The EasyMax BT 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 EasyMax BT meter and the EasyMax BT test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Device Description

The modified device of EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The 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 system also includes the control solution which is used to check the performance of the system.

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 is a 510(k) premarket notification for the EasyMax BT Self-Monitoring Blood Glucose System. It outlines the device's intended use, comparison to a predicate device, and the design control activities undertaken for modifications.

However, the document does not contain specific acceptance criteria tables nor detailed performance study results (accuracy, precision, or clinical performance data) that would typically be used to prove the device meets these criteria. It primarily focuses on the regulatory submission process, risk analysis, and verification/validation activities that address the addition of a Bluetooth dongle and associated software changes, rather than the core accuracy or clinical performance of the blood glucose measurement itself.

The document mentions that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT 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." This indicates that such data exists in other reports submitted to the FDA, but it is not present in this public summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, expert involvement, adjudication, or specific performance study types like MRMC or standalone studies.

Based only on the provided text, here's what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states that "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." This implies that performance data exists in other, unprovided reports.
2. Sample sized used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This device measures glucose, a quantitative value, not interpreted by experts in the typical sense of imaging. The ground truth would be established by a reference laboratory method.
4. Adjudication method for the test set: Not applicable or not provided.
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. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement system for glucose. The performance of the blood glucose measurement itself would be a standalone assessment against a reference method. However, the details of such a study are not provided in this document.
7. The type of ground truth used: For a blood glucose monitoring system, the ground truth is typically a laboratory reference method (e.g., YSI analyzer) for blood glucose concentration. This is not explicitly stated but is standard for such devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device in the sense of modern deep learning, but rather an electrochemical device. There isn't a "training set" in the common AI/ML context.
9. How the ground truth for the training set was established: Not applicable.

What the document DOES discuss related to "acceptance criteria" and "proof":

The document focuses on the modifications to an already cleared predicate device (EasyMax MU SMBGS) and the testing done to ensure these modifications did not negatively impact safety or essential performance.

Acceptance Criteria Mentioned (for specific modifications):
- Readability Test for Product Name Change: Flesch-Kincaid grade level $\leq$ 8.0 for all inserts.
"Study that proves the device meets the acceptance criteria" (for modifications):
The document lists several "Verification and Validation activities" performed due to the addition of the Bluetooth dongle and software changes:
- Safety Test: IEC 61010-1:2010; IEC61010-2-101:2002
- EMC Test: IEC 60601-1-2:2014; 61326-1:2001
- FCC test: FCC Part 15 Subpart B & C
- Human Factor Test: IEC 62366-1:2015
- Drop and Vibration Test: ISTA 2A: 2011; IEC60068-2-64: 2008
- Software Validation Test: IEC 62304:2006; FDA guidance Document "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices."

The document states that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT 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."

In summary, the provided text serves as a regulatory summary of modifications to a previously cleared device, asserting that necessary testing (including, but not detailed, performance similar to the predicate) has been conducted and documented in other reports to ensure substantial equivalence. It does not contain the detailed clinical or analytical performance study results themselves.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 24, 2018

EPS Bio Technology Corp. Cynthia Hung Official Correspondent No. 8, R&D Rd. III Hsinchu Science Park Hsinchu. 30077 Taiwan

Re: K182057

Trade/Device Name: EasyMax BT Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 30, 2018 Received: July 31, 2018

Dear Cynthia Hung:

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.

{1}------------------------------------------------

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -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

{2}------------------------------------------------

Indications for Use

510(k) Number K182057

Device Name

EasyMax BT Self Monitoring Blood Glucose system

Indications for Use (Describe)

The system consists of the EasyMax BT meter and the EasyMax BT meter only is used with the EasyMax BT 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)
----------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

July, 16, 2018

Type of 510(k): Special 510(k)

510(k) number: K182057

Submitter Information

Company Name:	EPS Bio Technology Corp.
Address:	No. 8, R&D Rd.III Hsinchu Science Park, Hsinchu city 30077Taiwan, R.O.C
Phone:	+886-3-6686-868
Fax:	+886-3-6686-866
Contact Person:	Cynthia Hung
E-mail:	cynthia@epsbio.com.tw

