AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM by APEX BIO TECHNOLOGY CORP

The AutoSure Voice 3 Plus 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. The meter includes voice functionality to assist visually impaired users. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus 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 AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Description

The AutoSure Voice 3 Plus blood glucose meter and AutoSure Plus test strips are used for testing of blood glucose by self-testers at home. Contrex Plus III Glucose Control Solutions are used for quality control testing of the system.

AI/ML Overview

The provided text is a 510(k) Summary for the AutoSure Voice 3 Plus Blood Glucose Monitoring System. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed clinical study results with performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or information about MRMC studies, standalone performance, training sets, or how ground truth was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AutoSure Voice II Plus Blood Glucose Monitoring System) based on changes in button relocation and the use of the same test algorithm and test strips.

Here's an analysis based only on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the AutoSure Voice 3 Plus system uses the same test algorithm and test strips as the predicate meter (AutoSure Voice II Plus Blood Glucose Monitoring System). This implies that the performance expectations align with those of the predicate device. However, the specific acceptance criteria and numerical performance metrics for either the predicate or the new device are not provided in this summary.

The document mentions:

"EMC & Electrical Safety and linearity testing. Results demonstrate substantial equivalence to the predicate system."
"A user survey shows substantial equivalence in ease-of-use after the relocation of the operation buttons."
"Testing demonstrated that the AutoSure Voice 3 Plus system performs in a substantially equivalent manner to that of the predicate."

Therefore, a table cannot be constructed with specific metrics based on the provided text. The general "acceptance criterion" appears to be "substantial equivalence" to the predicate device.

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

Test Set Sample Size: Not specified. The document mentions a "user survey" for ease-of-use but does not provide details on the number of participants.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The submitter is from China (Taiwan), but the location of the clinical testing (user survey) is not mentioned. The nature of the user survey (retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable / Not Specified. For a blood glucose monitoring system, the "ground truth" for glucose levels is typically established by a laboratory reference method, not by human experts interpreting data or images. The document does not describe any expert involvement in establishing ground truth for glucose measurements or for the user survey.

4. Adjudication Method for the Test Set:

Not Applicable / Not Specified. As there's no mention of expert ground truth establishment, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. An MRMC study is typically performed for diagnostic imaging devices where multiple readers interpret cases. This device is a blood glucose monitoring system, which does not involve human readers interpreting images.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, implicitly. The device itself is designed to provide a quantitative measurement of glucose. The "test algorithm" is key to this standalone performance. The document states that the new device uses the "same test algorithm" as the predicate. The "EMC & Electrical Safety and linearity testing" would also fall under standalone performance testing. However, specific performance results (e.g., accuracy, precision) of this standalone algorithm are not provided in this summary.

7. The Type of Ground Truth Used:

Not explicitly stated in detail, but for a blood glucose monitoring system, the ground truth for glucose measurements would typically be established by a laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory instrument). The summary does not provide details on the reference method used or how it was applied during any performance studies. For the "user survey," the ground truth was "user satisfaction/ease-of-use."

8. The Sample Size for the Training Set:

Not Applicable / Not Specified. For a traditional blood glucose meter, there isn't typically a "training set" in the sense of machine learning. The algorithm is based on electrochemical principles and calibration.

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

Not Applicable. As there's no distinct training set mentioned in the machine learning context, this question isn't relevant to the information provided.

In summary, the provided 510(k) Summary focuses on demonstrating substantial equivalence primarily through design changes (button relocation) and the continuity of the core technology (same algorithm and test strips). It lacks granular detail on performance criteria, clinical study methodology, and specific results often found in submissions for devices with more complex diagnostic algorithms or imaging components.

