The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The NoCoding1 Plus 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 NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The VeraSens Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The VeraSens 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 VeraSens Blood Glucose Test Strips are for use with the VeraSens Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Description

The NoCoding1 Plus BGMS and VeraSens BGMS is a derivation from the same design file as its predicate device, NoCoding1 Plus Blood Glucose Monitoring System with the addition of a Bluetooth module. 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.

The NoCoding1 Plus BGMS and VeraSens BGMS 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 NoCoding1 Plus BGMS and VeraSens BGMS 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 text describes the i-SENS NoCoding1 Plus Blood Glucose Monitoring System and VeraSens Blood Glucose Monitoring System. The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full study with acceptance criteria and detailed performance data.

However, I can extract information related to acceptance criteria and device performance based on the type of device and the context provided. The non-clinical section states that "Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This indicates that acceptance criteria were defined, and the device met them.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data for glucose measurement accuracy. However, it implicitly refers to established "pre-determined Pass/Fail criteria" for verification, validation, and testing activities. Given the device type (blood glucose monitoring system), these criteria would typically refer to accuracy standards like those set by ISO 15197 (e.g., specific percentages of results within +/- certain mg/dL or %). The document does not provide the specific numerical acceptance criteria or the reported device performance in terms of accuracy metrics (e.g., mean absolute relative difference, percentage within limits).

The provided non-clinical summary focuses more on functional aspects related to the addition of a Bluetooth module, cleaning/disinfection, and cybersecurity.

Acceptance Criteria Category (Implied)	Reported Device Performance (as described)
Glucose Measurement Accuracy	"Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." (Specific numerical accuracy metrics (e.g., % within +/- 15 mg/dL) are not detailed in this summary.)
Cleaning and Disinfection Effectiveness	"Results demonstrated complete inactivation of live virus inoculated on the materials of the meter and lancing device."
Durability after Cleaning/Disinfection	"260 each of pre-cleaning and disinfection cycles for meter... has no effect on the performance or the external materials of the meter and lancing device."
Cybersecurity (Bluetooth connection to unintended device)	"Passkey entry and short display time of showing Passkey was adopted to prevent that situation and software function test was done to verify this." "Residual risk falls from AFAP to ACC region."
Cybersecurity (Data transmission without encryption)	"Product design which meets Bluetooth SIG standard." "Bluetooth SIG certification was received."
Cybersecurity (Outside intrusion during UART communication)	"Connect with a device using the protocol designed by i-SENS, Inc." "User Manual pg. 10, 41." "Residual risk falls from AFAP to ACC region."
Software Function (Error of download function using UART/Bluetooth)	"Memory Test was done to verify the memory function of the meter and lower the probability of the risk." "Residual risk falls from AFAP to ACC region."
Electromagnetic Field Compatibility	"EMC test report, Caution indication (Manual)." "R&TTE and FCC test was done to verify that there is no problem of meter's electromagnetic field effect." "Residual risk falls from AFAP to ACC region."
User Errors/Unawareness (Human Factor Study)	"Human Factor Study was done to verify the user convenience of using the meter." "Residual risk still exists, it is not in the non-acceptable region."
User Errors/Unawareness (Bluetooth pairing difficulties)	"Use instruction in the user manual." "Residual risk falls from AFAP to ACC region."

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 for Test Set: This information is not explicitly provided in the summary for the core glucose measurement accuracy testing. For cleaning and disinfection, it states "260 each of pre-cleaning and disinfection cycles."
Data Provenance: Not specified. The document is from i-SENS, Inc. in Seoul, Korea, which is the manufacturer's location, but this does not confirm the origin of patient data (if any was used for core performance studies).
Retrospective or Prospective: Not specified.

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 laboratory-reference methods (e.g., YSI analyzer) rather than expert consensus on images.

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

This information is not provided and is generally not applicable for direct blood glucose measurement devices; it's more relevant to image-based diagnostic systems.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI-assisted interpretation of medical images, which is not the function of a blood glucose monitoring system.