Device Name

Proprietary Name:	EasyMax BT 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

{4}------------------------------------------------

Intended Use

The system consists of the EasyMax BT meter and the EasyMax BT test strips. The EasyMax BT meter only is used with the EasyMax BT 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	EasyMax MUK121207	EasyMax BT
Intended use	EasyMax MU Self Monitoring BloodGlucose System is intended for thequantitative measurement of glucose infresh capillary whole blood fromfingertip, palm, or forearm. Testing isdone outside the body (In Vitrodiagnostic use). It is indicated for use athome (over the counter [OTC]) by asingle patient with diabetes and shouldnot be shared, as an aid to monitor theeffectiveness of diabetes control. Thesystem is not to be used on neonates,nor for the diagnosis of, or screening fordiabetes mellitus. Alternative sitetesting can be only used duringsteady-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
Operatingcondition	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 Derricyanide	Same as predicate
Coding	No code	Same as predicate
Memory Capacity	480 tests	Same as predicate
MeasurementUnit	mg/dL	Same as predicate
MeasurementMode	Test Mode and Control Solution Mode	Same as predicate
Memory Setting	Review 480 results	Same as predicate
Power Supply	Alkaline battery *2	Same as predicate
Battery Life	Over 2000 tests	Same as predicate
Button	Power, left and right buttons	Same as predicate
LCD Dimension	34.0 x 42.0 mm	Same as predicate
Meter Dimension	95 x 50 x 15 mm	Same as predicate
Weight	39.1 grams w/o batteries	Same as predicate
Data Transfer	N/A	Bluetooth Dongle
Meter picture	Image: EASYMAX meter	Image: EASYMAX meter

Comparison to the Predicate

{5}------------------------------------------------

EPS Bio Technology Corp. 510K) Summary of EasyMax BT Self-monitoring Blood Glucose System (As required by 21 CFR 807.92)

July, 16, 2018

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

1. Addition of the Bluetooth dongle to the meter: wireless data transfers to a mobile device and the meter can communicate with a mobile by GlucoManager App.

{6}------------------------------------------------

July, 16, 2018

1. Software(firmware) changes for Bluetooth pairing and Bluetooth transmission functions
  Image /page/6/Picture/3 description: The image shows a smartphone and a blood glucose meter. The smartphone screen displays the GlucoManager app with the text "No data" in the center, indicating that no data has been recorded yet. The blood glucose meter has a display showing three dashes and a Bluetooth symbol, suggesting it is ready to pair with a device.
1. Change the product name
  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 meters
-Uses the same glucose test strips

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. The EasyMax BT SMBG system was modified with adding Bluetooth Dongle and a Failure Modes and Effects Analysis (FMEA) was assessed to identify potential hazard and unaccepted risks, like transmission/communication problems, safety issues, and operating BT function. The control measures were to mitigate these risks to acceptable level with the Safety and EMC testing, FCC testing, Software function testing and human factor study. The complete analysis was in EasyMax BT SMBGS risk management report in this submission.

{7}------------------------------------------------

July, 16, 2018

Verification and Validation activities

Modification	Tests	Standards & References
Addition of theBluetooth dongle tothe meter	Safety Test	IEC 61010-1:2010;IEC61010-2-101:2002
	EMC Test	IEC 60601-1-2:2014; 61326-1:2001
	FCC test	FCC Part 15 Subpart B & C
	Human FactorTest	IEC 62366-1:2015
	Drop andVibration Test	ISTA 2A: 2011; IEC60068-2-64: 2008
Software(firmware)changes forBluetooth pairingand Bluetoothtransmissionfunctions	SoftwareValidation Test	IEC 62304:2006;FDA guidance Document "Guidancefor the Content of Pre-marketSubmissions for Software Containedin Medical Devices".
	Change productname	Readability Test	For all inserts, the accept criteria:Flesch-Kincaid grade level $\leq$ 8.0

The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT 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 BT 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.