The eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, eBsensor Blood Glucose Monitoring System, eB-G only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.

AI/ML Overview

The Visgeneer eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a study beyond referring to compliance with "Guidance Document for In Vitro Diagnostic Test System." Therefore, a definitive table of acceptance criteria and reported performance cannot be generated directly from the given text.

However, the document states that "A claim of substantial equivalence is made to LIFESCAN, INC. - One Touch Ultra Blood Glucose Monitoring System (K043197)." This implies that the eBsensor system's performance is expected to be comparable to or within acceptable limits of the predicate device.

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

Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical data (test set). It only mentions that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. For blood glucose meters, adjudication of expert opinions is not typically relevant as the ground truth is established by a more precise laboratory method.

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

No information is provided about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any mention of human readers improving with or without AI assistance. This type of study is not typically relevant for a blood glucose monitoring system, which measures a quantitative biomarker directly.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The eBsensor system is a standalone diagnostic device. The performance data would inherently be "algorithm only" as it provides a direct measurement from a blood sample. The document does not detail the specific standalone performance study, but the substantial equivalence claim implies that its standalone performance meets regulatory expectations compared to the predicate device.

7. Type of Ground Truth Used

The type of ground truth used would almost certainly be a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer or a similar highly accurate clinical chemistry instrument). This is standard practice for validating blood glucose monitoring systems. The document does not explicitly state the method, but it is implied by the nature of the device.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is typical for a device using an electrochemical biosensor. While the sensor and algorithm would have been developed and calibrated with various samples, the 510(k) summary focuses on the validation of the final product with clinical data, usually referred to as the "test set" in this context even if not explicitly named.

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

As no training set is described in the document, there is no information on how its ground truth was established. If there were calibration or development data, the ground truth would also have been established using a laboratory reference method.

Summary

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KO62555

31 .- 2. No.83, Sec. 2. Gongdao 5th Rd., Hsinchu City 300, Taiwan Tel : 886-3-5160111 Fax : 886-3-5160161 Http://www.visgeneer.com.tw Mail: vis@visgeneer.com.tw

DEC 2 7 2006

510(K) Summary of Safety and Effectiveness II.

(Per 21 CFR 807.92)

2.1. General Information Establishment

VISGENEER, INC. . Manufacturer: 3F-2, No.83, Sec. 2, Gongdao 5th Road, Hsinchu City, Taiwan, 30070 . Address: 트 Registration Number: 3005644014 Contact Person: Dr. Jen, Ke-Min Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax) . Date Prepared: August 25, 2006 Device . Proprietary Name: eBsensor Blood Glucose Monitoring System, eB-G ● Common Name: Blood Glucose Monitoring System ● Classification Name: SYSTEM, TEST, BLOOD GLUCOSE,
OVER THE COUNTER, Class II,

2.2. Safety and Effectiveness Information

. Predicate Device:
Claim of Substantial Equivalence (SE) is made to LIFESCAN, INC. - One Touch Ultra Blood Glucose Monitoring System (K043197)
. Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, eBsensor Blood Glucose Monitoring System, eB-G only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.

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� Intended Use:

The eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Synopsis of Test Methods and Results .

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

● Substantial Equivalence (SE)

A claim of substantial equivalence is made to LIFESCAN, INC. -- One Touch Ultra Blood Glucose Monitoring System (K043197). Both of them have the same working principle and technologies. The differences are electric voltage, dimensions of the unit and strip, weight. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.

signature

Ke-Min Jen, Dr. Official Correspondent for VISGENEER, INC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three overlapping profiles, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Jen, Ke-Min Official Correspondent 3F-2, No.83, Sec.2, Gongdao 5th Road Hsinchu City, Taiwan 30070

DEC 2 7 2006

Re: K062555

Trade/Device Name: eBsensor Blood Glucose Monitoring System, Eb-G Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 12, 2006 Received: December 15, 2006

Dear Dr. Jen:

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 (1) The general controls provisions of the Act include requirements for annual registration, l'isti 1 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 revire, 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 Degister.

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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VISGENEER INC.

3F .- 2, No 83, Sec. 2, Gongdao 5th Rd., Hsinchu City 300, Taiwan Tel : 886-3-5160111 Fax : 886-3-3160161 Hitp://www.visgeneer.com/w Mail: vis a visgeneer com.tu

Indications for Use

510 (K) Number ( If Known ): ___ K062555

Device Name: eBsensor Blood Glucose Monitoring System, eB-G

Indications for Use:

AND/OR Over-The-Counter Use __ Prescription Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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 Sign-Off

ffice of in Vitro Diag

510(k) *012555

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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.