The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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.

The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Device Description

The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth 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 does not contain detailed information about a study proving the device meets acceptance criteria, specifically not in the format requested for a scientific study with sample sizes, expert qualifications, or comparative effectiveness.

However, based on the information provided, here's what can be inferred and presented, focusing on the acceptance criteria as stated in the context of substantial equivalence for a medical device (MDT2 BLE Self-Monitoring Blood Glucose System):

The document indicates that the MDT2 BLE Self-Monitoring Blood Glucose System is considered "substantially equivalent" to its predicate device, the EM40 Self-Monitoring Blood Glucose System (K133389). This implies that the acceptance criteria for the MDT2 BLE system are aligned with those previously met by the EM40 system, particularly since most core functionalities and technologies remain the same.

The modifications to the MDT2 BLE system are primarily related to its physical design, software features (memory mode, measurement mode, reset function, display icons), and the addition of Bluetooth functionality for wireless data transfer. These modifications were subjected to risk analysis and verified/validated.

Given the information, I can construct a table for what could be considered "acceptance criteria" based on the predicate device's performance, and then note that the new device states it meets these as part of its "substantial equivalence" claim.

Acceptance Criteria for MDT2 BLE Self-Monitoring Blood Glucose System and Reported Device Performance

Feature/Metric	Acceptance Criteria (based on predicate EM40 SMBGS)	Reported Device Performance (MDT2 BLE SMBGS)
Intended Use	Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. For in-vitro diagnostic use at home by a single patient with diabetes as an aid to monitor effectiveness of diabetes control. Not for neonates, diagnosis or screening for diabetes mellitus. Alternative site testing only during steady-state blood glucose conditions.	Same as predicate. The MDT2 BLE Self-Monitoring Blood Glucose System has the same intended use.
Sample Type	Fresh capillary whole blood	Same as predicate.
Sample Site	Finger, palm or forearm	Same as predicate.
Sample Volume	0.6 µL	Same as predicate.
Reaction Time	5 seconds	Same as predicate.
Measuring Range	20-600 mg/dL	Same as predicate.
Hematocrit Range	20-60%	Same as predicate.
Operating Condition	10-40°C (<90% RH)	Same as predicate.
Storage Condition	2-30°C (40-85% RH)	Same as predicate.
Detection Method	Electrochemical biosensor technique	Same as predicate.
Enzyme	FAD glucose dehydrogenase	Same as predicate.
Mediator	Potassium ferricyanide	Same as predicate.
Coding	No code	Same as predicate.
Memory Capacity	480 tests	Same as predicate.
Measurement Unit	mg/dL	Same as predicate.
Power Supply	CR2032 3V *2	Same as predicate.
Battery Life	Over 2000 tests	Same as predicate.
Meter Case Material	Polycarbonate (PC)	Same as predicate.
Meter Case Texture	Non-Textured Surface	Same as predicate.
Fundamental Scientific Technology	Electrochemical principle with FAD glucose dehydrogenase	Same as predicate.
Safety and Effectiveness	Comparable to predicate device	Confirmed through risk analysis (ISO 14971:2007 FMEA) and verification/validation activities. The submission states that risks were identified, controlled, and mitigated to an acceptable level, and that design outputs met pre-determined design inputs, confirmed in a software validation report. The device is deemed "substantially equivalent" to the predicate.

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" are implied by the predicate device's specifications, and the "reported device performance" is the claim of "same as predicate" or confirmed equivalence through V&V activities.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "verification and validation activities" and a "software validation report" but does not specify sample sizes for any test sets used in these activities.
- Data provenance is not explicitly stated in terms of country of origin or whether studies were retrospective or prospective, beyond the fact that the company is located in Taiwan.
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 document. The document refers to "risk analysis" and "verification and validation activities" but not to specific expert panels or their qualifications for establishing ground truth derived from clinical studies. Given this is a self-monitoring blood glucose system, ground truth would typically be established against laboratory reference methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided.
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 this device. An MRMC study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This device is a blood glucose monitoring system. Its performance is compared to laboratory reference methods, not human interpretation of images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is an in-vitro diagnostic device that measures glucose. The "algorithm" here refers to the meter's internal processing of an electrochemical signal into a glucose reading. Its performance is indeed "standalone" in the sense that the meter itself provides the quantitative measurement without human interpretation of the raw signal. The document states "The meter measures the current and displays the blood glucose result." The standalone performance is implicitly claimed through the "substantial equivalence" to the predicate and the verification/validation activities of the new meter's components, including software/firmware changes.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood glucose meters, the ground truth is typically established against laboratory reference methods for glucose measurement (e.g., YSI analyzer). While not explicitly stated here, this is the standard practice for such devices. The document implies verification and validation against established standards and the predicate device, which would have been validated against such ground truth.
The sample size for the training set:
- This information is not provided. The document doesn't detail specific training sets, which is typical for traditional (non-AI/ML) medical devices like blood glucose meters. Even for the software/firmware changes, the term "training set" is not used in this context.
How the ground truth for the training set was established:
- As no training set is mentioned in the context of AI/ML, this is not applicable. For the device's inherent function, ground truth for calibration and testing is against laboratory reference methods.