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

The device is a standalone blood glucose meter. Its performance is evaluated by comparing its readings to a reference method, not by an algorithm's performance in abstract. The "standalone" performance is the device's performance in generating a glucose reading. The document confirms "Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices," indicating standalone performance evaluation.

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

The document does not explicitly state the ground truth method. For blood glucose monitoring systems, the ground truth for glucose measurements is almost universally established by a traceable laboratory reference method (e.g., using a YSI glucose analyzer), not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. As this device is based on electrochemical biosensor technology and likely uses fixed algorithms, the concept of a "training set" in the context of machine learning (as often seen with AI devices) may not directly apply or is not detailed in this type of 510(k) summary for a blood glucose meter.

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

This information is not provided, and as noted above, the concept of a "training set" with ground truth in the AI sense might not be applicable here. If internal calibration/development involved a "training set" of samples, the ground truth would typically be established by a laboratory reference method.

Summary

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December 13, 2017

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

Re: K171480

Trade/Device Name: NoCoding1 Plus Blood Glucose Monitoring System VeraSens Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 10, 2017 Received: November 13, 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -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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Indications for Use

510(k) Number (if known) K171480

Device Name

NoCoding1 Plus Blood Glucose Monitoring System

Indications for Use (Describe)

The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

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) K171480

Device Name

VeraSens Blood Glucose Monitoring System

Indications for Use (Describe)

The VeraSens Blood Glucose Test Strips are for use with the VeraSens Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

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.

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

K171480

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)
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:	December 13, 2017
Device Name	NoCoding1 Plus Blood Glucose Monitoring SystemVeraSens Blood Glucose Monitoring System

Blood Glucose Test System Classification Name

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

NoCoding1 Plus Blood Glucose Monitoring System, K160742. Predicate Device

Device Description The NoCoding1 Plus BGMS and VeraSens BGMS is a derivation from the same design file as its predicate device, NoCoding1 Plus Blood Glucose Monitoring System with the addition of a Bluetooth module. 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.

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Image /page/5/Picture/0 description: The image shows the logo for i-sens. The logo consists of the letter "i" in lowercase, followed by the word "sens" in lowercase. The "i" has a green dot above it, and the rest of the logo 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

-1 NoCoding1 Plus (VeraSens) Blood Glucose Meter
10 NoCoding1 (VeraSens) 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 NoCoding1 Plus BGMS and VeraSens BGMS and are available separately.

NoCoding1 brand

-NoCoding1 Blood Glucose Test Strips
-NoCoding1 Glucose Control Solution

VeraSens brand

VeraSens Blood Glucose Test Strips -
-VeraSens Glucose Control Solution

Intended Use NoCoding1 Plus BGMS:

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Image /page/6/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for a green dot above the "i" and a green dot before the word "sens". The word "sens" is in lowercase letters.

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

The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Intended Use The VeraSens Blood Glucose Monitoring System is intended for the VeraSens BGMS: quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The VeraSens 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 VeraSens Blood Glucose Test Strips are for use with the VeraSens Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Comparison to the Cleared Device

The modifications are as below:

1. Addition of Bluetooth module to the meter for wireless data transfer to mobile devices. The NoCoding1 Plus (VeraSens) meter can communicate with smart devices such as a smart phone or a tablet by SmartLog App. The unmodified device K160742 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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Comparison to the Predicate Device
Characteristic	Predicate DeviceNoCoding1 Plus Blood Glucose Monitoring System, K160742	Candidate DeviceNoCoding1 Plus Blood Glucose Monitoring SystemVeraSens 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.The NoCoding1 Glucose Control Solutions are for use withthe NoCoding1 Plus Blood Glucose Meters and NoCoding1Blood Glucose Test Strips to check that the meter and the teststrips are working together properly and that the test isperforming correctly.	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	Same
	- Hexaamineruthenium(III) chloride: 45.7 µg- Other ingredients: 1.6 µg
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 (µl)	0.5	Same
Measurement unit	mg/dL	Same
Test range (mg/dL)	20-600	Same
Operating Humidity	10~90%	Same
Control Levels	Two Levels (A and B)	Same
Power Source	Two 3.0V lithium batteries (CR2032)	Same
Memory capacity	Up to 1,000 test results	Same
Test result average range	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
Data communication	USB cable	USB cable, Bluetooth

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i·sens

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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 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, usins (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.

