The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) 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.

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.

Device Description

The CareSens N Mini Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Mini Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately}, Lancing Device, Lancets, User's Manual, Quick Reference Guide and Logbook.

AI/ML Overview

The provided document describes the "CareSens N Mini Blood Glucose Monitoring System" and details its performance assessment. However, it does not provide a table of acceptance criteria and reported device performance. It only states that validation testing, including a meter function test and system accuracy test, was conducted to confirm that modifications did not introduce any adverse effects, and that the device met performance, safety, and effectiveness for its intended use.

Therefore, many of the requested details cannot be extracted from this document based on the provided input.

Here's a breakdown of what can be extracted and what cannot:

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

Cannot be provided based on the input. The document states that validation testing was conducted and the device "met the performance, safety, and effectiveness," but it does not specify the acceptance criteria (e.g., accuracy % within certain ranges, precision limits) nor does it provide detailed reported performance values.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided based on the input for system accuracy testing. The document mentions a "human factor study" was conducted to evaluate usability, and "260 each of pre-cleaning and disinfection cycles" were performed for disinfection studies. However, for the core "system accuracy test" that would assess glucose measurement performance, the sample size, data provenance, or study design (retrospective/prospective) are not detailed.

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)

Not applicable/Cannot be provided based on the input. For a blood glucose monitoring system, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer), not by human experts interpreting results. The document does not mention the method used to establish reference glucose values.

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

Not applicable/Cannot be provided based on the input. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology AI studies) where multiple experts review cases and resolve discrepancies. This is not relevant for a blood glucose meter's accuracy testing.

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

Not applicable. MRMC studies are used for evaluating AI systems that assist human readers in tasks like image interpretation. This device is a standalone blood glucose meter, not an AI assistance system for human readers.

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

Yes, implicitly. The device itself is a standalone algorithm/system. Its performance is measured directly without a human-in-the-loop interaction in the sense of an AI assisting a human clinician's judgment. The "system accuracy test" described would be a standalone evaluation of the device's measurement capability.

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

Not explicitly stated, but implicitly a laboratory reference method. For blood glucose meters, the ground truth is established by measuring the same blood samples with a highly accurate laboratory reference instrument (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the reference method used.

8. The sample size for the training set

Not applicable/Cannot be provided based on the input. This device is a blood glucose meter using an amperometric method with glucose oxidase; it is not described as an AI/machine learning device that would typically have a "training set" in the contemporary sense. Its "algorithm" is based on established electrochemical principles.

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

Not applicable. As above, the concept of a "training set" with ground truth in this context is not applicable.

Summary

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1.20759

Image /page/0/Picture/1 description: The image shows the logo for i-sens. The logo consists of the letter 'i' in lowercase, followed by the word 'sens'. The 'i' has a dot above it, and the entire logo is encircled by a series of concentric arcs, giving the impression of a target or a signal being emitted.

ﺴﻤ

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea

Tel. 82-2-916-6191

JUN - 5 2012

510(k) Summary

(As required by 21 CFR 807.92)

Type of 510(k):	Special 510(k)
Submitted By:	i-SENS, Inc.
	465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
	Tel.) +82-2-916-6191
	Fax) +82-2-942-2514
	www.i-sens.com
Contact Person:	Dr. Hyun Joon Oh
	Tel.) +82-33-903-0760
	Fax) +82-33-748-6191
	e-mail: hjoh@i-sens.com
Prepared Date:	March 9, 2012
Device Name:	Trade name: CareSens N Mini Blood Glucose Monitoring System
	Common Name: Glucose Test System
Regulatory Information:	1) Regulation section: 21 CFR 862.1345 Glucose Test System,
	21 CFR 862.1660, Quality control material
	2) Classification: Class II, Class I, reserved
	3) Product Code: CGA - glucose oxidase, glucose
	NBW - system, test, blood glucose, over the counter
	JJX - Quality control material
	4) Panel: Clinical Chemistry (75)

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Intended Use: The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steadystate blood glucose conditions. The CareSens N Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) 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.

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.

