The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic 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. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Device Description

The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ReliOn™ Premier Classic Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only touches upon the regulatory approval and indications for use. It does not include a table explicitly stating acceptance criteria or detailed performance results against those criteria. Clinical performance data, often presented in tables conforming to ISO standards (e.g., ISO 15197 for blood glucose monitoring systems), would typically be found in the full 510(k) submission but are not present in this summary.

To illustrate what such a table would look like for a blood glucose monitoring system, I'll describe typical acceptance criteria based on ISO 15197 (a common standard for such devices), and then indicate that the provided document does not contain the performance data.

Hypothetical Table (Based on typical ISO 15197 standards; performance data not in document):

Acceptance Criteria (ISO 15197:2013)	Reported Device Performance (Not in document)
Accuracy (System Accuracy Evaluation):
≤ ±15 mg/dL difference from reference for values < 100 mg/dL	(Performance data not provided)
≤ ±15% difference from reference for values ≥ 100 mg/dL	(Performance data not provided)
At least 95% of results within these limits	(Performance data not provided)
Precision (Repeatability and Intermediate Precision):
Typically CV% or SD at various glucose concentrations	(Performance data not provided)

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

The provided document does not contain any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). This information would typically be detailed in the study report itself.

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

The provided document does not contain any information regarding the number or qualifications of experts used to establish the ground truth. For blood glucose monitors, the "ground truth" (reference method) is typically established using a high-precision laboratory analyzer, not usually by human experts in the same way as, for example, diagnostic imaging.

4. Adjudication Method for the Test Set

As the "ground truth" for blood glucose monitors is typically an objective measurement from a laboratory reference method, an adjudication method (like 2+1, 3+1 consensus) for the test set is generally not applicable or mentioned in the context of device accuracy for this type of product.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

MRMC comparative effectiveness studies are typically performed for diagnostic imaging devices where human interpretation is a key component and the AI's role is to assist human readers. For a blood glucose monitoring system like the ReliOn™ Premier Classic, which is a standalone measurement device, an MRMC study is not relevant or applicable, and therefore, no information is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The ReliOn™ Premier Classic Blood Glucose Monitoring System is a standalone device. Its performance, as designed and intended, is the "algorithm only" or system-only performance without a human-in-the-loop directly interpreting the result for diagnostic purposes (the human reads the result and takes action, but doesn't "interpret" it in the way a radiologist interprets an image). Therefore, the accuracy and precision studies performed for such a device would inherently be standalone performance studies.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by measurements from a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is considered highly accurate and precise. The provided document does not explicitly state the type of ground truth used, but this is the standard practice for such devices.

8. The Sample Size for the Training Set

The provided document does not contain any information regarding the sample size for a training set. Blood glucose meters do not typically involve "training" a machine learning algorithm in the same way modern AI algorithms do. Their calibration and algorithms are developed based on extensive characterization using chemical and electrical engineering principles, and clinical/analytical validation. If there were "training data" for a calibration curve, it would be part of the device's inherent design and manufacturing process, rather than a separate "training set" in the AI sense.

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

As noted above, the concept of a "training set" and establishing ground truth for it, in the context of machine learning, is not explicitly applicable to a traditional blood glucose monitoring system. The device's calibration and measurement principles are based on established electrochemical reactions and sensor design, validated against laboratory reference methods.

Summary

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December 13, 2019

i-SENS, Inc. Joon Ho Jung Regulatory Affairs Senior Manager 43, Banpo-daero 28-gil, Seocho-gu Seoul, 06646 Korea

Re: K192220

Trade/Device Name: ReliOn™ Premier Classic Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: November 15, 2019 Received: November 15, 2019

Dear Joon Ho Jung:

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.

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

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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,

Marianela Perez-Torres. Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192220

Device Name

ReliOn™ Premier Classic Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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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.