Cybersecurity Risk Analysis Summary

PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control
H2User errorsand/orunawareness	The user mayexperienceinconveniencefrom the newlydesigned meter.	Minor/Minor	Probable/Remote	AFAP/ACC	Human FactorStudy	When user fails to recognize themodified housing features, there is arisk of user inconvenience.Therefore, human factor study wasdone to verify the user convenienceof using the meter. Although theresidual risk still exists, it is not inthe non-acceptable region. Thebenefit of the meter is to enable theuser to manage their glucose level. Itultimately contributes to the user'shealth.Therefore the benefitsoutweigh this risk.	* BGM-027B-R009_HumanFactor StudyReport_(Section012)	Completed
PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control
H25Cybersecurityproblem	Bluetoothconnectionbetweenmeterandunintendeddevice	Minor/Minor	Occasional/Remote	AFAP/ACC	Restrictionondisplay time ofshowingPasskey	WhenBluetoothconnectionbetween the meter and unintendeddevice is complete, there is a riskthat user can be damaged bycybersecurity problem. Therefore,Passkey entry and short display timeof showing Passkey was adopted toprevent that situation and softwarefunction test was done to verify this.Also counter measure to lowerprobability of the risk has been doneby adding explanation in usermanual. The meter was designedmeeting Bluetooth SIG standard andit was described in Bluetoothcommunication protocol. Thereforethe residual risk falls from AFAP toACC region. Although the residualrisk still exists, it is not in the non-acceptable region. The benefit of themeter is to enable the user to managetheir glucose level. It ultimatelycontributes to the user's health.Therefore the benefits outweigh thisrisk.	BGM-018B-R021_SoftwareFunction Test(Section 016)	Completed
H25Cybersecurityproblem	Datatransmissionwithout dataencryption	Minor/Minor	Remote/Improbable	ACC/ACC	ProductdesignwhichmeetsBluetoothSIGstandard	When data is exposed while metertransmits the data, there is a risk thatdamagedusercanbebycybersecurity problem. Thereforethe meter was designed meetingBluetooth SIG standard and it wasdescribedinBluetoothcommunicationprotocol.Also,Bluetooth SIG certification wasreceived.Thisverifiesthat	BluetoothSIGcertification	Completed
PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control

