HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE

K141862 · H2, Inc. · NBW · Dec 2, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141862
• Device Name: HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
• Applicant: H2, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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.

Device Story

Device consists of Health2Sync Mobile Application and Smart Cable; enables transfer of blood glucose readings from compatible FDA-cleared meters to iPhone. User connects meter to smartphone via Smart Cable; app imports, stores, and displays glucose data. Features include lifestyle diary, graphs, data sharing with partners/providers, and report emailing. Used in home or professional settings by patients or healthcare providers. Output provides visual analysis of glucose trends over 14, 30, 60, or 90-day periods to support diabetes management. Does not provide treatment decisions or replace professional advice.

Clinical Evidence

No clinical trials performed. Bench testing included a usability study with 21 lay users to verify software ease of use and label comprehension. 100% of participants were satisfied/very satisfied. Data transmission accuracy was 100% across compatible meters. Meter memory rollover performance verified. Flesch-Kincaid readability score of 7.9 for user manual. Electromagnetic compatibility testing performed and compliant.

Technological Characteristics

System comprises mobile software and a physical Smart Cable with 3.5mm connector. Connectivity via audio port to iPhone. Data storage via Amazon Web Services. Software platform: iOS 7. Sterilization: N/A. Energy source: Powered by smartphone via audio port. No specific ASTM material standards cited.

Indications for Use

Indicated for people with diabetes and their healthcare professionals to review, analyze, and evaluate glucose test results to support diabetes management programs. Intended for home and professional use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Glooko Device System for Glooko Logbook+ Application (K130886)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K141862

B. Purpose for Submission:
New device

C. Manufacturer and Instrument Name:
H2 Inc.
Health2Sync Mobile Application

D. Type of Test or Tests performed:
Diabetes data management system

E. System Descriptions:

1. Device Description:
The Health2Sync Mobile Application and Smart Cable (Mobile Application and adapters) allow the transfer of blood glucose readings (data) from a compatible glucose meter to a smartphone via the Smart Cable. The Application 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.

2. Principles of Operation:
The Health2Sync Mobile Applications is a data management tool. The Health2Sync mobile application and smart cable are accessories to compatible blood glucose meters.

The HEALTH2SYNC software application will operate in the following operating environment: (Minimum Requirements)
- iOS Operating System (version 7.0)
- Language: English
- System Device: Apple iPhone 4/4S/5/5S,
- Input – Smart Cable connected to Blood Glucose Meter and the iOS Device audio port.

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3. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer webserver, or mobile device? Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission: Yes ☐ or No ☐ X

4. Specimen Identification:

Specimen Identification is based on time and date of testing.

5. Specimen Sampling and Handling:

Not applicable. There is no specimen handling in this device; the device transfers data only.

6. Calibration:

Glucose meter specific. See statement below under section J.

7. Quality Control:

Glucose meter specific. See statement below under section J.

8. Software:

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:

Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:

21 CFR §862.2100

21 CFR §862.1345

2. Classification:

Class I *

Class II

* A premarket notification (510 (k)) is required for Class I devices meeting the limitations under 21CFR 862.9 (c)(5) For use in diabetes management.

3. Product code:

JQP: Calculator/ Data Processing Module for Clinical Use

NBW: Blood Glucose Test System, Over-the-Counter

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4. Panel:
Clinical Chemistry (75)

G. Intended Use:

1. Indication(s) 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.

2. Special conditions for use statement(s):

Over-the-counter use.

