MyGlucoHealth Wireless System

K143169 · Entra Health Systems · NBW · Jan 8, 2016 · Clinical Chemistry

Device Facts

• Record ID: K143169
• Device Name: MyGlucoHealth Wireless System
• Applicant: Entra Health Systems
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MyGlucoHealth Wireless System, is intended for single-patient use only.

Device Story

System consists of wireless glucose meter, control solutions, and test strips; used by diabetic patients at home for quantitative whole blood glucose monitoring. Input: capillary whole blood sample via biosensor test strip. Operation: glucose oxidase biosensor technology; embedded cellular module transmits data to MyHealthPoint TeleHealth Manager remote database. Output: blood glucose concentration displayed on LCD; data transmitted wirelessly to cloud repository. Healthcare provider accesses data via remote database to monitor patient glucose control. Benefits: facilitates remote monitoring and management of diabetes. Includes LED light for test strip insertion guidance. Single-patient use only.

Clinical Evidence

No clinical data. Bench testing only. Disinfection efficacy studies demonstrated complete inactivation of HBV using CaviWipes XL. Robustness studies confirmed no performance or material degradation after 156 cleaning/disinfection cycles, simulating 3 years of single-patient use.

Technological Characteristics

Glucose oxidase biosensor; quantitative measurement range 10-600 mg/dL; hematocrit 20-60%; sample volume 0.3 uL; test time 3 seconds. Connectivity: embedded cellular radio for remote database transmission. Power: rechargeable Lithium Ion battery. Display: LCD with LED strip insertion guide. Standards: ISO 15197:2003, ISO 14971:2012, IEC 61010-1:2001, IEC 61010-2-101:2002.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood.

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

• MyGlucoHealth Glucose Monitoring System (K081703)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ENTRA HEALTH SYSTEMS RICHA PADHY A RAQA COORDINATOR 3111 CAMINO DEL RIO NORTH SUITE 101 SAN DIEGO CA 92108

January 8, 2016

Re: K143169

Trade/Device Name: MyGlucoHealth Wireless System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: December 3, 2015 Received: December 11, 2015

Dear Richa Padhya:

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 (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.

{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 [phone] or [phone] 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 [phone] or [phone] 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}------------------------------------------------

## Indications for Use

510(k) Number (if known) K143169

Device Name MyGlucoHealth Wireless System

#### Indications for Use (Describe)

The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E," "h," and "S," separated by vertical lines. The "h" is inside a maroon circle. Below the letters is the text "Entra Health Systems" in a red serif font.

Date: September 1 2015

Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax [phone]

#### 510(k) Summary

| A. Submitter: | Entra Health Systems |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Address: | 3111 Camino Del Rio North<br>Suite 101<br>San Diego CA 92108 |
| C. Corporate Contact: | Richard Strobridge, CEO<br>Entra Health Systems |
| D. Telephone: | Ph: 877-458-2646<br>Fax: [phone] |
| E. Submission Contact: | Richa Padhya - Quality<br>Entra Health Systems<br>3111 Camino Del Rio North<br>Suite 101<br>San Diego CA 92108<br>Ph: 877-458-2646 Extension# 723<br>[e-mail] |
| F. Trade Name: | MyGlucoHealth Wireless System |
| G. Predicate Device(s): | MyGlucoHealth Glucose Monitoring System,<br>Model MGH-BT1,<br>Entra Health Systems (K081703) |
| H. Common Name: | Glucose Test System |
| I. Classification: | Class II |

| Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class |
|----------------------|-----------------|--------------------------|-----------------|
| 862.1345 | NBW | Glucose Test System | II |
| 862.1345 | CGA | Glucose Oxidase, Glucose | II |

J. Device Description

> The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930).

> The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand,

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" being inside of a red circle. The letters are separated by vertical lines. Below the letters is the text "Entra Health Systems" in a red font.

Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax [phone]

upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

- K. Intended Use
The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand, upper arm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steadystate times (when glucose is not changing rapidly).

