The ReliOn Premier BLU Blood Glucose Monitoring System is comprised of the ReliOn Premier BLU Blood Glucose Meter and the ReliOn Premier Blood Glucose Test Strips.

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The ReliOn Premier BLU 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 to monitor the effectiveness of diabetes control.

The system is intended to be used by a single person and should not be shared.

The system is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Device Description

The ReliOn Premier BLU Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology that the meter communicates to smartphones wirelessly. The ReliOn Premier BLU BGMS has a target range indicator that upon consulting with a healthcare professional, users have the option to activate the function that displays blood glucose measurement results on a colored backlight display. By default, this indicator function is set to OFF. However, it is recommended that users consult with a healthcare professional to determine the target range for their individual needs.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the ReliOn Premier BLU Blood Glucose Monitoring System, comparing it to a predicate device. The information required for a comprehensive study description, such as that for an AI-based medical device, is not provided in this document. This submission focuses on engineering modifications of an existing device and its equivalence to a predicate, not on a new algorithm's performance or a comparative effectiveness study involving human readers and AI.

Therefore, many of the requested details, particularly regarding AI-specific studies (e.g., MRMC studies, standalone algorithm performance, training data details, expert consensus for ground truth on AI models), are not applicable to this submission.

However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed.

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

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision) or detailed reported device performance data as would be seen for a new algorithm study. Instead, it describes equivalence to a predicate device and mentions that the non-clinical tests indicated the device "performed as intended and fulfilled the specifications."

The key performance characteristics are compared to the predicate device:

Feature	Predicate device CareSens N Premier BT (K170614)	Candidate device ReliOn Premier BLU Blood Glucose Monitoring System	Performance (as stated)
Measurement range	20-600 mg/dL	Same	Same
Sample size	Minimum 0.5 µL	Same	Same
Test time	5 seconds	Same	Same
Sample type	Fresh capillary whole blood	Same	Same
Calibration	Plasma-equivalent	Same	Same
Battery life	1,000 tests	Same	Same
Power	Two 3.0V lithium batteries (disposable, type CR2032)	Same	Same
Memory	1,000 test results	Same	Same
Target range indicator	N/A	Red, Green, Blue colored screens for below, within, and above target range.	New feature added; functionality verified.

Acceptance Criteria (Implied from the document):
The acceptance criteria are implicitly that the ReliOn Premier BLU Blood Glucose Monitoring System demonstrates "substantial equivalence" to the predicate device, CareSens N Premier BT Blood Glucose Monitoring System (K170614), and that the modifications (target range function, LCD, PCB, labeling) perform as intended and fulfill specifications. Specific quantitative criteria for accuracy, precision, or other performance metrics (e.g., ISO standards for blood glucose meters) are not detailed in this summary.

Reported Device Performance:
"The results of these tests indicated that the ReliOn Premier BLU Blood Glucose Monitoring System, with the proposed changes outlined in this document, performed as intended and fulfilled the specifications."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any test set (e.g., number of subjects or samples used in the non-clinical tests like software function, power consumption, etc.).
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified for the non-clinical tests mentioned. Given the manufacturer's location, testing likely occurred in South Korea, but this is not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The ground truth for a blood glucose monitoring system is typically established against a laboratory reference method (e.g., YSI analyzer) for glucose concentration, not by human experts interpreting results. The document does not mention any expert involvement in establishing ground truth for the non-clinical tests.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in imaging or clinical trial contexts. This document describes non-clinical engineering and performance tests for a blood glucose meter.

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 is not applicable. This document describes a continuous glucose monitoring system, not an AI imaging or diagnostic tool that assists human readers. No MRMC study was conducted or mentioned.

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

This is not applicable in the context of an AI algorithm. This device is a measurement system; its "standalone performance" refers to its accuracy in measuring blood glucose, which is evaluated through specific performance studies (e.g., accuracy against a reference method, precision studies). While these types of studies were undoubtedly performed as part of the overall testing (likely consistent with ISO 15197 for blood glucose monitoring systems, though not explicitly stated in this summary), the details of such quantitative performance studies are not provided in this 510(k) summary. The summary only broadly states that the device "performed as intended and fulfilled the specifications."

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

For a blood glucose monitoring system, the ground truth for glucose measurements is typically established using a laboratory reference method (e.g., YSI glucose analyzer) on venous plasma or serum samples. This is a highly accurate chemical measurement. The document does not explicitly state the ground truth method but this is standard practice for blood glucose meter validation.

