The EASYMAX® Tag Self-Monitoring Blood Glucose System is comprised of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The kit is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

Device Description

The modified device of EASYMAX® Tag (EM Tag) self-monitoring blood glucose system is derived from the existing device of EasyMax MU glucose meter and the modified device contain the NFC (Near-field communication) function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EASYMAX® Tag Self-Monitoring Blood Glucose System, which is an updated version of a previously cleared device. While the document broadly discusses verification and validation activities and risk analysis, it does not provide the specific details required to answer all parts of your request.

Here's what can be extracted and what information is missing:

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

The document states: "The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission."

However, the specific acceptance criteria (e.g., accuracy percentages within certain glucose ranges) and the reported device performance against those criteria are not provided in this summary. These details would typically be found in the actual validation reports (Software Validation Report, Risk Management Report, etc.) which are referenced but not included here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. Since this is a blood glucose monitoring system, the ground truth would likely be established using a laboratory reference method, not expert consensus in the way it would be for imaging.

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

This information is not provided in the given text.

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

An MRMC study is relevant for devices where human interpretation of medical images or data is involved and the AI assists that interpretation. This device is a self-monitoring blood glucose system which directly provides a numerical measurement to the user. Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI assistance would not be applicable to this type of device.

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

This device is a standalone system in the sense that it provides a direct measurement. The "algorithm only" aspect would refer to the internal functioning of the meter in conjunction with the test strip. The document indicates that "the design outputs met pre-determined design inputs was confirmed in the software validation report," implying that the standalone performance of the device's measurement function was evaluated. However, specific performance metrics are not provided in this summary.

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

For a blood glucose monitoring system, the ground truth would typically be established by a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer). While the document does not explicitly state this, it is standard practice for such devices.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text. For a blood glucose meter, the ground truth for any training (or calibration) would typically be established using a laboratory reference method.

In summary, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions that verification and validation activities were performed according to risk analysis and that design outputs met design inputs. However, it does not include the detailed performance data, sample sizes, ground truth establishment specifics, or expert qualifications that would be found in the full validation reports.

Summary

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September 1, 2021

EPS Bio Technology Corp. Steve Tseng OA Manager No. 8 R&D RD.III Hsinchu Science Park Hsinchu City, 30077 Taiwan

Re: K201258

Trade/Device Name: EASYMAX Tag Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: January 20, 2021 Received: January 22, 2021

Dear Steve Tseng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201258

Device Name

EASYMAX® Tag Self-Monitoring Blood Glucose System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary of EASYMAX® Tag Self-Monitoring Blood Glucose System (As required by 21 CFR 807.92)

Type of 510(k):	Special 510(k)
510(k) Number:	K201258
Submitter Information
Company Name:	EPS Bio Technology Corp.
Address:	No. 8, R&D Rd.III Hsinchu Science Park, Hsinchu city 30076Taiwan, R.O.C
Phone:	+886-3-6686868#601
Fax:	+886-3-6686866
Contact Person:	Steve Tseng
E-mail:	Steve.tseng@epsbio.com.tw

Device Name

Proprietary Name:	EASYMAX® Tag Self-Monitoring Blood Glucose System
Common Name:	Blood Glucose Test System
Product Code:	NBW
Classification Name:	Blood Glucose Test System, Over-the Counter
Classification:	Class II
Regulation Number:	21 CFR 862.1345

Predicate Device

Proprietary Name:	EasyMax MU Self-Monitoring Blood Glucose System
510(k) Number:	K121207

Device Description

The modified device of EASYMAX® Tag (EM Tag) self-monitoring blood glucose system is derived from the existing device of EasyMax MU glucose meter and the modified device contain

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the NFC (Near-field communication) function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The system consists of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The EASYMAX® Tag meter only is used with the EASYMAX® Tag test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

Special Conditions for Use Statement(s): C

OTC Over The Counter
For in vitro diagnostic use
The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended to be used by a single patient and should not be shared.
The system is not to be used on neonates, nor for the diagnosis of, or screening for

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diabetes mellitus.

Should not be used at altitude above 10,000 feet as there may be an inaccurate test results.
A hematocrit (percentage of your blood that is red blood cells) that is either higher than 60% or lower than 20% can cause inaccurate results.
Use of this device on multiple patients may cause the potential risk to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

D Special Instrument Requirements:

EASYMAX® Tag Blood Glucose Meter

Comparison to the Predicate

Similarities
Item	Predicate Device	Modified Device
Name	EasyMax MUK121207	EASYMAX® TagK201258
Intended use	EasyMax MU Self-MonitoringBlood Glucose System is intendedfor the quantitative measurement ofglucose in fresh capillary wholeblood from fingertip, palm, orforearm. Testing is done outside thebody (In Vitro diagnostic use). It isindicated for use at home (over thecounter [OTC]) by a single patientwith diabetes and should not beshared, as an aid to monitor theeffectiveness of diabetes control.The system is not to be used onneonates, nor for the diagnosis of,or screening for diabetes mellitus.Alternative site testing can be onlyused during steady-state bloodglucose conditions.	Same as predicate
Sample type	Fresh capillary whole blood	Same as predicate

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Image /page/6/Picture/0 description: The image shows the logo for EPS, which is a company that specializes in providing solutions for the energy industry. The logo is a stylized version of the letters "EPS" in blue. The letters are connected to each other, and the logo has a modern and clean look. The logo is simple and memorable, and it effectively communicates the company's brand identity.