H25Cybersecurityproblem	Outsideintrusionduring UARTcommunication	Minor/Minor	Occasional/Remote	AFAP/ACC	Connect with adevice using theprotocoldesigned by i-SENS, Inc.(BGM-TCF-14-025_CommunicationProtocolfor UART)	Outside intrusion during UARTcommunication, there is a risk thatuser can be damaged. To reduce therisk, the meter connects with otherdevice one-to-one and only use thecommunication protocol designedby i-SENS, Inc.Therefore the residual risk falls fromAFAP to ACC region. Although theresidual risk still exists, it is not inthe non-acceptable region. Thebenefit of the meter is to enable theuser to manage their glucose level. Itultimately contributes to the user'shealth.Thereforethe benefitsoutweigh this risk.	User Manualpg. 10, 41	Completed
H16Softwareproblem	Errorofdownloadfunction usingUARTcommunication	Minor	Occasional/Remote	AFAP/ACC	Memory Test	When software fails to download thedata properly, there is a risk of userinconvenience. Therefore, memorytest was done to verify the memoryfunction of the meter and lower theprobability of the risk. Therefore theresidual risk falls from AFAP toACC region Although the residualrisk still exists, it is not in the non-acceptable region. The benefit of the	BGM-027B-R023_3_MemoryTest	Complete
PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control
						meter is to enable the user to managetheir glucose level. It ultimatelycontributes to the user's health.Therefore the benefits outweigh thisrisk.
H4Electromagneticfieldcompatibility	Electromagnetic field effectduringBluetoothcommunication	Minor/Minor	Occasional/Remote	AFAP/ACC	EMC test reportCautionindication(Manual)	When meter is exposed toelectromagnetic field, there is a riskof meter's damaging andmalfunction. Therefore, countermeasure to lower the probability ofthe risk has been done by addingrelated caution indication phrase inthe user manual. Therefore theresidual risk falls from AFAP toACC region. Although the residualrisk still exists, it is not in the non-acceptable region. The benefit of themeter is to enable the user to managetheir glucose level. It ultimatelycontributes to the user's health.Therefore the benefits outweigh thisrisk.	EMC Test report(NK-15-E-0779)Caution indication(Manual)	Complete
H4Electromagneticfieldcompatibility	Electromagnetic field effectduringBluetoothcommunication	Minor	Occasional/Remote (2)	AFAP/ACC	SIG CertificateFCC Part 15Subpart B &Part 2EMC SafetyTestIEC 60601-1-2:2007,EN 60601-1-2:2007/AC:2010IEC 61010-	When meter is exposed toelectromagnetic field, there is a riskof meter's damaging andmalfunction. Therefore, R&TTEand FCC test was done to verify thatthere is no problem of meter'selectromagnetic field effect andlowers the probability of the risk.Also, counter measure to lower theprobability of the risk has been doneby adding related caution indicationphrase in the user manual. Thereforethe residual risk falls from AFAP toACC region. Although the residual	Qualified SIGDesign ID: 78922FCC(NK-15-E-0781(i-Sens_GM01BAB)_FCC)EMC(NK-15-E-0779)Safety(KR-KETI2885)	Complete
PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control
					1:2010, IEC61010-2-101:2015	risk still exists, it is not in the non-acceptable region. The benefit of themeter is to enable the user to managetheir glucose level. It ultimatelycontributes to the user's health.Therefore the benefits outweigh thisrisk.
H2User errorsand/orunawareness	Difficulties ofperformingBluetoothpairingprocess	Minor	ProbableRemote	AFAPACC	Use instruction	When user fails to transfer meterdata to his/her device via Bluetoothconnection, there is a risk of userinconvenience. Therefore, countermeasure to lower the probability ofthe risk has been done by adding useinstruction in the user manual.Therefore the residual risk falls fromAFAP to ACC region. Although theresidual risk still exists, it is not inthe non-acceptable region. Thebenefit of the meter is to enable theuser to manage their glucose level. Itultimately contributes to the user'sThereforehealth.the benefitsoutweigh this risk.	User manual, pg. 37AdditionalBluetooth pairingquick guideProposed labeling)	Complete
HI QSoftwareproblem	ofErrordownloadfunction usingBluetoothcommunication	Minor	OccasionalRemote	AFAPACC	Memory test	When software fails to download thedata properly, there is a risk of userinconvenience. Therefore, memorytest was done to verify the memoryfunction of the meter and lower theprobability of the risk. Therefore theresidual risk falls from AFAP toACC region Although the residualrisk still exists, it is not in the non-acceptable region. The benefit of themeter is to enable the user to managetheir glucose level. It ultimately	BGM-027B-R023_3_Memoryl'est	Complete
PotentialHazard	Potentialcause(s)	Severity(Pre/Post)	Likelihood(Pre/Post)	Risk(Pre/Post)	Controls(Countermeasure)	Risk/Benefit Analysis	Test ID	Completenessof risk control
						contributes to the user's health.Therefore the benefits outweigh thisrisk.

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Image /page/11/Picture/0 description: The image shows the logo for i-sens. The logo is written in a sans-serif font, with the "i" in lowercase and the rest of the word in lowercase. There is a green dot above the "i" and a smaller green dot to the left of the "s".

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Image /page/13/Picture/3 description: The image shows the logo for i-sens. The logo is written in a sans-serif font, with the "i" in lowercase and the rest of the word in lowercase. There is a green dot above the "i" and a smaller green dot to the left of the "s".

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Image /page/14/Picture/0 description: The image shows the logo for i-sens. The "i" is green, and the rest of the logo is 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

Conclusion

Based on the submitted information in this premarket notification, the candidate devices are substantially equivale 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.