(445 days)
Not Found
No
The description focuses on data management, communication, and display of historical glucose data. There is no mention of AI or ML algorithms for analysis, prediction, or interpretation of the data beyond simple range checking.
No
The device is described as a data management tool and communication platform for reviewing, analyzing, and evaluating historical glucose test results, rather than directly treating or diagnosing a condition.
No
This device is described as an internet-based blood glucose monitoring system that serves as a data management tool and communication platform for reviewing, analyzing, and evaluating historical glucose test results. It does not perform diagnostic functions itself but aids in the review of data from diagnostic devices (blood glucose meters). The clinical testing section also states, "Clinical testing was not performed to support this submission as the HeC is a data collection device only."
Yes
The device description explicitly states "Note there are no physical, electrical, biocompatibility or sterility specifications for this device as it is software only." and describes it as an internet-based system comprised of a home-based application and a server, relying on legally marketed peripherals (blood glucose meters) for data input.
Based on the provided information, the Health-e-Connect System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the review, analysis and evaluation of historical glucose test results and associated usage data in support of an effective diabetes management program." It is a data management and communication tool.
- Device Description: The description explicitly states it is "software only" and performs "two functions: it is a data management tool and a communication platform." It collects, stores, and displays data from legally marketed blood glucose meters (which are IVDs). It does not perform any diagnostic testing itself.
- Performance Studies: The performance studies focus on bench testing of the meters (which are peripherals, not the HeC system itself in terms of diagnostic function) and usability/human factors. There is no clinical testing performed to support a diagnostic claim.
- Key Metrics: There are no key metrics like sensitivity, specificity, PPV, or NPV mentioned, which are typical for IVD devices.
The Health-e-Connect System acts as a tool to manage and present data generated by IVD devices (blood glucose meters), but it does not perform the diagnostic test itself. It falls under the category of a data management system for medical devices.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
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.
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
Not Found
Intended User / Care Setting
Intended for use in the home and clinical settings by people with diabetes and healthcare providers.
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
Bench Testing
Test: View Glucometer summary of a user. Procedure: Correct Glucometer summary (checked against paper copy & calculations).
Test: Glucometer usage uploaded into the HEC. Procedure: Take a blood test and check blood-sugar value on glucometer. Connect glucometer to HeC Desktop Programmer and upload. Check HeC recorded value.
Test: Patient information and import data are not associated correctly. Procedure: Performed many uploads of the glucometer. For each upload, a log is created, manually checked the log for the uploads.
Test: Glucose analysis is flawed and the results are not correct in the HeC-RCS. Procedure: The code which analyzes the glucometers values is checked thoroughly against other algorithms calculating the same statistics to verify accuracy.
Glucose meter test summary:
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing: All listed meters passed the outlined tests (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).
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.
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
§ 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.
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OCT 1 1 2011
510(k) Summary Page 1 of 5 7-Oct-11
| Official Contact: | Lawrence Weinstein, President
ALR Technologies
3350 Riverwood Pkwy, Suite 1900
Atlanta GA, 30339 USA
Tel - 804-302-4905
Fax - 678-881-1418
e-mail: larryw@alrt.com |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Health-e-Connect System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification Name: | System, Test, Blood Glucose OTC
NBW - 862.1345, Class - 2
Calculator/Data Processing Module for Clinical Use
JQP - 862.2100, Class - 1 |
| Predicate Device: | K062770
Copilot Health Management System
Abbott Diabetes Care Inc.
K090801
Electronic House Call System
Express MD Solutions, LLC |
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.
1
1
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:
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.
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.
2
510(k) Summary Page 3 of 5 7-Oct-11
Bench Testing
| Test:
Procedure: | View Glucometer summary of a user
Correct Glucometer summary (checked against paper copy & calculations) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test:
Procedure: | Glucometer usage uploaded into the HEC
Take a blood test and check blood-sugar value on glucometer. Connect
glucometer to HeC Desktop Programmer and upload. Check HeC recorded
value. |
| Test:
Procedure: | Patient information and import data are not associated correctly
Performed many uploads of the glucometer. For each upload, a log is
created, manually checked the log for the uploads. |
| Test: | Glucose analysis is flawed and the results are not correct in the
HeC-RCS |
| Procedure: | The code which analyzes the glucometers values is checked thoroughly
against 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
3
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.
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.
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
4
510(k) Summary
.
| Attribute | Express MD Solutions, LLC
Electronic House Call System
510(k) K090801 | Abbott Diabetes Care
CoPilot
510(k) K062770 | ALR Technologies
Health-e-Connect
510(k) unknown | Discussion of Differences |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Indications for
Use | The Electronic House Call System (Electronic House Call
Device + Electronic House Call Application + Electronic
House Call Website) is a remote, retrospective monitoring
tool for supplement in a patients' care. The Electronic
House Call Device together with the Electronic House
Call Application is intended to be a simple "store and
forward" communications platform that allows clinicians
and privileged users to access a patients' information for
review through the Electronic House Call Website. The
Electronic House Call Device is a tool to monitor patients'
remotely and motivate them through education and
reminders. The Electronic House Call System allows
patients to measure vital signs without assistance from
their healthcare provider. The Electronic House Call
System is not intended to replace existing treatments or
consultations, nor is it to be used as a substitute for a
qualified healthcare professional's judgment/treatment
plan. The Electronic House Call System is also not
intended to act as an emergency response system. | The CoPilot Health Management System is
intended for use in the home and clinical settings
by people with diabetes and healthcare
professionals as an aid in the review, analysis and
evaluation of historical glucose test results in
support of an effective diabetes management
program. | 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. | Equivalent to K090801 and
K062770
Connects to blood glucose meter |
| Environments
of use | Home and clinical environments (not explicitly stated) | Home and clinical environments (not explicitly
stated) | 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 less
cumbersome, more reliable means
of communication |
| Output | Telephone line or other identified method (existing high-
speed connection in patient's home) | Computer to health care provider via printing
faxing or emailing | Computer to computer via internet | Health-e-Connect provides a less
cumbersome, more reliable means
of communication |
| Output | Email to clinician | Various representations of historical blood
glucose values and statistics. | Various representations of historical blood glucose
values and statistics.
Email or SMS message to patient | Similar to K062770 |
| Prescriptive | Yes | No | No | Same as K062770 |
5
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).
6
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
7
Indications for Use Statement
510(k) Number (if known): K102063
Device Name:
Health-e-Connect System
Indications for Use:
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.
| 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
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