Sample site	Finger, palm or forearm.	Same as predicate
Sample Volume	0.6 uL	Same as predicate
Reaction Time	5 seconds	Same as predicate
Measuring Range	20-600 mg/dL	Same as predicate
Hematocrit (HCT) Range	20-60%	Same as predicate
Operating condition	50-104°F(10-40°C)<90 % RH	Same as predicate
Storage Condition	38-86°F(2-30°C)40-85% RH	Same as predicate
Detection method	Electrochemical biosensortechnique	Same as predicate
Enzyme	FAD glucose dehydrogenase	Same as predicate
Mediator	Potassium Ferricyanide	Same as predicate
Pin assignment of Teststrip electrode	Image: Barcode	Same as predicate
Coding	No code	Same as predicate
Measurement Unit	mg/dL	Same as predicate
Meter Case material	Polycarbonate (PC)	Same as predicate
Meter Case Texture	Non-Textured Surface	Same as predicate

Differences
Item	Predicate Device	Modified Device
Power Supply	1.5V AAA *2	CR2032 * 1
Battery Life	Over 2000 tests	Around 1000 times
Meter shape	oval shape	rectangle shape
Meter color	Black	White
Button	3 buttons	2 buttons
Meter Dimension	94(L) x 50 (W) x 19.5(T) mm	74(L) × 47(W) × 12.4 (T) mm
Weight w/o battery	39 grams	26 grams
LCD Dimension	45.0 x 36.0 mm	28(L) × 29(W)mm

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Image /page/7/Picture/0 description: The image shows the logo for EPS in blue. The logo is a stylized version of the letters "EPS" with a modern and geometric design. The letters are bold and connected, giving the logo a sense of unity and strength. The color blue is often associated with trust, reliability, and professionalism, which may be the intended message of the logo.

Display icons
Strip Insert location	Upper meter	Lower meter
Strip Ejector	Yes	No
Memory sets	480 test results	880 test results
Memory mode	N/A	Average on 7/14/30/90 days
Measurement Mode	Test Mode and Control SolutionMode	Test Mode (before meal, aftermeal) and Control SolutionAuto Measurement Mode
High/ Low Limit Function	N/A	High/ Low Setting and Glucoselevel indication
Data Transfer	N/A	NFC

In comparison with the predicate device, the modifications of the proposed device are as below:

1. Change the product name.
1. Hardware changes for power supply and also for battery life.
1. Meter outlook change with shape, color, buttons, dimension, weight, LCD dimension, display icon, insert location of test strip and strip ejector.
1. Software(firmware) changes with meter functions for display icons, buttons, memory mode, Test Mode (before meal, after meal), Control Solution Auto Measurement Mode and High/ Low Limit function.
1. Addition of the NFC function (hardware and firmware changes): wireless data transfers to a mobile device and the meter can communicate with a mobile by EzGluco TAG App.

Other than the above modification, the following remains the same to the predicate device:

-Has the same intended use
-Uses the same operating principle
Uses the same glucose test strips -

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Due to the addition of wireless data transfer function, cybersecurity also becomes a necessary item for risk control. There is a risk analysis of software (firmware) about the data transmission list in risk management report. And, another summary plan & report about the intra-structure control can confirm this cybersecurity issue.

Summary of Design Control Activities

Based on the modifications, the risk analysis was assessed and the risks were identified and controlled with verifications and validation activities which mitigated the risk index to acceptability. The risk analysis and design control activities were summarized below:

Risk Analysis

The risk analysis was conducted according to ISO 14971:2007 standard. A Failure Modes and Effects Analysis (FMEA) was assessed to identify potential hazard and unaccepted risks for each modification. The control measures were to mitigate these risks to acceptable level with the implemented verification and validation activities. The complete analysis was in EASYMAX® Tag SMBGS risk management report in this submission.

Verification and Validation activities

The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EASYMAX® Tag SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission.

Conclusion

The modified device, EASYMAX® Tag SMBGS, has the same intended use and fundamental scientific technology as the predicate, EasyMax MU SMBGS which received 510 (k) clearance K121207.

After conducting risk analysis and design control activities, the modified device 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.