(145 days)
Not Found
No
The document describes a data management application and cable for transferring blood glucose data. There is no mention of AI, ML, or any analytical capabilities beyond basic data viewing and analysis of glucose readings within different time slots. The performance studies focus on data transmission, user performance, and regulatory compliance, not on algorithmic performance.
No
The device is described as "data management software" intended to "aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program." It explicitly states, "Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice," indicating it does not directly treat or prevent a disease.
No
The Health2Sync Mobile Application is data management software that aids in the review, analysis, and evaluation of glucose test results. It explicitly states that it is "not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice," indicating it does not diagnose conditions.
No
The device description explicitly states that the system includes both the Health2Sync Mobile Application (software) and the Smart Cable (hardware).
Based on the provided information, the Health2Sync Mobile Application and Smart Cable is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program." It explicitly states it is "not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice." This indicates it's a data management and analysis tool, not a device that performs a diagnostic test on a biological sample.
- Device Description: The device description focuses on the transfer and display of blood glucose readings from compatible meters. It doesn't describe any components or processes that would perform a diagnostic test.
- Lack of Diagnostic Function: The system's function is to receive and present data from existing, FDA-cleared blood glucose meters (which are IVDs). The Health2Sync system itself does not perform the blood glucose measurement or analysis on a biological sample.
In summary, the Health2Sync system acts as a data management and visualization tool for data generated by IVD devices (the compatible blood glucose meters). It does not perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform.
Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JOP
Device Description
The Health2Sync Mobile Application and Smart Cable (Mobile App and adapters) allows the transfer of blood glucose readings from the compatible glucose meter to smartphone via Smart Cable.
The App features enable the user to view and analyze blood glucose readings from different meal time periods, other features including lifestyle diary, interpretable graphs option, inviting and sharing data with partners, and emailing reports are available for viewing and analyzing blood glucose readings within the different time slots.
The system includes: 1) Health2Sync Mobile Application (through Apple store only), 2) Smart Cable, 3) Smart Cable 3.5mm connector (optional) and 4) Smart Cable and Application Quick Start Guide
Compatible Meters include: OMNIS Health Embrace BGMS Meter, (K113098) OMNIS Health Embrace EVO BGMS Meter (K090043), and Medline EvenCare G2 BGMS meter (K113208)
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
home and professional settings
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
Description of the test set: Software test used 2 meters per model, 6 meters in 3 models with fully loaded data; and 15 meters in 3 models with partially loaded data.
Sample size: 2 meters per model, 6 meters in 3 models with fully loaded data; and 15 meters in 3 models with partially loaded data.
Data source: compatible blood glucose meters (OMNIS Health Embrace BGMS Meter, OMNIS Health Embrace EVO BGMS Meter, Medline EvenCare G2 BGMS meter)
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Data Transmission Memory Rollover Synchronization Verification
Sample Size: 2 meters per model, 6 meters in 3 models with fully loaded data; and 15 meters in 3 models with partially loaded data.
Key Results:
- OMNIS Health Embrace BGMS Meter: Full set of data (300 records) transferred from meter to Mobile App was accurately downloaded (Pass). Meter memory data rollover accurately transmitted to Mobile App with additional new data (Pass).
- OMNIS Health Embrace EVO BGMS Meter: Full set of data (300 records) transferred from meter to Mobile App was accurately downloaded (Pass). Meter memory data rollover accurately transmitted to Mobile App with additional new data (Pass).
- Medline EvenCare G2 BGMS meter: Full set of data (300 records) transferred from meter to Mobile App was accurately downloaded (Pass). Meter memory data rollover accurately transmitted to Mobile App with additional new data (Pass).
Study Type: User Performance Evaluation
Sample Size: 21 participants
Key Results: The study demonstrates that English-speaking laypersons are able to follow user instructions to successfully download Health2Sync Mobile Application, connect Smart Cable with compatible meter to smartphone and import data to Health2Sync Mobile Application for diabetes management.
Study Type: Electromagnetic Compatibility (EMC)
Sample Size: Not Applicable
Key Results: The EMC reports confirmed that Smart Cable met performance criteria indicated by the standards.
Study Type: Readability Assessment
Sample Size: Not Applicable
Key Results: The obtained results demonstrate that Smart Cable Quick Start guide and Mobile App User Manual each received a Flesch-Kincaid Grade Level that indicates each text is expected to be understood by an average student in the eighth grade. The assessments ranged from 7.7 to 7.9 and therefore each text meets the criteria.
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
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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right.
December 2, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
H2 INC. C/O FENG-YU LEE PRINCIPAL CONSULTANT 29222 RANCHO VIEJO RD, STE 218 SAN JUAN CAPISTRANO CA 92675
Re: K141862
Trade/Device Name: Health2Sync Mobile Application and Smart Cable Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: October 13, 2014 Received: October 15, 2014
Dear Ms. Feng-Yu Lee:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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/Resourcesfor You/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 yours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Health2Sync Mobile Application and Smart Cable For Diabetes Management
Indications for Use (Describe)
Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform.
Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
3
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4
Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K141862
1. Submitter's Identification:
H2 Inc. 5 Fl., No. 586, Ruiguang Rd., Taipei City 114, Taiwan (R.O.C.) Contact Person: Chu-Yie Deng Phone Number: 886-2-8797-3844 FAX Number: 886-2-8797-3923
Date Summary Prepared: November 26, 2014
2. Contact Persons:
Primary Contact: Mrs. Feng-Yu Lee Correspondent for this Application H2 Inc. c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano Tel: (949) 218-0929 Fax: (949) 218-0928 fengyulee@ivddreg.com
Alternate Only: Erin Chung H2 Inc. 5 Fl., No. 586, Ruiguang Rd., Taipei City 114, Taiwan (R.O.C.) Contact Person: Chu-Yie Deng Phone Number: 886-2-8797-3844 FAX Number: 886-2-8797-3923
3. Name of the Device:
Health2Sync Mobile Application and Smart Cable for Diabetes Management
5
4. Device Common or Usual Name:
Diabetes Monitoring (Blood Glucose Meter) and Data Management System (Software and adapters)
Regulation Info:
| Device Name | Product Code | Classification | Regulation | Panel |
|---|---|---|---|---|
| Glucose Test | ||||
| System | NBW: Blood | |||
| Glucose Test | ||||
| System, Over-the- | ||||
| Counter | Class II | 21 CFR § | ||
| 862.1345 | Clinical | |||
| Chemistry | ||||
| (75) | ||||
| Calculator/Data | ||||
| Processing | ||||
| Module for | ||||
| Clinical Use | JQP: Calculator/ | |||
| Data Processing | ||||
| Module for Clinical | ||||
| Use | Class I | 21 CFR § | ||
| 862.2100 | Clinical | |||
| Chemistry | ||||
| (75) |
4. Device Description:
The Health2Sync Mobile Application and Smart Cable (Mobile App and adapters) allows the transfer of blood glucose readings from the compatible glucose meter to smartphone via Smart Cable.
The App features enable the user to view and analyze blood glucose readings from different meal time periods, other features including lifestyle diary, interpretable graphs option, inviting and sharing data with partners, and emailing reports are available for viewing and analyzing blood glucose readings within the different time slots.
The system includes: 1) Health2Sync Mobile Application (through Apple store only), 2) Smart Cable, 3) Smart Cable 3.5mm connector (optional) and 4) Smart Cable and Application Quick Start Guide
Compatible Meters include: OMNIS Health Embrace BGMS Meter, (K113098) OMNIS Health Embrace EVO BGMS Meter (K090043), and Medline EvenCare G2 BGMS meter (K113208)
-
- Intended Use:
Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform.
- Intended Use:
6
Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.
-
- Predicate Device Information:
The Health2Sync Mobile Application and Smart Cable is substantially equivalent to the predicate device noted below.
- Predicate Device Information:
Glooko Device System for Glooko Logbook+ Application Name: Device Company: Glooko, Inc. 510(K) Number: K130886
7. Specification Comparison to Predicate Devices:
| Similarities and Differences | ||||
|---|---|---|---|---|
| Item | Health2Sync | |||
| (Candidate Device) | Glooko Device System for | |||
| Glooko Logbook+ Application | ||||
| (K130886) | ||||
| Intended Use / | ||||
| Indication(s) for | ||||
| Use | • For use by patients with diabetes | |||
| to sync blood glucose data from | ||||
| compatible meters to mobile App | ||||
| installed on compatible iOS | ||||
| device(s) | ||||
| • Allow users to share data by | ||||
| emailing the report or inviting | ||||
| other personnel, including but not | ||||
| limited to healthcare provider to | ||||
| view the data | ||||
| • When mobile App is installed on | ||||
| a smartphone, a database can be | ||||
| used to store users' profiles and | ||||
| manage their blood glucose | ||||
| readings. | ||||
| • User needs to log in with unique | ||||
| user ID and password to view and | ||||
| organize blood glucose readings. | • For use by patients with diabetes to | |||
| sync blood glucose data from | ||||
| compatible meters to mobile App | ||||
| installed on compatible iOS device(s) | ||||
| • Allow users to share data by emailing | ||||
| the report | ||||
| • When mobile App is installed on a | ||||
| smartphone, a database can be used to | ||||
| store users' profiles and manage their | ||||
| blood glucose readings | ||||
| • User needs to log in with unique user | ||||
| ID and password to view and organize | ||||
| blood glucose readings. | ||||
| Operation System | iOS 7 | iOS 5.0 and higher | ||
| Syncs with | ||||
| Compatible Meters | Yes | Yes |
7
| Compatible Blood
Glucose Meters | • OMNIS Health Embrace BGMS
Meter (Up to 300 data stored),
• OMNIS Health Embrace EVO
BGMS Meter (Up to 300 data
stored), and
• Medline EvenCare G2 BGMS
meter (Up to 300 data stored) | Other BGMS meters |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection | Audio Port | 30-pin or lightning 8-pin connector
(require Apple's off-the-shelf
Lightning to 30-pin adapter for
connection) |
| COM Ports Scan | None Applicable | None Applicable |