- L. Predicate Device(s)
L.1 MyGlucoHealth Wireless System is substantially equivalent to the following FDA cleared predicate device:

| Predicate #1 |
|--------------|
|--------------|

| 510(k) Number: | K081703 |
|--------------------|-----------------------------------------|
| Trade Name: | MyGlucoHealth Glucose Monitoring System |
| Manufacturer: | <b>Entra Health Systems</b> |
| Common/Usual Name: | Glucose Test System |
| Regulation Number: | 862.1345 |
| Product Codes: | NBW |
| Classification: | II |

- M. Substantial Equivalence

| Feature | Predicate device | Candidate Device |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MyGlucoHealth | MyGlucoHealth Wireless |
| | MGH-BT1 | MGH-CL1 |
| Intended Use | The MyGlucoHealth glucose monitoring<br>system provides a quick and easy way for<br>diabetic patients to measure and self-<br>monitor blood glucose levels. The system<br>is comprised of the MyGlucoHealth<br>Bluetooth meter (MGH-BT1 w/Bluetooth<br>Wireless download capability) or the<br>MGH-1 (w/o Bluetooth) blood glucose<br>meter, control solution and test strips<br>that carry a biosensor used for the<br>quantitative measurement of the<br>concentration of glucose in capillary<br>whole blood that can be taken from the | The MyGlucoHealth Wireless System<br>is intended for self-testing outside the<br>body (in vitro diagnostic use) by<br>people with diabetes at home as an aid<br>to monitor the effectiveness of glucose<br>control. The system is comprised of<br>the MyGlucoHealth Wireless Meter,<br>MyGlucoHealth Control Solutions and<br>MyGlucoHealth Wireless Test Strip.<br>The system is intended to be used for<br>the quantitative measurement of<br>glucose (sugar) in whole blood<br>samples drawn from the fingertip, |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" being inside of a red circle. The letters are separated by vertical lines. Below the letters, the words "Entra Health Systems" are written in red.

Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax [phone]

| | fingertip, ventral palm, hand, upper arm,<br>forearm, calf and/or thigh by diabetic<br>patients or health care professionals. The<br>results obtained are plasma calibrated to<br>allow for easy comparison to the<br>laboratory method. Further, results from<br>either meter may be uploaded to a<br>memory device through a standard RS32<br>connection, or, with the -BT1 model,<br>Wirelessly transmitted to a Bluetooth<br>capable PC or Cell phone. The<br>MyGlucoHealth glucose monitoring<br>systems are not to be used for the<br>diagnosis or screening of diabetes or for<br>neonatal use. Alternate site testing<br>should be done during steady-state times<br>when glucose is not changing rapidly. | ventral palm, hand, upper arm,<br>forearm, calf and/or thigh. The<br>MyGlucoHealth Wireless Meter is<br>intended to be used by a single patient<br>and should not be shared. The<br>MyGlucoHealth Wireless System is<br>not to be used for the diagnosis of or<br>screening for diabetes or for neonatal<br>use. Alternate site testing should be<br>done during steady-state times (when<br>glucose is not changing rapidly). |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control solution | Single (Specified) Analyte Controls<br>(Assayed And Unassayed) | Same as Predicate device |
| Test strips | Glucose Oxidase | Same as Predicate device |
| Test range | 10~600 Mg/dL | Same as Predicate device |
| Hematocrit | 20~60% | Same as Predicate device |
| Range | | |
| Test time | 3 sec | Same as Predicate device |
| Sample Volume | 0.3 uL | Same as Predicate device |
| Operating Temp<br>& Humidity | 50~104°F<br>10~40°C<br>10~90% | Same as Predicate device |
| Speaking<br>Function | No | Same as Predicate device |
| Test Strip Open<br>use time | 3 months | Same as Predicate device |
| Coding | Coding | Same as Predicate device |
| Memory<br>capability | 250 readings | Same as Predicate device |
| Day Averages | 7, 14, 21-day average | Same as Predicate device |
| Battery | Two Triple A's | Lithium Ion Battery |
| Battery Life | 2,000 tests | Rechargeable |
| Size (LxWxH) | 52.2 x 98.5 x 23.4 mm | 53 x 102 x 20.5 mm |
| Weight | 74.5g (2.5 oz.) with battery | 87g (3.06 oz.) with battery |
| Warranty | 2 years | Same as Predicate device |
| Software | MyHealthPoint TeleHealth Manager<br>(K132930) | Same as Predicate device |
| Data transferring<br>capability | MGH-BT1 adds Wireless uploading to Bluetooth paired PC, USB cord or cell phone | MCH-CL1 uploads through a cellular radio |
| Technological<br>Characteristics | The MyGlucoHealth Bluetooth meter<br>(MGH-BT1) consists of a glucose meter | The MyGlucoHealth Wireless Meter<br>consists of a glucose meter that can |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" in a red circle. The words "Entra Health Systems" are written in a red font below the logo. The letters are separated by thin vertical lines.

