(265 days)
Not Found
No
The description explicitly states that the IDA feature employs "AACE and ADA algorithms" to calculate reference doses, which are established clinical guidelines, not AI/ML models. There is no mention of AI, ML, or training/test data sets typically associated with such technologies.
No.
Explanation: The device is a software system intended to aid in the review, analysis, and evaluation of historical glucose test results and associated usage data to support diabetes management. While it assists healthcare providers in making adjustments to a patient's care plan by providing reference doses and flagging potential dose adjustments based on blood glucose trends, it explicitly states that "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." This indicates it is a decision support tool, not a device that directly administers therapy or performs a therapeutic function.
Yes
The device aids in the review, analysis, and evaluation of historical glucose test results to support diabetes management and helps healthcare providers make adjustments to a patient's care plan based on blood glucose trends, including suggesting potential insulin dose adjustments.
Yes
The device description explicitly states, "There are no physical, electrical, biocompatible, or sterility specifications for this device as it is software only." The modification also describes the addition of a "module of software."
Based on the provided information, the Health-e-Connect System with IDA is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Health-e-Connect System with IDA primarily uses blood glucose values uploaded from a blood glucose meter. While blood glucose is a biological measurement, the system itself is not performing the in vitro test on a specimen. The blood glucose meter is the device that performs the in vitro diagnostic test.
- The system's intended use is for review, analysis, and evaluation of historical glucose test results and associated usage data. It's a data management and analysis tool, not a device that directly performs a diagnostic test on a biological sample.
- The IDA feature provides reference doses based on algorithms and flags potential inconsistencies. It's an aid for healthcare providers in making decisions, not a device that provides a diagnostic result from a specimen.
The system relies on the results of an IVD (the blood glucose meter) but is not an IVD itself. It falls more under the category of a medical device software that aids in the management of a condition based on data from other devices.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
NDC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Intended for use in the home and clinical settings by people with diabetes and healthcare providers.
The Health-e-Connect System with IDA is for patients under the supervision of a physician / healthcare provider trained in the management of diabetes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
-
- 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.
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.