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:

Glooko Device System for Glooko Logbook+ Application (K130886)

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2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Health2Sync Mobile Application and Smart Cable (K141862) | Glooko Device System for Glooko Logbook+ Application (K130886) |
| Intended Use | For use by patients with diabetes to sync blood glucose data from compatible meters to mobile Application installed on compatible iOS device(s) | Same |
| Syncs with Compatible Meters | Yes | Same |
| Multiple Patients Use | Yes - Multiple patients may use the same device by signing in with unique user ID and password | Same |
| Data List | List all readings in “Diary” | Same |
| Daily Activities Records | Yes | Same |
| Average Data Display | Yes | Same |
| Change Meter Settings | Does not allow changes to meter settings | Same |
| Password | Password protection on the Application | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Health2Sync Mobile Application and Smart Cable (K141862) | Glooko Device System for Glooko Logbook+ Application (K130886) |
| Operation System (minimum requirement) | iOS 7.0 | iOS 5.0 |
| Compatible Blood Glucose Meters | • OMNIS Health Embrace BGMS Meter
• OMNIS Health Embrace EVO BGMS Meter
• Medline EvenCare G2 BGMS meter | • Abbott: FreeStyle Freedom Lite®, FreeStyle Lite®
• ARKRAY: GLUCOCARD® 01, GLUCOCARD® VitalTM
• Bayer: Bayer’s BREEZE®2, Bayer’s CONTOUR®, Bayer’s CONTOUR® NEXT EZ.
• iSens: CareSens N and CareSens N POP
• LifeScan: OneTouch® Ultra®2, OneTouch® UltraLink®, OneTouch® UltraMini®
• ReliOn: ReliOn® Confirm, ReliOn® Prime
• Roche: ACCU-CHEK® Aviva, ACCU-CHEK® Compact Plus, ACCU-CHEK® Nano |
| Connectivity to meter | Audio Port, via Smart Cable | 30-pin or lightning 8-pin connector (requires Apple’s off-the-shelf Lightning to 30-pin adapter for connection), via MeterSync Cable |
| Hardware Platform | iPhone 4, 4S, 5 and 5S | • iPod touch: 3 and 4G
• iPhone: 3GS, 4 and 4S
• iPad: iPad 1, 2 and iPad 3G
• iPod touch 5G, iPhone 5, iPad mini, and iPad 4G |
| 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 |
| Invite Others to View Data through Authorization | Yes (through Partners / Invitations feature) | No |

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# I. Standard/Guidance Document Referenced (if applicable):

ISO 14971:2007 – Medical Devices – Application of risk management of medical devices

EN 61000-3-3:2008 – Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection

EN 55022:2010 – Information technology equipment. Radio disturbance characteristics. Limits and methods of measurement.

EN 55024:2010 – Information technology equipment. Immunity characteristics. Limits and methods of measurement.

# J. Performance Characteristics:

1. Analytical Performance:

The performance characteristics listed below as applicable, were established in the specific glucose meter clearance under K113098, K090043, and K113208.

a) Accuracy:
See above statement under section J(1).

b) Precision/Reproducibility:
See above statement under section J(1).

c) Linearity:
See above statement under section J(1).

d) Carryover:
See above statement under section J(1).

e) Interfering Substances:
See above statement under section J(1).

2. Other Supportive Instrument Performance Data Not Covered Above:

1. A usability study was performed with 21 lay users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. Study participants also completed a questionnaire in response to whether the software, smart cable, and labeling are easy to use. The sponsor concluded that 100% of users were either satisfied or very satisfied with the software, cable, and user manual. The protocol and acceptance criteria of the usability studies were reviewed and found to be acceptable. During this study, data transmission accuracy of the devices was tested, with lay users transmitting data from blood glucose meters to the software. 100% of data was accurately transmitted. Meter memory rollover performance was also verified to be correct on each of the three compatible meters. The results from the usability study demonstrated that the

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product performs as intended in the hands of lay users and healthcare professionals. All test results fell within the pre-determined specification parameters.

2. The following documentation related to the software was reviewed and found to be acceptable: level of concern (Moderate), software requirements specifications, architecture design chart, software design specification, traceability analysis, software development environment description, verification and validation testing, device hazard analysis. The sponsor reports that no unresolved anomalies are known to exist in the release version of the software.

3. The results of a Flesch-Kincaid readability assessment were provided, indicating a Grade Level Score of 7.9 for the Health2Sync Application User Manual.

4. The sponsor provided the appropriate documentation certifying that electromagnetic testing had been evaluated and found to be compliant.

K. Proposed Labeling:
The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.