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.

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)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Health2Sync Mobile Application and Smart Cable for Diabetes Management
Intended Use: Data management software for home and professional settings to aid people with diabetes and healthcare professionals in reviewing, analyzing, and evaluating glucose test results to support diabetes management. The Smart Cable allows uploading blood glucose data from compatible FDA-cleared meters to the Health2Sync Mobile Application on iPhone. It is not intended to provide treatment decisions or substitute professional healthcare advice.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating functional equivalence and safety rather than specific numerical acceptance criteria for a diagnostic performance. Acceptance is generally implied by successfully passing various verification tests.

Acceptance Criteria (Implied / Explicit)	Reported Device Performance
Data Transmission Accuracy & Memory Rollover Synchronization	Full set of data (300 records) from each compatible meter (OMNIS Health Embrace BGMS, OMNIS Health Embrace EVO BGMS, Medline EvenCare G2 BGMS) was accurately downloaded to the Mobile App. Meter memory data rollover was accurately transmitted to Mobile App with additional new data.
User (Layperson) Performance (Ability to use the device as intended)	21 participants, varying in age, sex, background, and education level, were able to successfully follow user instructions to download the app, connect the Smart Cable with a compatible meter to a smartphone, and import data for diabetes management.
Electromagnetic Compatibility (EMC)	EMC reports confirmed that the Smart Cable met performance criteria indicated by the standards.
Readability of User Manuals (Smart Cable Quick Start guide & Mobile App User Manual)	Both documents received a Flesch-Kincaid Grade Level score between 7.7 and 7.9, indicating they meet the criteria of being understandable by an average student in the eighth grade.

2. Sample Size Used for the Test Set and Data Provenance

Data Transmission Memory Rollover Synchronization Verification:
- Test Set Sample Size: 2 meters per model (total 6 meters) with fully loaded data, and 15 meters across 3 models with partially loaded data.
- Data Provenance: Not explicitly stated, but implied to be laboratory-generated or controlled data for testing purposes within the manufacturer's verification process. No mention of country of origin or retrospective/prospective human data.
User Performance Evaluation:
- Test Set Sample Size: 21 participants.
- Data Provenance: Not explicitly stated, but implied to be a prospective user study conducted by the manufacturer for evaluation. No mention of country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is generally not applicable for this device. The device's primary function is data transfer and display, not a diagnostic interpretation that requires expert ground truth.

For the Data Transmission testing, the "ground truth" is the data stored on the blood glucose meters themselves, and the accuracy is verified against this known data. No human experts are involved in establishing this ground truth.
For the User Performance Evaluation, the "ground truth" is the successful completion of tasks as defined by the study protocol. No external experts are required to establish this.
For EMC and Readability, the ground truth is established by standardized testing protocols and algorithms (e.g., Flesch-Kincaid Grade Level), not human experts.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests focus on functional verification, user task completion, and adherence to technical standards rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing AI-assisted performance against unaided human performance. The device is a data management tool, not an AI diagnostic aid in the traditional sense that would warrant an MRMC study.

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

Yes, the described verification tests for "Data Transmission Memory Rollover Synchronization" and "Electromagnetic Compatibility (EMC)" represent standalone performance evaluations of specific device components (Smart Cable, Mobile App's data handling). The "Readability Assessment" is also a standalone evaluation of the documentation.

The "User Performance Evaluation" implicitly involves a human-in-the-loop, but the overall assessment of the device's core data management functions (e.g., accurate data transfer) is conducted in a standalone manner against predefined criteria.

7. The Type of Ground Truth Used

Data Transmission Memory Rollover Synchronization Verification: The ground truth was the known data stored on the compatible blood glucose meters. The transferred data was compared against this known source for accuracy.
User Performance Evaluation: The ground truth was the successful completion of predefined user tasks according to the device's instructions for use.
Electromagnetic Compatibility (EMC): The ground truth was established by international and national safety standards for electrical equipment.
Readability Assessment: The ground truth was established by the Flesch-Kincaid Grade Level algorithm, a standardized metric for readability.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The Health2Sync Mobile Application appears to be a data management software that processes and displays glucose readings rather than learning patterns from a training dataset. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a training set or an AI/machine learning component that requires one, this information is not applicable.

