The BGM009 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). The device includes speaking functions but is not intended for use in visually impaired users. It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Description

The BGM009 blood glucose meter and BGM009 test strips are used for testing of blood glucose.

AI/ML Overview

The provided text focuses on the FDA 510(k) premarket notification for the BGM009 Blood Glucose Monitoring System. It describes the device's intended use, classification, and comparison to a predicate device. While it mentions "clinical testing" and "accuracy study," it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and multi-reader studies are not available in the provided document.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states "Results demonstrate substantial equivalence to the predicate system" for non-clinical and clinical testing, but it does not specify the quantitative acceptance criteria (e.g., accuracy percentages within certain glucose ranges) or the numerical performance results against those criteria.

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

Test Set Sample Size: The document mentions "an accuracy study was conducted with home users" and "disinfection testing with recommended disinfectant wipes was done using an animal virus test model," but it does not specify the sample sizes for either.
Data Provenance: The study on home users is implied to be prospective (a clinical study). The location of the home users (country) is not specified.

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

This information is not provided. The document does not describe how the "ground truth" (reference glucose values) was established for the accuracy study.

4. Adjudication Method

This information is not provided. This concept is typically more relevant for subjective diagnoses from image-based medical devices, which is not the case for a blood glucose monitor.

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

This information is not provided and is not applicable to a blood glucose monitoring system, which provides a numerical output rather than an interpretation requiring multiple readers. The "accuracy study" mentioned is likely comparing device readings to a reference method, not human interpretations.

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The "accuracy study" and "precision testing" described for the blood glucose monitoring system are inherently standalone performance evaluations of the device itself against a reference method.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the accuracy study. For blood glucose monitors, the ground truth is typically established by laboratory reference methods (e.g., YSI glucose analyzer) performed on the same blood samples. This is a common practice in such studies, but not explicitly stated here.

8. Sample Size for the Training Set

This information is not provided. The document makes no mention of a "training set" as it would for a machine learning model. For a device like a blood glucose monitor, the "training" typically refers to the device's calibration and algorithm development, which would use internal data, not a formally defined "training set" in the context of FDA submissions for machine learning.

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

This information is not provided and is not applicable in the same way it would be for AI/ML devices.

In summary, the provided text provides high-level information about the regulatory submission of a blood glucose monitoring system, but it lacks the detailed technical and clinical study results that would allow for a comprehensive answer to the requested questions regarding specific acceptance criteria and study data.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

2015 May 1,

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE, MANAGER OF QUALITY ASSURANCE DEPT. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN

Re: K141036

Trade/Device Name: BGM009 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: April 22, 2015 Received: April 23, 2015

Dear Hsue-mei Lee:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H Lias -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141036

Device Name BGM009 Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, 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.

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

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510(k) Summary

Submitter:	Apex Biotechnology Corp.
	No. 7, Li-Hsin Road V, Hsinchu Science Park
	Hsinchu, 30078
	CHINA (TAIWAN)
Contact Person:	Hsue-mei Lee
	Manager of Quality Assurance Department
	Apex Biotechnology Corp.
	No. 7, Li-Hsin Road V, Hsinchu Science Park
	Hsinchu, 30078
	CHINA (TAIWAN)
	email: hsue-mei@apexbio.com
	Phone: 011-886-3-5641952
	FAX: 011-886-3-5678302
Date Prepared:	Septebmer 10, 2014
Trade Names:	BGM009 Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW
Predicate Devices:	AutoSure Voice II Plus Blood Glucose Monitoring System (K113208)
Device Description:	The BGM009 blood glucose meter and BGM009 test strips are used for
	testing of blood glucose.
Intended Use:	The BGM009 Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips, forearm, or palm. Alternative site testing should beperformed only during steady-state (when glucose is not changing rapidly).The device includes speaking functions but is not intended for use in visuallyimpaired users. It is intended for self testing outside the body (in vitrodiagnostic use) by people with diabetes at home as an aid in monitoring theeffectiveness of diabetes control and should only be used by a single patientand it should not be shared. It is not indicated for the diagnosis or screeningof diabetes or for neonatal use.The BGM009 Blood Glucose Test Strips are to be used with the BGM009Blood Glucose Meter to quantitatively measure glucose in capillary wholeblood taken from fingertips, palm, or forearm.
Comparison ofTechnologicalCharacteristics:	The BGM009 meter has been modified relative to the predicate by minorchanges in external design and modifications of the test strip holder tosupport the hematocrit compensation feature. Meter software has beenaugmented to support the hematocrit compensation feature. The BGM009test strip has been modified relative to the predicate by minor changes inchemistry, alteration of electrode tracks to support 6 calibration codes, andaddition of electrode tracks to support the hematocrit compensation feature.
Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, test stripholder reliability testing, battery life verification, drop testing, disinfectionperformance (robustness of meter to multiple cleanings and disinfections),software verification and validation, and linearity testing with validation ofLo/Hi detection, temperature and humidity testing, sample volumeverification, precision testing, interferences testing, altitude testing,qualification of control solutions, hematocrit performance testing,disinfection testing with recommended disinfectant wipes was done using ananimal virus test model. Results demonstrate substantial equivalence to thepredicate system.
Clinical Testing	An accuracy study was conducted with home users, including evaluation ofease of use and ease of understanding of the user manual. Resultsdemonstrate substantial equivalence to the predicate system.
Conclusion:	Clinical and non-clinical testing demonstrated that the BGM009 systemperforms in a substantially equivalent manner to that of the predicate. We
, conclude that the BGM009 system is substantially equivalent to the predicate '
' system.

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510(k) Summary (Continued)

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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.