8. The sample size for the training set

This is not applicable. This document describes a medical device (blood glucose meter), not an AI model that requires a training set.

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

This is not applicable. As above, this is an engineering device, not an AI model with a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

August 10, 2023

i-SENS, Inc. H.S. Yoo Regulatory Affairs Specialist /Manager 43, Banpo-Daero 28 Gil Seocho-Gu, Seoul 06646 South Korea

Re: K230625

Trade/Device Name: ReliOn Premier BLU Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 12, 2023 Received: July 14, 2023

Dear H.S. Yoo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Joshua Balsam -S

Joshua M. Balsam, PhD. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230625

Device Name

ReliOn Premier BLU Blood Glucose Monitoring System

Indications for Use (Describe)

The ReliOn Premier BLU Blood Glucose Monitoring System is comprised of the ReliOn Premier BLU Blood Glucose Meter and the ReliOn Premier Blood Glucose Test Strips.

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The system is intended to be used by a single person and should not be shared.

The system is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

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)

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Image /page/3/Picture/0 description: The image shows the logo for i-sens. The logo is in blue, with a green dot above the "i". The text is in a sans-serif font and is slightly italicized. The logo is simple and modern.

i-SENS, Inc. 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, Korea, 06646 Tel.: +82-2-916-6191 | Fax.: +82-2-942-2514 | www.i-sens.com

K230625 510(k) Summary

Prepared in accordance with the requirements of 21 CFR 807.92 to provide an understanding of the basis for a substantial equivalence determination.

Date prepared: July 28, 2023

1. Applicant Information

Name	: i-SENS, Inc.
Address	: 43, Banpo-daero 28-gil, Seocho-gu, Seoul, South Korea 06646
Applicant ContactCorrespondent	: H.S. Yoo (Regulatory Affairs Specialist / Manager)i-SENS, Inc.,43, Banpo-daero 28-gil, Seocho-gu, Seoul, South Korea 06646
E-mail	: registration@i-sens.com

2. Medical Device Information

Device Name	: ReliOn Premier BLU Blood Glucose Monitoring System
Common name	: Blood Glucose Monitoring System
Regulation number	: 21 CFR 862.1345
Class	: Class II
Product Code	: NBW
Submission Type	: Special 510(k)

3. Predicate Device Information

CareSens N Premier BT Blood Glucose Monitoring System (K170614)

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4. Device Description

5. Intended Use

The ReliOn Premier BLU Blood Glucose Monitoring System is comprised of the ReliOn Premier BLU Blood Glucose Meter and the ReliOn Premier Blood Glucose Test Strips.

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The system is intended to be used by a single person and should not be shared.

The system is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Feature	Predicate deviceCareSens N Premier BT(K170614)	Candidate deviceReliOn Premier BLU BloodGlucose Monitoring System
Measurement range	20-600 mg/dL	Same
Sample size	Minimum 0.5 µL	Same
Test time	5 seconds	Same
Sample type	Fresh capillary whole blood	Same
Calibration	Plasma-equivalent	Same
Battery life	1,000 tests	Same
Power	Two 3.0V lithium batteries(disposable, type CR2032)	Same
Memory	1,000 test results	Same
Target range indicator	N/A	Red, Green, Blue coloredscreens for below, within, andabove target range.

6. Technological characteristics compared to the Predicate device

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Image /page/5/Picture/0 description: The image shows the logo for i-sens. The logo is composed of the letter "i" in blue, with a green dot above it. The word "sens" is also in blue and is connected to the "i". The logo is simple and modern.

7. Modification from the predicate device

The modifications made are as follows:

The inclusion of a target range function with the red, green, and blue backlight screen. a.
Change in the LCD specifications, which consists of three backlight colors and the addition of b. C-Clips for connecting to the PCB.
Amendments to the PCB to enable connection of the LCD to other components of the blood C. glucose meter.
Updates to the labeling to feature information on the target range function and the method for d. setting the target range.

8. Performance Testing (Non-Clinical Testing)

The verification and validation activities carried out based on the adoption of the target range function included the following tests: Software function tests, power consumption, battery lifetime, memory, EMC, electrical safety, and human factors study.

The results of these tests indicated that the ReliOn Premier BLU Blood Glucose Monitoring System, with the proposed changes outlined in this document, performed as intended and fulfilled the specifications.

9. Conclusion

The verification and validation results demonstrated that the ReliOn Premier BLU Blood Glucose Monitoring System has been shown to be substantially equivalent to the predicate device, CareSens N Premier BT Blood Glucose Monitoring System (K170614).

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.