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).

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, 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the MyGlucoHealth Wireless System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document refers to the ISO 15197:2003 standard, which outlines requirements for blood glucose monitoring systems. While the specific numerical acceptance criteria from this standard are not explicitly listed in detail within the summary, the summary states that "All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate."

A key aspect of performance for blood glucose monitoring systems is accuracy. Although a detailed table of performance against specific accuracy thresholds (e.g., within X% of a reference method) is not present in this summary, the substantial equivalence claim implies that its performance is comparable to the predicate device, which would have met such criteria.

Note: For a complete understanding of the device's accuracy against ISO 15197:2003, one would typically need to refer to the full test report or the specific performance data submitted with the 510(k) application, which is not fully included here. However, the mention of the standard indicates the type of criteria the device aims to meet.

Acceptance Criteria Category (Implied by ISO 15197:2003, and by "substantial equivalence")	Reported Device Performance (Summary)
Accuracy of glucose measurement (within defined limits)	Demonstrated "safety and effectiveness" and "substantial equivalence to the predicate."
Repeatability/Precision	Implied to meet acceptable standards for blood glucose meters.
Interference with common substances	Implied to meet acceptable standards for blood glucose meters.
System operating conditions (temperature, humidity)	Meets specified operating range: 10-40°C (50-104°F), 10-90% humidity.
Hematocrit range	20-60%
Test range	10-600 Mg/dL
Test time	3 seconds
Sample Volume	0.3 uL
Cleaning and Disinfection Robustness (for re-use)	No change in functional performance or visual materials after 156 cleaning/disinfection cycles (simulating 3 years of use).
Disinfection Efficacy against pathogens	Demonstrated complete inactivation of duck hepatitis B virus with Caviwipes XL.

Study Information

The document describes non-clinical testing and clinical testing.

2. Sample size used for the test set and the data provenance:

Non-Clinical Testing:
- Cleaning Validation Test (Robustness): 3 different meters were tested.
- Cleaning Validation Test (Efficacy): The sample size for materials tested for disinfection efficacy is not specified, but it was performed by an outside testing laboratory.
Clinical Testing (Human Factor testing): The sample size is not specified in the provided summary.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the clinical (human factors) study, or the non-clinical testing. However, given it's for FDA submission, it's generally expected to be prospective for human factors and laboratory-controlled for non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the summary. For a blood glucose meter, the "ground truth" for accuracy assessments is typically established by comparative measurements against a well-established laboratory reference method (e.g., YSI analyzer), rather than expert consensus on individual readings.
For the human factors testing, the definition of ground truth (e.g., successful task completion) would be based on predefined criteria, not expert assessment of individual readings.

4. Adjudication method for the test set:

Not applicable in the context of this summary. Blood glucose meter performance is determined by quantitative comparison to reference methods, not subjective interpretation requiring adjudication among experts. For human factors, task completion or error rates would be measured against predefined success/failure criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to a blood glucose monitoring system like the MyGlucoHealth Wireless System. MRMC studies are typically used for imaging diagnostics where human readers interpret medical images, often with AI assistance. This device is a standalone in vitro diagnostic (IVD) device for quantitative measurement.

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

Yes, the core performance evaluation of the MyGlucoHealth Wireless System is a standalone evaluation. The device itself measures glucose concentration and displays a numerical result. The "algorithm" here refers to the electrochemical principles and calibration within the test strip and meter to convert a biochemical reaction into a glucose reading. The system's accuracy is assessed directly against a reference method.

7. The type of ground truth used:

For glucose measurement accuracy: Typically, a laboratory reference method (e.g., YSI glucose analyzer) is used as the ground truth. This is implied by the adherence to ISO 15197:2003, which requires comparison to a traceable reference measurement procedure.
For cleaning/disinfection efficacy: Specific laboratory standards for viral inactivation are used.
For human factors: Predefined criteria for task completion and user comprehension are typically used to establish ground truth.

8. The sample size for the training set:

This information is not explicitly provided. For a traditional electrochemical blood glucose meter, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, using a variety of samples during development and manufacturing to establish its operating characteristics.

9. How the ground truth for the training set was established:

Not applicable in the machine learning context. For this type of device, ground truth for calibration and development would be established through precise laboratory measurements using reference methods and well-characterized samples over a range of glucose concentrations, hematocrit levels, and interfering substances.

Summary

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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.

