The GLUCOLAB™ Diabetes Monitoring System and EOCENE™ System is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCQLAB™ System and EOCENE'M System is not to be used for diagnosis, screening of diabetes or for neonatal use. The GLUCOLAB™ System and EOCENE™ System are for testing outside the body (in vitro diagnostic use only).

Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.

GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly

Device Description

Data transmitted by the Eocene™ system is available online for you or your designed healthcare professionals to review within the Eocene Secure website. To register your Eocene™ cradle for use with the Eocene systems, contact the dealer you purchased your device from or visit www.eocenesystems.com for more information. For best results. follow the daily testing frequency prescribed by your and upload your data at least once a week or as indicated by your provider.

The Eocene™ system may be used with GlucoLab™ or Eclipse™ Diabetes Monitoring Systems.

This Eocene™ System is used with the GLUCOLAB™ Diabetes Monitoring System. It is composed of the Eocene cradle, DC 5V Adaptor, and phone line.

It allows to use the phone line to upload GlucoLab™ data to a database server.

AI/ML Overview

This document describes the Eocene™ Glucose Telecommunication system, an accessory device that allows the GLUCOLAB™ Diabetes Monitoring System to upload data via a phone line to a database server. It is important to note that the primary glucose monitoring system itself (GLUCOLAB™) is described as operating under the same technological characteristics as its predicate device (K051285). The Eocene™ system's function is specifically data transmission, not the direct measurement of glucose.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The acceptance criteria are implicitly defined by the "pre-determined Pass/Fail criteria" for various tests. The device's performance is reported as meeting these criteria.

Acceptance Criteria Category	Reported Device Performance
Software Requirement Specifications	Passed all tests based on pre-determined Pass/Fail criteria.
Product Requirement Specifications	Passed all tests based on pre-determined Pass/Fail criteria.
User Interface Requirement Specifications	Passed all tests based on pre-determined Pass/Fail criteria.
Functionality	Established
Reliability	Established

Study Details:

This submission focuses on the Eocene™ Glucose Telecommunication system, which is a data transmission accessory for a blood glucose monitoring system. The study described is non-clinical verification and validation of this accessory, rather than a clinical efficacy study of a glucose meter itself.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or glucose readings. The "test set" refers to the verification and validation activities conducted on the Eocene™ system itself, likely involving various software and hardware tests.
- Data Provenance: Not applicable in the context of clinical patient data. The testing was conducted internally by the manufacturer (Infopia Co.,ltd.) and is described as "non-clinical."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would relate to the correct functioning of the telecommunication system, not clinical interpretations. The "Pass/Fail criteria" for the software, product, and user interface specifications would have been established by the manufacturer's engineering and quality teams.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for clinical endpoints requiring expert consensus. The non-clinical testing of the Eocene™ system would follow standard engineering verification and validation protocols with internal review.
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:
- No. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting cases. The Eocene™ system is a data telecommunication accessory.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "Performance Data" section describes "Verification, validation and testing activities... to establish the performance, functionality and reliability characteristics of the Eocene 100 Glucose Telecommunication." This non-clinical testing evaluates the device's ability to transmit data according to its specifications, which is an "algorithm only" or system-only performance assessment in a controlled environment. Human interaction would be in operating the system and reviewing test results, but not in interpreting patient data in a clinical context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the Eocene™ system refers to its ability to correctly and reliably transmit data. This would be established by comparing the transmitted data against the original data from the GlucoLab™ system to ensure integrity and accuracy of transmission. It's essentially a functional validation to ensure data is transferred without corruption.
The sample size for the training set:
- Not applicable. As a non-clinical data transmission device, there would not be a "training set" in the sense of machine learning or AI models. Development would involve iterative testing and refinement, but not a distinct training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable for the reasons mentioned above.

Summary

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510(k) Summary

EXHIBIT #1

109071 2

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. The assigned 510(K) Number is not applicable.

Date: March , 2009

OCT - 2 2009

1. Submitter:

Submitted by:	Infopia Co.,ltd.#1603, Dongil Technotown A Bldg.,889-3, Kwanyang2-Dong, Dongan - GuAnyang, Kyunggi 431-716, KoreaPhone +82-31-423-6170Fax+82-31-423-6171
Contact:	Bryan OhPhone: 1-321-267-9911Fax: 1-321-267-5582

2. Device:

Propriety Name	Eocene™ Glucose Telecommunication system
	Blood glucose monitoring system
Common Name	Data Management system; Accessory to MedicalDevice
Classification Name:	System, test, blood glucose, over the counter
	Glucose Oxidase
	Single (specified) analyte controls
	Physiological signal transmitters and receivers
	Class II
Classification:	21 CFR Part 862.1345,
	21 CFR Part 862.1660
	21 CFR Part 870.2910
Product Code:	NBW, JQP

3. Predicate Device:

GlucoLab™ Blood Glucose Monitoring System(Infopia co., Ltd.) K051285

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Description: 4.

The Eocene™ system may be used with GlucoLab™ or Eclipse™ Diabetes Monitoring Systems.

5. Indications for use:

The GLUCOLAB™ Diabetes Monitoring System and EOCENE " System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCOLAB " System and EOCENE "" System provide plasma equivalent results. The GLUCOLABTM System and EOCENE 100 System is not intended to be used with neonatal blood samples. The GLUCOLAB™ System and EOCENE™ System is for testing outside the body (in vitro diagnostic use onlv).

Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.

GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results.

Control Solutions are sold separately.

Comparison of Technological Characteristics with Predicate: 6.

The GLUCOLAB™ Diabetes Monitoring System still operates under the same technological characteristics as the predicate device cleared under K051285.

This Eocene™ System is used with the GLUCOLAB™ Diabetes Monitoring System. It is composed of the Eocene cradle, DC 5V Adaptor, and phone line.

Confidential Infopia Co., Ltd.

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It allows to use the phone line to upload GlucoLab™ data to a database server. This does not affect to the safety and effectiveness of the GlucoLab data.

Performance Data: 7.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Eocene 100 Glucose Telecommunication. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from the risk analysis. The device passed all of the tests based on pre-determined Pass/Fail criteria.

8. Conclusion

The data from non clinical tests show that the use of the Eocene™ Glucose Telecommunication system is as safe and effective as the legally marketed predicate device (GlucoLab' "").

Therefore we conclude that the Eocene™ Giucose Telecommunication system is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing to the left and has its head turned towards the viewer.

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

Infopia Co., Ltd c/o Maria F Griffin, Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

OCT - 2 2009

Re: K090712

Trade/Device Name: Eocene System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: Sep 2, 2009 Received: Sep 3, 2009

Dear: Ms. Griffin,

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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Page 2

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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EXHIBIT #3

Indications for Use

Page 1 of 1

510(k) Number (if known): K090712

Device Name : GLUCOLAB™ Diabetes Monitoring System and EOCENE™ System

Indications For Use:

Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.

GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use × AND/OR (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

Division sign

Office of In Vitro Diagnostic Device Evaluation and Safely

510(k) K090712

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.