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

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

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

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Description

CareSens N Premier brand of Blood Glucose Monitoring System is designed to have two variation models, CareSens N Premier BGMS and CareSens N Premier BT BGMS. CareSens N Premier BGMS is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, CareSens N Premier BT BGMS is implemented with all of the changes stated in the submission. The two meters use the same CareSens N Single Test Strip and CareSens Control Solution.

CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System consist of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges).

The CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.

AI/ML Overview

The provided document is a 510(k) premarket notification for a blood glucose monitoring system, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device evaluation, such as expert-based ground truth, MRMC studies, and training set information, are not applicable or cannot be extracted from this document.

However, I can provide information pertaining to the device's performance given the type of medical device it is (a blood glucose monitor):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a table format for performance beyond what is listed implicitly for substantial equivalence to the predicate device. However, it mentions "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies that internal acceptance criteria were met.

The performance characteristics mentioned are primarily those of the device's technical specifications and intended use, which are deemed "Same" as the predicate device (NoCoding1 Plus Blood Glucose Monitoring System, K160742).

Characteristic	Predicate Device (NoCoding1 Plus)	Candidate Device (CareSens N Premier / BT)	Reported Performance (Implicitly "Passed" or "Same")
Intended Use	Quantitative glucose measurement in fresh capillary whole blood for self-testing at home by people with diabetes. Not for neonates or diagnosis/screening of diabetes.	Same	Met (Substantially Equivalent)
Common Name	System, test, blood glucose, OTC	Same	Met (Substantially Equivalent)
Test Principle	Electro-chemical reaction, glucose meter measures electrical current generated by enzyme (glucose oxidase)	Same	Met (Substantially Equivalent)
Enzyme	Glucose Oxidase (Aspergillus sp.): 2.7 units; Hexaamineruthenium(III) chloride: 45.7 µg; Other ingredients: 1.6 µg	Same	Met (Substantially Equivalent)
Measurement Principle	Amperometric method	Same	Met (Substantially Equivalent)
Sample Type	Fresh capillary whole blood	Same	Met (Substantially Equivalent)
Calibration	Plasma-equivalent	Same	Met (Substantially Equivalent)
Coding System	No coding required (Automatic code identification)	Same	Met (Substantially Equivalent)
Test Time (sec.)	5	Same	Met (Substantially Equivalent)
Sample Volume (ul)	0.5	Same	Met (Substantially Equivalent)
Measurement Unit	mg/dL	Same	Met (Substantially Equivalent)
Test Range (mg/dL)	20-600	Same	Met (Substantially Equivalent)
Operating Humidity	10~90%	Same	Met (Substantially Equivalent)
Power Source	Two 3.0V lithium batteries (CR2032)	Same	Met (Substantially Equivalent)
Memory Capacity	Up to 1,000 test results	Same	Met (Substantially Equivalent)
Test Result Average Range	1, 7, 14, 30 and 90 days (Pre-meal, Post-meal, Fasting and Total)	Same	Met (Substantially Equivalent)
Operating Temperature	42.8-111.2°F	Same	Met (Substantially Equivalent)
Hematocrit Range (%)	15~65	Same	Met (Substantially Equivalent)

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

The document does not specify the exact sample size for clinical test sets. For disinfection studies, it mentions "260 each of pre-cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 5 years (260 each of pre-cleaning and disinfection cycles for meter and lancing device) of single patient device use". This relates to the durability of the device after disinfection, not its accuracy in reading blood glucose. The provenance of this data is a "commercial testing service."

The document generally refers to "non-clinical verification, validation and testing activities" as having been conducted. Typically, for blood glucose meters, these would involve studies with human subjects (prospective clinical studies) to compare the device readings against a laboratory reference method. However, the details of these studies (e.g., number of subjects, whether prospective or retrospective, country of origin) are not provided in this summary.

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

This information is not applicable to a blood glucose monitoring system in the same way it would be for an AI/ML diagnostic device. The "ground truth" for a blood glucose meter is typically established by comparing its readings to a gold- standard laboratory reference method (e.g., YSI glucose analyzer), not expert consensus. The document does not specify the number or qualifications of individuals involved in generating this reference data.