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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/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 (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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Indications for Use

510(k) Number (if known) K143169

Device Name MyGlucoHealth Wireless System

Indications for Use (Describe)

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)

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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 619 584 4504

510(k) Summary

A. Submitter:	Entra Health Systems
B. Address:	3111 Camino Del Rio NorthSuite 101San Diego CA 92108
C. Corporate Contact:	Richard Strobridge, CEOEntra Health Systems
D. Telephone:	Ph: 877-458-2646Fax: 619-584-4504
E. Submission Contact:	Richa Padhya - QualityEntra Health Systems3111 Camino Del Rio NorthSuite 101San Diego CA 92108Ph: 877-458-2646 Extension# 723rpadhya@entrahealth.com
F. Trade Name:	MyGlucoHealth Wireless System
G. Predicate Device(s):	MyGlucoHealth Glucose Monitoring System,Model MGH-BT1,Entra Health Systems (K081703)
H. Common Name:	Glucose Test System
I. Classification:	Class II

RegulationNumber	ProductCode	Classification Name	DeviceClass
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,

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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 619 584 4504

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:	Entra Health Systems
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 monitoringsystem provides a quick and easy way fordiabetic patients to measure and self-monitor blood glucose levels. The systemis comprised of the MyGlucoHealthBluetooth meter (MGH-BT1 w/BluetoothWireless download capability) or theMGH-1 (w/o Bluetooth) blood glucosemeter, control solution and test stripsthat carry a biosensor used for thequantitative measurement of theconcentration of glucose in capillarywhole blood that can be taken from the	The MyGlucoHealth Wireless Systemis intended for self-testing outside thebody (in vitro diagnostic use) bypeople with diabetes at home as an aidto monitor the effectiveness of glucosecontrol. The system is comprised ofthe MyGlucoHealth Wireless Meter,MyGlucoHealth Control Solutions andMyGlucoHealth Wireless Test Strip.The system is intended to be used forthe quantitative measurement ofglucose (sugar) in whole bloodsamples drawn from the fingertip,

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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 619 584 4504

	fingertip, ventral palm, hand, upper arm,forearm, calf and/or thigh by diabeticpatients or health care professionals. Theresults obtained are plasma calibrated toallow for easy comparison to thelaboratory method. Further, results fromeither meter may be uploaded to amemory device through a standard RS32connection, or, with the -BT1 model,Wirelessly transmitted to a Bluetoothcapable PC or Cell phone. TheMyGlucoHealth glucose monitoringsystems are not to be used for thediagnosis or screening of diabetes or forneonatal use. Alternate site testingshould be done during steady-state timeswhen glucose is not changing rapidly.	ventral palm, hand, upper arm,forearm, calf and/or thigh. TheMyGlucoHealth Wireless Meter isintended to be used by a single patientand should not be shared. TheMyGlucoHealth Wireless System isnot to be used for the diagnosis of orscreening for diabetes or for neonataluse. Alternate site testing should bedone during steady-state times (whenglucose is not changing rapidly).
Control solution	Single (Specified) Analyte Controls(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& Humidity	50~~104°F10~~40°C10~90%	Same as Predicate device
SpeakingFunction	No	Same as Predicate device
Test Strip Openuse time	3 months	Same as Predicate device
Coding	Coding	Same as Predicate device
Memorycapability	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(K132930)	Same as Predicate device
Data transferringcapability	MGH-BT1 adds Wireless uploading to Bluetooth paired PC, USB cord or cell phone	MCH-CL1 uploads through a cellular radio
TechnologicalCharacteristics	The MyGlucoHealth Bluetooth meter(MGH-BT1) consists of a glucose meter	The MyGlucoHealth Wireless Meterconsists of a glucose meter that can

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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 aremote database using standardBluetooth technology embedded withinthe glucose meter. The meter usesbiosensor test strips. MyHealthPointTeleHealth Manager consists entirely ofsoftware run on a central server.	wirelessly transmit data to a remotedatabase using standard cellulartechnology embedded within theglucose meter. The meter usesbiosensor test strips. MyHealthPointTeleHealth Manager consists entirelyof software run on a central server.
Color	Silver	Black
LED light wherethe test strip isinserted	No LED Light	The LED light is to help the consumerknow where to insert the test strip.Also, if they take a reading in the darkit is easier to locate where the teststrip 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.
- 1. 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

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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 619 584 4504

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.

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.