| Hardware 1 | Smart cable | MeterSync Cable
IR Adapter |
| Hardware 2 | iPhone 4, 4S, 5 and 5S | • iPod touch: 3 and 4G
• iPhone: 3GS, 4 and 4S
• iPad: iPad 1, 2 and iPad 3G
(Accessed in 2X mode)
• iPod touch 5G, iPhone 5, iPad
mini, and iPad 4G (require
Apple's off-the-shelf Lightning
to 30-pin adapter for
connection) |
| Multiple Patients
Use | Yes
(Allow multiple patients to use the
same Smart Cable and Application,
but with different user IDs) | Same |
| Data List | List all reading in "Diary" | Same |
| Target Levels | High and low blood glucose target
levels can be changed: Before Meal,
After Meal, Bed Time | High and low blood glucose target
levels can be changed: Before Meal,
After Meal |
| Daily Activities
Records | Yes | Yes |
| Transferred Data
Time Periods | 14, 30, 60, and 90 day time periods
for displaying the transfer blood
glucose levels cannot be changed | Same |
| Data Base | Can Set up multiple patient data bases | Same |
| Average Data
Display | Yes | Yes |
| Invite Others to
View Data through
Authorization | Yes (through invitation feature) | No |
| Data Reports and
Charts | Data List, statistics, Pie Chart, Line
graph by time of the day and by date
for the selected time periods (14 days,
30 days, 60 days, 90 days). | Data List, statistics, Pie Chart, Line
graph by time of the day and by date
for the selected time periods (two
weeks, 1 month) |
| Change Meter
Settings | Does not allow change to meter
settings | Same |
H2 Inc.
8
| Password | Password protection on the App | Same |
|---|---|---|
| Database Providers | Amazon Web Service | Unknown |
| Associate a Meter to Specific Personal Account | No association | No association |
-
- Discussion of Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Verification and validation of test results were evaluated to establish the performance, functionality and reliability of the Rightest Diabetes Management System, and the GE Diabetes Management System.
- Discussion of Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Data Transmission Memory Rollover Synchronization Verification
Data transmission accuracy and memory data rollover synchronization were tested at each compatible meter's full data memory capacity to ensure successful upload and storage into software database of the Health2Sync Mobile App Management System. Software test used 2 meters per model, 6 meters in 3 models with fully loaded data; and 15 meters in 3 models with partially loaded data.
| Meter | Expected Test Result | Result |
|---|---|---|
| OMNIS Health | ||
| Embrace BGMS Meter | Full set of data (300 records) transferred | |
| from meter to Mobile App was accurately | ||
| downloaded | Pass | |
| Meter memory data rollover accurately | ||
| transmitted to Mobile App with additional | ||
| new data | Pass | |
| OMNIS Health | ||
| Embrace EVO BGMS | ||
| Meter | Full set of data (300 records) transferred | |
| from meter to Mobile App was accurately | ||
| downloaded | Pass | |
| Meter memory data rollover accurately | ||
| transmitted to Mobile App with additional | ||
| new data | Pass | |
| Medline EvenCare G2 | ||
| BGMS meter | Full set of data (300 records) transferred | |
| from meter to Mobile App was accurately | ||
| downloaded | Pass | |
| Meter memory data rollover accurately | ||
| transmitted to Mobile App with additional | ||
| new data | Pass |
9
Discussion of Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence (Cont.):
User Performance Evaluation:
The User (Layperson) Performance Evaluation of Health2Sync Mobile Application and Smart Cable study included 21 participants of varying age, sex, background, education level, and work experience.
The study demonstrates that English-speaking laypersons are able to follow user instructions to successfully download Health2Sync Mobile Application, connect Smart Cable with compatible meter to smartphone and import data to Health2Sync Mobile Application for diabetes management.
Electromagnetic Compatibility (EMC):
To evaluate the compliance of safety requirements for electrical equipment - Smart Cable, the certificate testing and compliance reports were performed by Compliance Certification Services Inc. Taiwan Wugu Laboratory.
The EMC reports confirmed that Smart Cable met performance criteria indicated by the standards.
Readability Assessment:
The Readability Assessment Tests were performed using the Flesch-Kincaid Grade Level Score to evaluate the readability of the Smart Cable Quick Start guide and Mobile App User Manual.
The obtained results demonstrate that Smart Cable Ouick Start guide and Mobile App User Manual each received a Flesch-Kincaid Grade Level that indicates each text is expected to be understood by an average student in the eighth grade. The assessments ranged from 7.7 to 7.9 and therefore each text meets the criteria.
9. Conclusion:
Results of performance evaluation of the Health2Sync Mobile App and Smart Cable with compatible blood glucose meters demonstrate that the subject devices are substantially equivalent to the predicate devices.