The EasyPlus mini R9N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The EasyPlus mini R9N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The EasyPlus mini R9N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

EasyPlus mini R9N Glucose Control Solutions: For use with the EasyPlus mini R9N meter and EasyPlus mini R9N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text, focusing on Acceptance Criteria and the Study that proves the device meets those criteria, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text (FDA 510(k) summary) does not explicitly state the acceptance criteria in a table format with corresponding reported device performance for a study. Instead, it refers to the device being substantially equivalent to legally marketed predicate devices. This implies that the device's performance is expected to be comparable to established devices in the market that have already met certain performance standards.

The indications for use describe the intended performance capabilities, but not specific numerical acceptance criteria. For example, it measures "quantitative measurement of glucose" and acts as "an aid to monitor the effectiveness of diabetes control."

To provide a hypothetical table based on typical glucose meter requirements, and assuming the device met these implicit standards for substantial equivalence:

Performance Metric (Hypothetical)	Acceptance Criteria (Hypothetical, based on ISO 15197 or similar)	Reported Device Performance (Implied from Substantial Equivalence and typical device data in 510(k)s)
Accuracy (Against Lab Reference)	95% of results within ±15 mg/dL or ±15% of reference for glucose < 100 mg/dL and ≥ 100 mg/dL respectively.	Implied to meet or exceed, resulting in substantial equivalence
Precision/Repeatability (SD or CV)	CV < 5% or SD < 5 mg/dL across measurement range.	Implied to meet or exceed, resulting in substantial equivalence
User Performance/Ease of Use	Successful operation by lay users; low error rates.	Implied to be comparable to predicate devices.
Interfering Substances	No significant interference from common substances.	Implied to be comparable to predicate devices.
Hematocrit Range	Accurate measurements across specified hematocrit range.	Implied to be comparable to predicate devices.

Note: The provided document is a 510(k) clearance letter, which typically summarizes the FDA's decision based on reviewed data. It does not generally contain the detailed study results or explicit acceptance criteria itself. These details would be found in the manufacturer's 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not contain any information regarding the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in the detailed study reports submitted as part of the 510(k) application, not in the FDA's clearance letter.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. For glucose meters, ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel, rather than clinical experts adjudicating images.

4. Adjudication Method

The document does not mention any adjudication method. For glucose meters, the "ground truth" for blood glucose levels is usually determined by a highly accurate laboratory reference instrument, not through multi-expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable: The device discussed is a "Self Monitoring Blood Glucose System" (EasyPlus mini R9N SMBG system), which is an in-vitro diagnostic device for measuring glucose directly. It is not an imaging device or an AI system that assists human readers in interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance would not be relevant or performed for this type of device.

6. Standalone Performance Study (Algorithm Only)

Not Applicable: This device is a blood glucose meter, not an algorithm. Its performance is evaluated as a complete system (meter + strips) in measuring glucose levels directly from blood samples. While it contains internal algorithms for calculation and display, "standalone" algorithm performance in the way it's understood for AI systems (i.e., algorithm only without human-in-the-loop) doesn't apply directly. The entire system's (meter + strip) accuracy and precision are assessed.

7. Type of Ground Truth Used

Based on the nature of a blood glucose monitoring system, the ground truth would typically be established by:

Reference laboratory method: Measurements from a highly accurate and precise laboratory instrument (e.g., YSI glucose analyzer, hexokinase method) on the same blood samples.
Comparison to predicate devices: Performance compared against legally marketed predicate glucose meters.

The document does not explicitly state the type of ground truth used, but this is the standard for such devices.

8. Sample Size for the Training Set

Not Applicable: Blood glucose meters are not typically "trained" in the machine learning sense using a training set of data. Their calibration and performance are based on chemical and electrochemical principles, manufacturing processes, and quality control. There isn't a "training set" in the context of an AI algorithm learning from data.

9. How the Ground Truth for the Training Set was Established

Not Applicable: As explained above, there is no "training set" or "ground truth for a training set" in the context of a blood glucose meter's primary function.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

EPS Bio Technology Corp.
c/o Y.C. Lei
General Manager
No.8 R&D Rd III, Hsinchu Science Park
Hsinchu City, Hsinchu
China (Taiwan) 300

	Food & Drug Administration
	10903 New Hampshire Avenue
	Building 66
	Silver Spring, MD 20993

	JUL 1 2010
--	------------

Re:	K101457
Trade Name:	EasyPlus mini R9N Self Monitoring Blood Glucose System

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: May 21, 2010

Received: June 3, 2010

Dear Mr. Lei:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

(II KNOWN). R. VS. T.

Device Name:

EasyPlus mini R9N SMBG system

Indications for Use:

EasyPlus mini R9N SMBG Test System

EasyPlus mini R9N Meter

EasyPlus mini R9N Blood Glucose Test Strips

EasyPlus mini R9N Glucose Control Solutions

For use with the EasyPlus mini R9N meter and EasyPlus mini R9N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sian-C

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) k10145

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.