sending alertsALRT StaffEmail and SMS messageto patient
PerformanceTesting	Performance testingperformed and alltests showedsatisfactoryresults	Performance testingperformed and all testsshowed satisfactoryresults	SoftwareVerification andValidation	SoftwareVerificationand Validation
HumanFactors /Usability	Label comprehension	Not known	Lay user and Healthcareproviders	Healthcareprovides for IDAfeatureLay users do not see IDAfeature

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Technology – All the devices are software and internet based technologies.

Discussion – The technology is similar to the primary predicate Dimensional Dosing Systems My Insulin Doser / IDS, K082512 which is also software and internet based. The proposed device collects data from the patient's Blood Glucose meter which is similar to the predicate K102063 Health-e-Connect System. Differences - The differences are limited and do not raise different questions of safety and effective compare to the predicate devices.

Patient Population – Adult with Type 2 diabetes on fixed dose insulin

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Discussion - The patient population for the IDA feature is limited to Type 2 diabetes adults on fixed dose insulin and not on insulin pumps. The primary predicate Dimensional Dosing Systems My Insulin Doser / IDS, K082512, is for diabetic patients and does not state a patient limitation.

Differences - The difference in patient population can be considered as a subset of the population of the predicate device. This difference does not raise different questions of safety and effectiveness.

Nonclinical Performance Testing

Verification and validation testing

The subject device is web based software. Verification testing was performed based on FDA guidance:

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Human Factors / Usability

A Human Factors / usability study was performed with a healthcare professional user group based on FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices.

Biocompatibility / Materials

No patient contact materials

Substantial Equivalence Conclusion

The comparison to the predicate devices as well as the software performance testing has demonstrated that the proposed ALR Technologies Health-e-Connect with IDA are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).