Summary

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November 1, 2019

EPS Bio Technology Corp. RF Jain No. 8 R&D RD.III Hsinchu Science Park Hsinchu, 30077 Taiwan

Re: K190189

Trade/Device Name: MDT2 BLE Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 1, 2019 Received: October 2, 2019

Dear RF Jain:

We have reviewed vour 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

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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 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 (QS) 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 medical devices and radiation-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. Acting 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) K190189

Device Name

MDT2 BLE Self Monitoring Blood Glucose system

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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EPS Bio Technology Corp.

510(K) Summary of MDT2 BLE Self-monitoring Blood Glucose System (As required by 21 CFR 807.92)

September 30, 2019

Type of 510(k):	Special 510(k)	K190189
Submitter Information
Company Name:	EPS Bio Technology Corp.
Address:	No. 8, R&D Rd.III Hsinchu Science Park, Hsinchu city
	30077 Taiwan, R.O.C
Phone:	+886-3-6686-868
Fax:	+886-3-6686-866
Contact Person:	RF Jain
E-mail:	rf_jain@epsbio.com.tw
Device Name
Proprietary Name:	MDT2 BLE 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:	EM40 Self-Monitoring Blood Glucose System
510(k) Number:	K133389

Device Description

Intended Use

The MDT2 BLE Self-Monitoring Blood Glucose System is intended for the

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September 30, 2019

quantitative measurement of glucose in fresh capillary whole blood from 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.

Similarities and Differences
Item	Predicate Device	Modified Device
Name	EM40K133389	MDT2 BLE

Intended use	EM40 Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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.	Same as predicate
Sample type	Fresh capillary whole blood	Same as predicate
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 Range	20-60%	Same as predicate

Operating condition	50-104°F(10-40°C)<90 % RH	Same as predicate
Storage Condition	35.6-86°F(2-30°C)40-85% RH	Same as predicate
Detection method	Electrochemical biosensor technique	Same as predicate
Enzyme	FAD glucose dehydrogenase	Same as predicate
Mediator	Potassium ferricyanide	Same as predicate
Coding	No code	Same as predicate
Memory Capacity	480 tests	Same as predicate
Measurement Unit	mg/dL	Same as predicate
Memory Setting	Review 480 results	Same as predicate
Power Supply	CR2032 3V *2	Same as predicate
Battery Life	Over 2000 tests	Same as predicate
Meter Case material	Polycarbonate (PC)	Same as predicate
Meter Case Texture	Non-Textured Surface	Same as predicate
Meter shape	Oval shape	Rectangle shape
Meter color	Black	White
Button	One Front button and two side buttons	Two front buttons
Meter Dimension	86 x 47 x 13.8 mm	98 x 49.9 x 11.3 mm
Weight	43 grams w/o batteries	49 grams w/o batteries
LCD Dimension	43.0 x 35.0 mm	55.7 x 36.7 mm
Display icons	Image: Display icons of a blood glucose meter (Real Photo)	Image: Display icons of a blood glucose meter (Drawing)
Strip Insert location	Upper meter	Lower meter
Pin assignment ofTest strip electrode	Image: Pin assignment of Test strip electrode (Upper meter)	Image: Pin assignment of Test strip electrode (Lower meter)
Memory mode	Average on 7/14/30/90 days	No average

Comparison to the Predicate

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510(K) Summary of MDT2 BLE Self-monitoring Blood Glucose System (As required by 21 CFR 807.92)

September 30, 2019

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EPS Bio Technology Corp.

510(K) Summary of MDT2 BLE Self-monitoring Blood Glucose System (As required by 21 CFR 807.92)

September 30. 2019

Measurement Mode	Test Mode and Control Solution Mode	Test Mode (before meal, after meal) and Control Solution Mode
Reset function	N/A	Yes
Bluetooth	N/A	Yes

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

1. Change the product name.
1. Meter outlook change with shape, color, meter buttons, dimension, weight and LCD dimension, the same LCD type with different display icons, and the insert location of test strip.
1. Change the electrode pin assignment of test strip.
1. Software(firmware) changes with meter functions: memory mode, measurement mode, and reset function. And, also for display icons (before meal, after meal, Control, AM, PM icon) and buttons.
1. Addition of the Bluetooth with wireless data transfer function (hardware and firmware changes) : the meter added Bluetooth can communicate with a mobile device 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 power source
-The test strips use the same glucose Enzyme and mechanism

Due to the addition of the Bluetooth with wireless data transfer function, cybersecurity also becomes a necessary item for risk control. There is a cybersecurity summary plan & report to confirm this issue.

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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 MDT2 BLE 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 MDT2 BLE 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, MDT2 BLE SMBGS, has the same intended use and fundamental scientific technology as the predicate, EM40 SMBGS which received 510 (k) clearance K133389.

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.