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

Not applicable for this type of device. Adjudication methods like 2+1 are used in AI/ML performance studies where human interpretations are being assessed and potentially reconciled. For a blood glucose meter, the measurement is numerical and compared directly to a reference value.

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. This is a blood glucose meter, not an AI-assisted diagnostic tool that involves human "readers."

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

The device (CareSens N Premier / BT Blood Glucose Monitoring System) is a standalone system for measuring glucose. Its performance is evaluated on its own, with the user taking the measurement. There is no separate "algorithm only" performance reported in the context of an AI/ML algorithm.

7. The type of ground truth used:

For blood glucose meters, the ground truth is typically established by comparison to a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the reference method used but this is standard practice for glucose meters.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a separate "training set" in the machine learning sense. The device is based on electrochemical biosensor technology.

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

Not applicable, as it is not an AI/ML device with a training set.

Summary

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

October 19, 2017

I-SENS, INC. JOON HO JUNG RA TEAM MANAGER 43, BANPO-DAERO, 28-GIL, SEOCHO-GU 06646, SEOUL, KOREA

Re: K170614

Trade/Device Name: CareSens N Premier Monitoring System CareSens N Premier BT Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: September 18, 2017 Received: September 19, 2017

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. 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 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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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" (21 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/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 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.

Sincerely yours,

Stayce Beck -A

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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Indications for Use

510(k) Number (if known)

K170614

Device Name CareSens N Premier Monitoring System

Indications for Use (Describe)

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)	☑

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K170614

Device Name CareSens N Premier BT Monitoring System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for i-sens. The "i" is blue with a green dot above it. The rest of the word, "-sens" is in blue. The logo is simple and modern.

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

510(k) Summary

(As required by 21 CFR 807.92)

Introduction:	This summary of 510(k) information is being submitted in accordancewith requirements of 21 CFR Part 807.92.
Type of 510(k):	Special 510(k)
510k Number	K170614
Submitter Information:	i-SENS, Inc.43, Banpo-daero 28-gil, Seocho-gu, Seoul, KoreaTel.) +82-2-916-6191Fax) +82-2-942-2514e-mail: jhjung@i-sens.comContact Person: Joon Ho Jung
Prepared Date:	February, 24th, 2017
Device Name	CareSens N Premier Blood Glucose Monitoring SystemCareSens N Premier BT Blood Glucose Monitoring System
Classification Name	Blood Glucose Test System

Product Code	Classification	Regulation Section	Panel
NBW	Class II	21 CFR 862.1345Blood Glucose Test System	Clinical Chemistry 75

Predicate Device NoCoding1 Plus Blood Glucose Monitoring System, K160742.

Device Description CareSens N Premier brand of Blood Glucose Monitoring System is designed to have two variation models, CareSens N Premier BGMS and CareSens N Premier BT BGMS. CareSens N Premier BGMS is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, CareSens N Premier BT BGMS is implemented with all of the changes stated in the submission. The two meters use the same CareSens N

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

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

Single Test Strip and CareSens Control Solution. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device. NoCoding1 Plus Blood Glucose Monitoring System, K160742.

1 Blood Glucose Meter -
-10 Blood Glucose Test Strips
1 Lancing device -
-10 Lancets
1 Owner's Booklet -
-1 Quick Reference Guide
-2 Batteries (3.0V lithium batteries)

The following items are compatible with the CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System and are available separately.

-CareSens N Single Blood Glucose Test Strips
-CareSens Glucose Control Solution

Intended Use: The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier 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

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Image /page/6/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for two green dots. The first green dot is above the "i" and the second green dot is to the left of the "s".

i-SENS. Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

and is not for the diagnosis or screening of diabetes.

