The Element The Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element 101 Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element ™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element The Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.

The Element TM Test Strips are for use with the Element M Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The Element ™ control solutions are for use with the Element ™ Blood Glucose Monitoring system to check that the meter and the test strips are working together properly and the test is performing correctly.

Device Description

The Element™ Blood Glucose Monitoring System consists of the meter, test strips and control solutions (low, normal and high levels). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Element™ Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format with specific thresholds (e.g., "X% of results within Y% of reference"). Instead, it broadly states that the device passed "pre-determined Pass/Fail criteria" and showed "substantial equivalence" to the predicate device. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197 for accuracy. However, this specific 510(k) summary only provides a high-level qualitative description.

Acceptance Criteria Category	Reported Device Performance
Clinical Performance	"Test results showed substantial equivalence [to the predicate device]."
Non-clinical Performance	"The device passed all of the tests based on pre-determined Pass/Fail criteria."
Disinfection Study	"complete inactivation of live virus" with CaviWipes; "no change in performance or in the external materials of the meter and the lancing device after 1,095 cleaning/disinfection cycles."

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

Sample Size for Test Set: The document does not specify the exact sample size used for the clinical performance evaluation (test set). It only states that a "clinical performance evaluation using the Element™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy."
Data Provenance: Not explicitly stated (e.g., country of origin). The submission sponsor is Infopia Co.,Ltd. from Korea, which might suggest the studies were conducted there, but this is not confirmed. The document only mentions the "clinical performance evaluation." The type is prospective, as it's a "clinical performance evaluation" rather than an analysis of existing data.

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

This information is not provided in the given 510(k) summary. For blood glucose monitoring systems, the "ground truth" (reference measurements) would typically come from a laboratory reference method, not human expert consensus like in imaging studies.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret results and need to reach consensus, often in imaging or pathology. For a blood glucose monitoring system, the "ground truth" comes from a reference laboratory method, not from subjective human interpretation.

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

Was it done? No, a MRMC comparative effectiveness study was not conducted. This type of study assesses how human readers perform with and without an AI CAD system, which is not relevant for a blood glucose monitoring device.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no such study was performed or is relevant to this device type.

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

Was it done? Yes, a standalone performance evaluation was conducted. The "clinical performance evaluation" and "non-clinical performance evaluation" assess the device's accuracy and functionality in its intended use, typically without human interpretation influencing the measurement result itself. The device itself is the "algorithm" that measures glucose.

7. Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., YSI analyzer, hexokinase method). While the document states "professional accuracy" was validated, it does not explicitly name the specific reference method used.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an AI/ML algorithm. This device is a traditional in vitro diagnostic device, not an AI/ML powered one, so the concept of a "training set" for an algorithm to learn from is not applicable here.

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

As there is no mention of a training set for an AI/ML algorithm, this information is not applicable and not provided.

Summary

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K113670
MAY - 8 2012

510(k) Summary

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 04/27/2012

Submission Sponsor

	Submitter
NameAddress	Infopia Co.,Ltd.891 Hogye-dong, Dongan-Gu, Anyang, Kyunggi,431-080, Korea
Phone	Phone: +82-31-460-0300
Fax	Fax: +82-31-460-0401

Submission Correspondent

LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

Device

· Trade Name: Element™ Blood Glucose Monitoring System

· Classification Name: Glucose test system, Quality control material (assayed and unassayed)

· Classification regulation: 21 CFR Part 862.1345, 21 CFR Part 862.1660

· Product Code: NBW, CGA, JJX

Predicate Device:

Element 100 plus Blood Glucose Test System (K103021), Infopia Co., Ltd.

Description:

Indications for use:

· Element™ Blood Glucose Monitoring System (For single patient-home use)

510(k) Submission

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The Element ™ Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element The Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element ™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element ™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.

The Element ™ Test Strips are for use with the Element™ Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh,

The Element TM control solutions are for use with the Element ™ Blood Glucose Monitoring system to check that the meter and the test strips are working together properly and the test is performing correctly.

Comparison to the Cleared Device

The battery type, the location of the display icons, the raw material of the LCD, and the dimension of the meter have been changed, and the voice function has been removed. Other than these modifications, the modified meter has the following similarities to the cleared device:

· has the same intended use,
· uses the same operating principle,
· incorporates the same materials.
· adopts the same use environment and calibration method, and has the same shelf life.

Performance Data

Clinical: The clinical performance evaluation using the Element ™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Element ™ Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and the lancing device after 1,095 cleaning/disinfection cycles designed to simulate 3 years of device use.

510(k) Submission

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Conclusion

The conclusion drawn from the clinical and nonclinical tests is that the Element ™ Blood Glucose Monitoring System is as safe, as effective and performs as well as the legally marketed predicate device, Element TM plus Blood Glucose Test System (K103021).

510(k) Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or other bird with outstretched wings.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

MAY - 8 2012

Infopia Co., Ltd. c/o Priscilla Chung 951 Starbuck St, Unit J Fullerton, CA 92833

K113670 Re:

Trade Name: Element blood glucose monitoring system Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: April 6, 2012 Received: April 12, 2012

Dear Ms. Chung:

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 1 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 11 Jou abilie 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 Biometrig'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 Tou 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/ResourcesforYou/Industry/default.htm

Sincerely yours,

Couriney 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

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Indication for Use

510(k) Number (if known):

Device Name: Element The Blood Glucose Monitoring System

Indication For Use:

Prescription Use _ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K113670

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.