The Element™ V Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, palm, hand, upper-arm, forearm, calf, and thigh. The Element™ V Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ V Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Element™ V test strips are for use with the Element™ V meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the finger, palm, hand, upper-arm, forearm, calf and/or thigh.

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

This meter contains some speaking functions but has not been validated for use by the visually impaired. By adding the voice function, users can hear test results, setting conditions and warning messages (errors) while performing the test. This added function is intended to aid users for their convenience.

Device Description

The Element™ V Blood Glucose Monitoring System consists of the meter, test strips and control solutions (Level 1, Level 2 and level 3). 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

The provided text contains limited information about the acceptance criteria and details of the clinical study, making it challenging to extract all the requested information comprehensively. However, I will do my best to present the available details in the requested format.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages within certain glucose ranges) for the Element™ V Blood Glucose Monitoring System. It generally states:

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy / Substantial Equivalence to Predicate Device	"Test results showed substantial equivalence."
"device is as safe, as effective and performs as well as the legally marketed predicate device"
Performance, Functionality, Reliability	"The device passed all of the tests based on pre-determined Pass/Fail criteria."
Disinfection Efficacy	"Validated demonstrating complete inactivation of live virus" with CaviWipes.
Durability after Disinfection	"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 the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size (Clinical): The document states "The clinical performance evaluation... was conducted for purpose of validating the consumer use for the accuracy." It does not specify the number of participants or samples used in this clinical accuracy study.
Data Provenance: Not explicitly stated, but the applicant company (Infopia Co., Ltd.) is based in Korea. It's common for initial studies to be conducted in the country of origin. The study is referred to as a "clinical performance evaluation," which typically implies a prospective design for validating accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by a laboratory reference method, not by human experts interpreting results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret data (e.g., imaging studies). For objective measurements like blood glucose, accuracy is determined by comparison to a reference standard, not by expert consensus on the device's reading.

5. 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

This information is not applicable. The Element™ V Blood Glucose Monitoring System is a standalone device for quantitative glucose measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting output or an MRMC study design.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the primary clinical performance evaluation described is for the standalone device (Element™ V Blood Glucose Monitoring System) measuring glucose. Its accuracy is evaluated without a "human-in-the-loop" to interpret the results beyond the user following instructions to obtain a reading. The voice function is an aid for convenience, not an interpretation element.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is universally established by laboratory reference methods (e.g., YSI analyzer, or other highly accurate, traceable laboratory-grade glucose measurement devices). It would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. The text focuses on the clinical performance evaluation for validation. It does not mention details about algorithm development or training sets, which are more common for AI/ML-based devices.

9. How the ground truth for the training set was established

This information is not provided and likely not applicable in the context of this device's technology. As it's an electrochemical glucose meter, the "training set" concept (as understood in machine learning) is not directly relevant to its core operational principle. If any internal calibration or algorithm adjustments were made during development, they would typically rely on comparisons to laboratory reference methods, but this is not detailed.

Summary

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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: _03/10/2014

1. Submission Applicant / Submitter

Infopia Co., Ltd.

· 891 Hogye-dong, Dongan-Gu, Anyang, Kyunggi, 431-080, Korea Phone: +82-31-460-0300 Fax: +82-31-460-0401

2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

· Trade Name: Element™ V 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 TM plus Blood Glucose Test System (K 103021), Infopia Co., Ltd.

1. Description:
  The Element™ V Blood Glucose Monitoring System consists of the meter, test strips and control solutions (Level 1, Level 2 and level 3). 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.

6. Indications for use:

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1. Comparison to the Cleared Device
  The modifications are the changes in the strip size, the material of the test strip vial, the test strip quantity in the vial, the appearance of the meter housing and the strip cover, and also adding an error message.

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,
· adopts the same use environment and calibration method.

8. Performance Data

Clinical: The clinical performance evaluation using the Element TM V Blood Glucose Monitoring System was conducted for purpose of validating the consumer use for the 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 " V 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.

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9. Conclusion

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

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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

INFOPIA CO., LTD C/O PRISCILLA CHUNG 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92833

April 18, 2014

Re: K132406

Trade/Device Name: Element V Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: March 10, 2014 Received: March 14, 2014

Dear Ms. Priscilla 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 requirements for annual registration. Ilisting 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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Page 2-Ms. Priscilla Chung

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/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/Salety/ReportalProblem/dcfault.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.

Sincercly yours.

Katherine Serrano -S

For : 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

510(k) Number (if known) K132406

Device Name

Element™ V Blood Glucose Monitoring System

Indications for Use (Describe)

The Element™ V Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, palm, hand, upper-arm, calf, and thigh. The Element™ V Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ V Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Element™ V control solutions are for use with the Element™ V test strips to check that the meter and test strips are working together properly and the test is performing correctly,

This meter contains some speaking functions but has not been validated for use by the visually impaired. By adding the voice function, users can hear test results, setting conditions and warning messages (erors) while performing the test. This added function is intended to aid users for their convenience.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Stavce Beck -S

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

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.