MDT2 BLE Self-Monitoring Blood Glucose System

K190189 · Eps Bio Technology Corp. · NBW · Nov 1, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190189
• Device Name: MDT2 BLE Self-Monitoring Blood Glucose System
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This MDT2 BLE Self-Monitoring Blood Glucose System is intended for single-patient use only.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor; uses FAD glucose dehydrogenase enzyme and potassium ferricyanide mediator. Input: 0.6 uL blood sample on test strip. Meter measures electrical current proportional to glucose concentration; displays result. Intended for home use by single patient. Includes Bluetooth for wireless data transfer to mobile app. Modifications from predicate (EM40) include physical form factor (rectangle vs oval), button configuration, display icons, and addition of Bluetooth connectivity. Healthcare provider uses results to monitor diabetes control effectiveness. Benefits patient through convenient, wireless tracking of glucose levels.

Clinical Evidence

No clinical data provided. Substantial equivalence established through bench testing, risk analysis, and design verification/validation activities confirming that modified device meets pre-determined design inputs.

Technological Characteristics

Glucose test system; electrochemical sensing. Features Bluetooth connectivity. Physical dimensions: 98 x 49.9 x 11.3 mm; weight: 49g. Powered by batteries. Validated for cleaning/disinfection with PDI Sani-Cloth Germicidal wipes.

Indications for Use

Indicated for single-patient use for the self-monitoring of blood glucose levels.

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

• EM40 Self-Monitoring Blood Glucose System (K133389)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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 ([e-mail]) or phone [phone] 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)

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.

| 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) | <div> <span> ☒ </span> </div> |

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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: | [phone] | |
| Fax: | [phone] | |
| Contact Person: | RF Jain | |
| E-mail: | [e-mail] | |
| 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

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.

# 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.

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.

| Similarities and Differences | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Item | Predicate Device | Modified Device |
| Name | EM40<br>K133389 | 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)<br><90 % RH | Same as predicate |
| Storage Condition | 35.6-86°F(2-30°C)<br>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 of<br>Test 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.
- 2. 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.
- 3. Change the electrode pin assignment of test strip.
- 4. 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.
- 5. 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.