Comparison to the Cleared Device

The modifications are as below:

1. Change in the housing case of the meter
-Button positioning from the sides to the front of the meter (PC to Silicone Rubber).
-The material of the meter screen changed from PC to PMMA.
-Addition of ejection button (new material: POM).
-The material of the foot of the meter from TPU to TPE.
Meter shell color -
Addition of backlight to meter screen -
1. Trade name of the system changed from NoCoding1 Plus Blood Glucose Monitoring System to CareSens N Premier and CareSens N Premier BT Blood Glucose Monitoring System.
1. Addition of Bluetooth module to the meter for wireless data transfer to mobile devices (applies to GM01AAB only). The CareSens N Premier BT (GM01AAB) meter can communicate with smart devices such as a smart phone or a tablet by SmartLog App. The unmodified device K 160742

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Image /page/7/Picture/0 description: The image shows the logo for i-sens. The logo is written in a sans-serif font, with the "i" in green and the rest of the word in blue. The "i" has a green circle above it, and a green dot below it. The logo is simple and modern.

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

already had the data transfer function of transmitting the stored information to PC via a USB cable.

Other than these modifications, the following remains the same to the cleared device:

-Has the same intended use,
Uses the same operating principle, -
Utilizes the same use environment and calibration method. -

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i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

Comparison to the Predicate Device
Characteristic	Predicate DeviceNoCoding1 Plus Blood Glucose Monitoring System, K160742	Candidate DeviceCareSens N Premier Blood Glucose Monitoring SystemCareSens N Premier BT Blood Glucose Monitoring System
Intended Use	The NoCoding1 Plus Blood Glucose Monitoring System isintended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertip. TheNoCoding1 Plus Blood Glucose Monitoring System isintended for self-testing outside the body (for in vitrodiagnostic use) by people with diabetes at home as an aid tomonitor the effectiveness of diabetes control. The system isintended to be used by a single person and should not beshared. It is not intended for use on neonates and is not for thediagnosis or screening of diabetes.The NoCoding1 Blood Glucose Test Strips are for use with theNoCoding1 Plus Blood Glucose Meters to quantitativelymeasure glucose in fresh capillary whole blood samples drawnfrom the fingertip.	Same
Common name	System, test, blood glucose, over the counter	Same
Test Principle	Electro-chemical reaction. The glucose meter measureselectrical current generated by enzyme using the glucose assubstrate in sample.	Same
Enzyme	Glucose Oxidase- Glucose Oxidase (Aspergillus sp.): 2.7 units- Hexaamineruthenium(III) chloride: 45.7 µg- Other ingredients: 1.6 µg	Same
Measurement Principle	Amperometric method	Same
Sample type	Fresh capillary whole blood	Same
Calibration	Plasma-equivalent	Same
Coding system	No coding required (Automatic code identification)	Same
Test time (sec.)	5	Same
Sample volume (ul)	0.5	Same
Measurement unit	mg/dL	Same
Test range (mg/dL)	20-600	Same
Operating Humidity	10~90%	Same
Power Source	Two 3.0V lithium batteries (CR2032)	Same
Memory capacity	Up to 1,000 test results	Same
Testresultaveragerange	1, 7,14, 30 and 90 days(Pre-meal, Post-meal, Fasting and Total)	Same
Operating Temperature	42.8-111.2°F	Same
Hematocrit range (%)	15~65	Same

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i·sens

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

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Image /page/10/Picture/0 description: The image shows the logo for i-sens. The logo is in blue, except for a green dot above the 'i'. The text is in lowercase and has a modern, sans-serif font. The logo is simple and clean, and it is likely used to represent the company's brand.

i-SENS. Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

Performance Data

Non-clinical

Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Cleaning and Disinfection

The device is intended for single patient home use. Disinfection studies were performed on the meter and lancing device by an outside commercial testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12), in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). The results demonstrated 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 for meter with the same disinfectant designed to simulate 5 years (260 each of pre-cleaning and disinfection cycles for meter and lancing device) of single patient device use has no effect on the performance or the external materials of the meter and lancing device.

Conclusion

Based on the submitted information in this premarket notification, the candidate devices are substantially equivalent to the predicate device.

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.