The CareSens N Mini Blood Glucose Monitoring System (BGMS) measures Device Description: the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Mini Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately}, Lancing Device, Lancets, User's Manual, Quick Reference Guide and Logbook.
Substantial 1) Predicate Device Name: CareSens N Blood Glucose Monitoring System Equivalence Information: 2) Predicate 510(k) Number: K083468

Comparison with Predicate Device: The modified CareSens N Mini BGMS has the following features that are

ર - 2

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i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191

same to the predicate device:

intended use
. measurement principle
1 fundamental scientific technology
operating ranges

The modifications on the CareSens N BGMS to make a CareSens N Mini BGMS are:

The meter appearance, the number of required batteries and memory capacity of the Meter
트 Removal of the data transmission, data averaging and meter setting functions

The test strip is the same as that of the predicate system - the only difference is in the name (CareSens N Test Strip vs. CareSens N Single Test Strip).

Type of Test: Quantitative, Amperometric method, Glucose oxidase (Aspergillus sp.)

Test Principle: The reagent on the test strip produces a small electrical current using glucose as a substrate in the blood sample. The Meter converts the electrical current to a concentration of glucose.

Technological The CareSens N Mini BGMS has the same fundamental scientific technology Characteristics: as the predicate device.

The basic features of the CareSens N Mini BGMS are all the same with the Assessment of Performance predicate device except for the meter's appearance and output value (including the memory capacity). The CareSens N Mini BGMS uses the same Characteristics: test strips (just a different name) and control solutions being used in the CareSens N BGMS. So, its performance, safety and effectiveness have not changed from the predicate device. However, in order to confirm the modifications have not introduced any adverse effect validation testing including the meter function test and system accuracy test were conducted.

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And to evaluate the usability the newly designed CareSens N Mini meter, the human factor study were conducted. The result indicates that the modified. meter is as ease to use as the predicate device.

Summary of Disinfection studies were performed on the CareSens N Mini meter and Pre-cleaning and lancing device by an outside commercial testing service to determine the Disinfection: robustness of the meter and lancing device to the recommended pre-cleaning and disinfection protocol, and its effectiveness in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12) was validated for complete inactivation of live virus inoculated on the materials of the meter and lancing device. We have also demonstrated that 260 each of pre-cleaning and disinfection cycles designed to simulate 5 years of use has affected neither the performance nor on the external materials for the meter and lancing device.

Conclusion:

Based on the information provided in this submission, the CareSens N Mini BGMS is substantially equivalent to the predicate devices. A candidate device CareSens N Mini BGMS has met the performance, safety, and effectiveness of the device for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with three curved lines representing its body and wings. The bird is positioned in the center of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the top half of the circle.

10903 New Hampshire Avenue Silver Spring, MD 20993

JUN - 5 2012

i-SENS, Inc. c/o Hyun Joon Oh 465-6 Wolgye-dong, Nowon-gu Seoul Republic of Korea 139-845

K120759 Re:

K120759
Trade Name: CareSens N Mini Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: May 3, 2012 Received: May 8, 2012

Dear Dr. Oh:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your securer sized the device is substantially equivalent (for the It it it is a dove and have acceminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale comments, or to 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 the Federal Pood, Drug, and Cosment . For (+10) ... market the devices subject to the general approval appreation (1 MIT). 1 ou . . - ), The general controls provisions of the Act include condons provisions of the fiction, 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 If your device is classified ($60 additional controls. Existing major regulations affecting (PMA), it may be subject to such acantoner over.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partin the Fodors your device can oc found in This 22, Coursements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements meall that IDA has made a determination administered by other Federal agencies. of the Act of ally rederal statutes and regulations. but not limited to: registration You must comply with an the Net Birdger of CFR Parts 801 and 809); medical device and fishing (21 CFR Part 607), labering (21 CFR 803); and good reporting (reporting of medical device relation 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/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 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/Resourcesfor You/Industry/default.htm

Sincerely yours,

C. Gary H. Lisc, Ph.D.

Counney 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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Indications for Use Form

510(k) Number (if known): K 120759

Device Name: CareSens N Mini Blood Glucose Monitoring System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ><

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120754

Page 1 of

4 - 1

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.