| | that can Wirelessly transmit data to a<br>remote database using standard<br>Bluetooth technology embedded within<br>the glucose meter. The meter uses<br>biosensor test strips. MyHealthPoint<br>TeleHealth Manager consists entirely of<br>software run on a central server. | wirelessly transmit data to a remote<br>database using standard cellular<br>technology embedded within the<br>glucose meter. The meter uses<br>biosensor test strips. MyHealthPoint<br>TeleHealth Manager consists entirely<br>of software run on a central server. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color | Silver | Black |
| LED light where<br>the test strip is<br>inserted | No LED Light | The LED light is to help the consumer<br>know where to insert the test strip.<br>Also, if they take a reading in the dark<br>it is easier to locate where the test<br>strip needs to be inserted. |
| Alarm | Yes | Same as Predicate device |
| Screen Display | LCD | Same as Predicate device |

- N. Standard/Guidance Document References
- ISO 15197:2003, In Vitro Diagnostic Test Systems Requirements for Blood Glucose ● Monitoring Test Systems for Self Managing Diabetes Mellitus
- ISO 14971:2012, Medical Devices, Application of risk management to medical devices
- IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- IEC 61010-2-101:2002, Safety requirements for electrical equipment for measurement, ● control, and laboratory use - Part 2-101: Particular requirements for IVD medical equipment
- O. Non-Clinical Testing
- 1. Test Report for IEC 61010-1/ EN61010-1 "Safety Requirements for electrical equipment for measurement, control and laboratory use.
- FCC Test Report 2.
- EMC Test Report 3.
- 4. Cleaning Validation Test Reports

All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate.

- P. Clinical Testing
- 1. Human Factor testing was conducted to evaluate the ease of use of the MyGlucoHealth Wireless Meter and ease of understanding the user manual it is paired with.
- Q. Infection Control

Robustness Testing: Cleaning and disinfection can be accomplished by wiping the meter with Caviwipes XL (EPA Reg. No. 46781-8). The robustness study was conducted on three different meters and the results demonstrated that there was no change in functional

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E," "h," and "S," separated by vertical lines. The "h" is in lowercase and is inside a red circle. Below the letters is the text "Entra Health Systems" in a red serif font.

Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax [phone]

performance or in the visual external materials of the meter after 156 cleaning and 156 disinfection cycles to simulate 3 years of use for single patient use. Each robustness cycle tested consisted of one cleaning wipe and one disinfecting wipe.

Cleaning Validation test: Disinfection efficacy/Cleaning Validation studies were performed on the materials comprising the meter by an outside testing laboratory demonstrating complete inactivation of duck hepatitis B virus with the chosen disinfectant, Caviwipes XL (EPA Registration #46781-8. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

- R. Conclusion
The MyGlucoHealth Wireless System is substantially equivalent to the predicate device.