The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.

The iHealth Wireless Gluco-Monitoring 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 diabetes control. The iHealth Wireless Cluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Device Description

The iHealth wireless Smart Gluco-Monitoring System(BG5) consist of blood qlucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.

In order to use theiHealth wireless Smart Gluco-Monitoring System(BG5), a compatible Android or iOS mobile device with the necessary mobile application installed is required.

AI/ML Overview

The provided text describes a glucose monitoring system, not an AI device. As such, the typical acceptance criteria and study elements associated with AI are not directly applicable.

However, I can extract information related to the performance criteria and validation study for the iHealth Wireless Smart Gluco-Monitoring System (BG5) as presented in the 510(k) summary. This device is a blood glucose meter, and its performance is assessed against accuracy standards for glucose measurements.

Here's an interpretation based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with "reported device performance." However, it implies that the device meets the performance of its predicate device, as claimed in section 8.0. For glucose meters, the typical acceptance criteria are established by standards like ISO 15197 (Accuracy requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus). While these specific ISO criteria are not directly listed as "acceptance criteria" here, the declaration of "substantial equivalence" implies adherence to such recognized performance standards.

The document states:

Measurement Range: 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L)
Test Time: 5 seconds
Sample Volume: Minimum 0.7 microliter
Hematocrit Range: 20-60%

The comparison table (Section 7.0) indicates that the new device has the same characteristics as the predicate device (K123935) for these performance parameters, implying it meets the same performance as the predicate.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (New Device)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Sample Source	Capillary whole blood from AST and finger	Capillary whole blood from AST and finger
Hematocrit Range	20-60%	20-60%
Operating Temp.	10℃~35℃ (50°-95°F)	10℃~35℃ (50°-95°F)
Measurement Range	20mg/dL-600mg/dL	20mg/dL-600mg/dL
Sample Volume	Minimum 0.7 micro liter	Minimum 0.7 micro liter
Test Time	5 second	5 second

The key statement regarding meeting criteria is in Section 8.0: "the test in this submission provides demonstration that these small differences [connect to Android] do not raise any new questions of safety and effectiveness." This implies that the device's accuracy and performance are considered equivalent to the predicate, which would have met its own set of performance criteria, likely aligning with ISO 15197 for glucose meters.

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

The document does not explicitly state the sample size used for performance testing (e.g., number of subjects, number of blood samples). It also doesn't specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "the test in this submission."

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. For glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert interpretation, so the concept of experts establishing ground truth in this context is less relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is for a glucose meter and not an AI or imaging device requiring human expert adjudication.

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:

Not applicable, as this is a standalone glucose meter, not an AI-assisted diagnostic tool.

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

Yes, the device itself is a standalone glucose monitoring system. Its performance is evaluated on its ability to accurately measure glucose levels independent of human interpretation or AI assistance. The output is a numerical glucose reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For a glucose meter, the ground truth is established by comparison to a laboratory reference method, typically a YSI glucose analyzer, which is considered highly accurate for quantitative glucose measurement in blood. This is standard for glucose meter validation, though not explicitly detailed in this summary.

8. The sample size for the training set:

Not applicable. This device is not an AI model requiring a "training set." It's a hardware medical device with electrochemical sensing technology.

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

Not applicable, as there is no training set for this type of device.

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, stacked on top of each other.

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

August 19, 2016

ANDON HEALTH CO., LTD LIU YI, PRESIDENT NO. 3 JINPING STREET, YA AN ROAD, NANKAI DISTRICT TIANJIN, P.R. CHINA

Re: K153278

Trade/Device Name: iHealth Wireless Smart Gluco-Monitoring System (BG5) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP Dated: August 11, 2016 Received: August 15, 2016

Dear Mr. Yi:

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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Page 2-Mr. Yi

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,

Stayce Beck -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

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Indications for Use

510(k) Number (if known) K153278

Device Name

iHealth Wireless Smart Gluco-Monitoring System (BG5)

Indications for Use (Describe)

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)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

Name:	Andon Health Co., Ltd.
Address:	No.3 Jinping Street, Ya'an Road, Nankai District, Tianjin,P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Yi Liu
Date of Preparation:	11/05/2015

2.0 Device information

Trade name:	iHealth Wireless Smart Gluco-Monitoring System (BG5)
Common name:	Blood Glucose Monitoring System
Classification name:	Blood Glucose Monitoring System

3.0 Classification

NBW- Blood Glucose Monitoring System. Production code: Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry

Production code: CGA- test, blood glucose, over the counter Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry

JQP Production code: Regulation number: 862.2100 Classification: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Panel: Clinical Chemistry

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4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd.

iHealth BG5 WIRELESS SMART GLUCOSE MONITORING Device: SYSTEM

510(k) number: K123935

5.0 Device description

The iHealth wireless Smart Gluco-Monitoring System(BG5) consist of blood qlucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

In order to use theiHealth wireless Smart Gluco-Monitoring System(BG5), a compatible Android or iOS mobile device with the necessary mobile application installed is required.

6.0 Intended use

The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco-Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared.

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used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

7.0 Summary comparing technological characteristics with predicate device

CHARACTERISTICS	NEW DEVICE:iHealth wireless SmartGluco-MonitoringSystem(BG5)	PREDICATE:iHealth BG5 wireless SmartGluco-MonitoringSystem(K123935)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Type of Meter	Biosensor (Electrode)	Biosensor (Electrode)
Sample Source	Capillary whole blood fromAST(Alternative site testing)and finger	Capillary whole blood fromAST(Alternative site testing)and finger
Sample Application	Blood sample is placeddirectly to the test strip afterfinger or AST is lanced.	Blood sample is placeddirectly to the test strip afterfinger or AST is lanced.
Hematocrit Range	20-60%	20-60%
OperatingTemperature Range	10℃~35℃(50°-95°F)	10℃~35℃(50°-95°F)
Dimensions	9mm × 34.5mm ×19mm	9mm × 34.5mm ×19mm
Display	Connect to iOS device andandroid device to displaymeasurement results	Connect to iOS device todisplay measurement results
Result Presentation	mg/dL or mmol/L	mg/dL or mmol/L
Memory Capabilities	500 times with time and datedisplaying	500 times with time and datedisplaying
Test Start	Automatic	Automatic
Test Time	5 second	5 second
Power Source	DC 3.7V d.c.li-ion 250mAh	DC 3.7V d.c.li-ion 250mAh
Battery Life	N/A	N/A
Measurement Range	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)	20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L)
Qualified Test Strip	AGS 1000I Test Strip	AGS 1000I Test Strip
Sample Volume	Minimum 0.7 micro liter	Minimum 0.7 micro liter
Connect Method	Connect to iOS device andAndroid device throughbluetooth	Connect to iOS devicethrough bluetooth

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8.0 Comparison to the predict device and the conclusion

The proposed device is similar with the predicate device BG5, they are both for single patient use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same. However, the proposed device can be connected to not only the iOS device, but also the Android device.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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.