Who is the manufacturer of Health-e-Connect System with IDA?

Alr Technologies filed the 510(k) submission for Health-e-Connect System with IDA (K163664).

What is the FDA product code for Health-e-Connect System with IDA?

NDC. It is classified under 21 CFR 868.1890 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Health-e-Connect System with IDA?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Health-e-Connect System with IDA?

Dimensional Dosing Systems My Insulin Doser/IDS (K082512); Dimensional Dosing Systems TrxF Intelligent Dosing Systems (IDS) (K011571); ALR Health-e-Connect (K102063).

Who can help prepare an FDA 510(k) submission like Health-e-Connect System with IDA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Health-e-Connect System with IDA

K163664 · Alr Technologies · NDC · Sep 18, 2017 · Anesthesiology

Device Facts

Record ID	K163664
Device Name	Health-e-Connect System with IDA
Applicant	Alr Technologies
Product Code	NDC · Anesthesiology
Decision Date	Sep 18, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1890
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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 Story

Health-e-Connect System with IDA is a web-based software platform for remote monitoring of patient blood glucose data. Inputs include historical glucose test results uploaded from patient blood glucose meters. The IDA module processes these inputs using AACE and ADA clinical guidelines to calculate two reference insulin doses. If trends deviate from guidelines, the system flags a discrepancy between current and reference doses and alerts the managing healthcare provider. Used in home and clinical settings; operated by patients (data upload) and physicians/caregivers (review). Output is presented to the physician to assist in clinical decision-making regarding insulin dose adjustments. Benefits include improved diabetes management through data-driven review and standardized dosing references.

Clinical Evidence

No clinical data provided. Evidence consists of software verification and validation testing, and a human factors/usability study conducted with healthcare professionals in accordance with FDA guidance.

Technological Characteristics

Web-based software; no physical, electrical, or biocompatible materials. Connectivity via internet for data transmission from blood glucose meters. Software-only device; Major Level of Concern. Operates as a predictive value calculator for insulin dosing based on AACE and ADA guidelines.

Indications for Use

Indicated for adults with Type 2 diabetes on a fixed-dose insulin regimen, excluding insulin pump users, under the supervision of a healthcare provider trained in diabetes management.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

Dimensional Dosing Systems My Insulin Doser/IDS (K082512)
Dimensional Dosing Systems TrxF Intelligent Dosing Systems (IDS) (K011571)
ALR Health-e-Connect (K102063)

Related Devices

K082512 — INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER · Dimensional Dosing Systems, Inc. · Nov 7, 2008
K202596 — Insulia Diabetes Management Companion · Voluntis Sa. · Jun 4, 2021
K083263 — SYMCARE DIABETES MANAGEMENT PROGRAM · Symcare Personalized Health Solutions, Inc. · Mar 13, 2009
K193654 — BlueStar Rx · Welldoc, Inc. · Apr 7, 2020
K221924 — Digital Routines · Gnc Holdings, LLC · Mar 15, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 calculator NDC - 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 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: - 1. A data management tool and - 2. 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. {4}------------------------------------------------ #### Indications for Use: 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. #### 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 Dosing Systems My Insulin Doser / IDS K082512 | Dimensional Dosing Systems TRxF Intelligent Dosing Systems (IDS) K011571 | ALR Technologies Health-e- Connect K102063 | ALR Technologies Health-e- Connect with IDA | | Classification | NDC Dose calculator CFR 868.1890 | NDC Dose calculator CFR 868.1890 | NWB / JQP Glucose test system CFR 862.1345 | NDC Dose calculator CFR 868.1890 | | Intended use | Dose calculator Insulin | Dose calculator Insulin | Glucose test system | Dose calculator Insulin | | Indications for Use | My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target. | The Intelligent Dosing System (IDS) is a three- part software suite comprised of DoseRx, InterchangeRx and PracticePrescribeRx. The DQseRx is designed for use by trained clinicians to calculate any individual patient's optimal next dose for any given agent. The InterchangeRxis designed to switch a patient from one brand of agent to another while maintaining the | 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 or historical glucose test results and associated usage data in support of an effective diabetes management program. | 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 | | | | therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator that offers graded prescriber training of next dose calculation scenarios with scalable patient response and surrogate marker inputs that allows the healthcare provider to gain guided and measured experience in calculating the next dose for a new or infrequently used drug. The IDS is not a substitute for clinical reasoning. The IDS is an aid for trained clinicians based upon significant and properly entered data. 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. | | 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. | | Target Population | Diabetic patients | Healthcare professionals | Healthcare Professional Diabetics | Healthcare Professional Adult Type 2 diabetics | | Environment of use | Home | Healthcare facility | Clinical environments Home | Clinical environme nts Home | | Prescription use | Yes | Yes | No | Yes | | Technology | Software Major Level of Concern | Software Major Level of Concern | Software Moderate Level of Concern | Software Major Level of Concern | | Data Sources | Blood glucose meter Keyboard entry | Blood glucose meter Keyboard entry | Blood glucose meter Keyboard entry | Blood glucose meter Keyboard entry | | Data type | Real-time | Real-time Historical | Historical | Historical | | Dose adjustments | Patient receives best next dose data | Calculated and controlled by the doctor | No dosing | Dose adjustment presented to doctor for investigation then prescription changed and communicated with the patient | | | | | | patient by the doctor | | Basis of adjustment | No information | No information | N/A | Guidelines from AACE and ADA are used on the user's A1c and glucose values to form an adjustment recommendation | | Connectivity | Computer to computer via internet | Computer to computer via internet | Blood Glucose meter to computer Computer to computer via internet | Blood Glucose meter to computer Computer to computer via internet | | Data seen by | Healthcare provider | Healthcare provider | Healthcare provider Various representations of historical blood glucose values and statistics ALRT Staff Email and SMS message to patient | Healthcare provider Various representations of historical blood glucose values and statistics IDA utilizes AACE and ADA guidelines to alert managing clinician regarding dosing, sending alerts ALRT Staff Email and SMS message to patient | | Perform ance Testing | Performance testing performed and all tests showed satisfactory results | Performance testing performed and all tests showed satisfactory results | Software Verification and Validation | Software Verification and Validation | | Human Factors / Usability | Label comprehension | Not known | Lay user and Healthcare providers | Healthcare provides for IDA feature Lay users do not see IDA feature | {5}------------------------------------------------ {6}------------------------------------------------ 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 {7}------------------------------------------------ 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.