Summary

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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.

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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

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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 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

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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

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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 TestSystem	NBW: BloodGlucose TestSystem, Over-the-Counter	Class II	21 CFR §862.1345	ClinicalChemistry(75)
Calculator/DataProcessingModule forClinical Use	JQP: Calculator/Data ProcessingModule for ClinicalUse	Class I	21 CFR §862.2100	ClinicalChemistry(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 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)

1. 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.

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Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.

1. Predicate Device Information:
  The Health2Sync Mobile Application and Smart Cable is substantially equivalent to the predicate device noted below.

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 forGlooko Logbook+ Application(K130886)
Intended Use /Indication(s) forUse	• For use by patients with diabetesto sync blood glucose data fromcompatible meters to mobile Appinstalled on compatible iOSdevice(s)• Allow users to share data byemailing the report or invitingother personnel, including but notlimited to healthcare provider toview the data• When mobile App is installed ona smartphone, a database can beused to store users' profiles andmanage their blood glucosereadings.• User needs to log in with uniqueuser ID and password to view andorganize blood glucose readings.	• For use by patients with diabetes tosync blood glucose data fromcompatible meters to mobile Appinstalled on compatible iOS device(s)• Allow users to share data by emailingthe report• When mobile App is installed on asmartphone, a database can be used tostore users' profiles and manage theirblood glucose readings• User needs to log in with unique userID and password to view and organizeblood glucose readings.
Operation System	iOS 7	iOS 5.0 and higher
Syncs withCompatible Meters	Yes	Yes

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Compatible BloodGlucose Meters	• OMNIS Health Embrace BGMSMeter (Up to 300 data stored),• OMNIS Health Embrace EVOBGMS Meter (Up to 300 datastored), and• Medline EvenCare G2 BGMSmeter (Up to 300 data stored)	Other BGMS meters
Connection	Audio Port	30-pin or lightning 8-pin connector(require Apple's off-the-shelfLightning to 30-pin adapter forconnection)
COM Ports Scan	None Applicable	None Applicable
Hardware 1	Smart cable	MeterSync CableIR 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, iPadmini, and iPad 4G (requireApple's off-the-shelf Lightningto 30-pin adapter forconnection)
Multiple PatientsUse	Yes(Allow multiple patients to use thesame 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 targetlevels can be changed: Before Meal,After Meal, Bed Time	High and low blood glucose targetlevels can be changed: Before Meal,After Meal
Daily ActivitiesRecords	Yes	Yes
Transferred DataTime Periods	14, 30, 60, and 90 day time periodsfor displaying the transfer bloodglucose levels cannot be changed	Same
Data Base	Can Set up multiple patient data bases	Same
Average DataDisplay	Yes	Yes
Invite Others toView Data throughAuthorization	Yes (through invitation feature)	No
Data Reports andCharts	Data List, statistics, Pie Chart, Linegraph by time of the day and by datefor the selected time periods (14 days,30 days, 60 days, 90 days).	Data List, statistics, Pie Chart, Linegraph by time of the day and by datefor the selected time periods (twoweeks, 1 month)
Change MeterSettings	Does not allow change to metersettings	Same

H2 Inc.

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Password	Password protection on the App	Same
Database Providers	Amazon Web Service	Unknown
Associate a Meter to Specific Personal Account	No association	No association

1. 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.

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 HealthEmbrace BGMS Meter	Full set of data (300 records) transferredfrom meter to Mobile App was accuratelydownloaded	Pass
	Meter memory data rollover accuratelytransmitted to Mobile App with additionalnew data	Pass
OMNIS HealthEmbrace EVO BGMSMeter	Full set of data (300 records) transferredfrom meter to Mobile App was accuratelydownloaded	Pass
	Meter memory data rollover accuratelytransmitted to Mobile App with additionalnew data	Pass
Medline EvenCare G2BGMS meter	Full set of data (300 records) transferredfrom meter to Mobile App was accuratelydownloaded	Pass
	Meter memory data rollover accuratelytransmitted to Mobile App with additionalnew data	Pass

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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.

Regulation Number and Section

§ 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.