Summary

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

K120649

JUL

6 510(k) Summary

2017

: : : : :

Submitter:	Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
Contact Person:	Lisa LiuAssistant Manager of Quality Assurance DepartmentApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: lisaliu@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	March 1, 2012
Trade Names:	AutoSure Voice 3 Plus Blood Glucose Monitoring SystemAutoSure Plus Blood Glucose Test Strips
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW
Predicate Device:	AutoSure Voice II Plus Blood Glucose Monitoring System (K113098)AutoSure Plus Blood Glucose Test Strip (K113098 )
Device Description:	The AutoSure Voice 3 Plus blood glucose meter and AutoSure Plus teststrips are used for testing of blood glucose by self-testers at home.Contrex Plus III Glucose Control Solutions are used for quality controltesting of the system.

. . . . . . . . . .

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

510(k) Summary (Continued)

. . . . . . .

Intended Use:	The AutoSure Voice 3 Plus Blood Glucose Monitoring System is intendedfor the quantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips, forearm, or palm. The meter includesvoice functionality to assist visually impaired users. It is indicated for layuse by people with diabetes as an aid to monitoring levels in DiabetesMellitus and should only be used by a single patient and it should not beshared. It is not indicated for the diagnosis or screening of diabetes or forneonatal use.
	The AutoSure Plus Blood Glucose Test Strips are to be used with theAutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measureglucose in capillary whole blood taken from fingertips, palm, or forearm.They are not indicated for the diagnosis or screening of diabetes or forneonatal use.
Comparison ofTechnologicalCharacteristics:	The AutoSure Voice 3 Plus system has been modified relative to thepredicate by relocating the 3 operating buttons from the front to the side ofthe meter. The AutoSure Voice 3 Plus meter uses the same test algorithm andtest strips as the predicate meter. Both systems use Contrex Plus III controlsolutions.
Non-ClinicalTesting:	EMC & Electrical Safety and linearity testing. Results demonstratesubstantial equivalence to the predicate system.
Clinical Testing	A user survey shows substantial equivalence in ease-of-use after therelocation of the operation buttons.
Conclusion:	Testing demonstrated that the AutoSure Voice 3 Plus system performs in asubstantially equivalent manner to that of the predicate. We conclude thatthe new system is substantially equivalent to the predicate device.

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

and the comments of the comments of

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

10903 New Hampshire Avenue Silver Spring, MD 20993

Apex Biotechnology Corporation c/o Lisa Liu No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, China (Taiwan) 30078

6 2012 JUL

K120649 Re:

K120649
Trade Name: AutoSure 3 Plus Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA Dated: June 7, 2012 Received: June 8, 2012

Dear Ms. Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device
tion the We have reviewed your Section 310(ts) premium is substantially equivalent (for the referenced above and have delemined the be readly marketed predicate devices marketed in
indications for use stated in the 100 100 100 100 100 100 100 100 100 100 indications for use stated in the enclosures to regars ment date of the Medical Device interstate commerce prior to Way 20, 1970, the cities with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions of Amendments, or to devices that nave been results approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do require approval of a premarket the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (PMA). Tou may, marcels, increase of the Act include controls provisions of the Act. The general connell provides, good manufacturing practice, a
requirements for annual registration, listing of devices in requirements for annual regionalism, and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affective If your device is classified (sec additional controls. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations (PMA), it may be subject to such adultions controls. Bread Regulations (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Part your device can be found in Title 21, Code of Pederal Rogalated (1 (1) 7)
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 Please be advised that FDA's Issualite of a substitutions with other requirements
mean that FDA has made a determination administered by other Federal agencies. mean that FDA has made a decimination indivise ed by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with all the Act Stequitements, and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and go and listing (21 CFR Part 807); labeling (21 CFR 803); and good reporting (reporting of medical device-related adverse overse (OS) regulation (21 CFR Part 820).

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

· Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you attire 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/Medical

Devices/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 I ou may 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/Resourcesfor You/Industry/default.htm

Sincerely yours,

N.
K. Jain, Ph.D.

Counney H. Lias, Ph.D. Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

5 Indications for Use Statement

510(k) Number (if known):

Device Name: AutoSure Voice 3 Plus Blood Glucose Monitoring System

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K12 0649

Page I of 1

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.