NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System

K171480 · I-Sens, Inc. · NBW · Dec 13, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171480
• Device Name: NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Blood glucose monitoring system; measures glucose levels from capillary whole blood samples; utilizes electrochemical biosensor technology; modified to include Bluetooth module for wireless data transmission to mobile devices; intended for home use by patients; firmware updated to support Bluetooth pairing and automatic data transfer; healthcare providers access data via mobile device integration; facilitates patient self-management of glucose levels.

Clinical Evidence

No clinical data provided. Bench testing included disinfection efficacy studies using Clorox Germicidal Wipes (EPA Reg. No: 67619-12) demonstrating complete inactivation of HBV, and robustness studies confirming no performance degradation after 260 cleaning/disinfection cycles (simulating 5 years of use).

Technological Characteristics

Electrochemical glucose biosensor; includes Bluetooth module for wireless connectivity; firmware-based data management; compatible with mobile devices; validated for 260 cleaning/disinfection cycles using Clorox Germicidal Wipes.

Indications for Use

Indicated for single-patient home use for the monitoring of blood glucose levels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NoCoding1 Plus Blood Glucose Monitoring System (K160742)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------|-------------|
| <div></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| <div></div> Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> |

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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 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input checked="" type="checkbox"/> |

### 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 [e-mail]

"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: [phone] Fax: [phone]

k171480

### 510(k) Summary

(As required by 21 CFR 807.92)

| Introduction: | This summary of 510(k) information is being submitted in accordance<br>with requirements of 21 CFR Part 807.92. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k): | Special 510(k) |
| Submitter Information: | i-SENS, Inc.<br>43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea<br>Tel.) [phone]<br>Fax) [phone]<br>e-mail: [e-mail]<br>Contact Person: Joon Ho Jung |
| Prepared Date: | December 13, 2017 |
| Device Name | NoCoding1 Plus Blood Glucose Monitoring System<br>VeraSens 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: [phone] Fax: [phone]

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. The following items are included in the NoCoding1 Plus and VeraSens Blood Glucose Monitoring system:

- -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:

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.

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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: [phone] Fax: [phone]

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 Device<br>NoCoding1 Plus Blood Glucose Monitoring System, K160742 | Candidate Device<br>NoCoding1 Plus Blood Glucose Monitoring System<br>VeraSens Blood Glucose Monitoring System | |
| Intended Use | The NoCoding1 Plus Blood Glucose Monitoring System is<br>intended for the quantitative measurement of glucose in fresh<br>capillary whole blood samples drawn from the fingertip. The<br>NoCoding1 Plus Blood Glucose Monitoring System is<br>intended for self-testing outside the body (for in vitro<br>diagnostic use) by people with diabetes at home as an aid to<br>monitor the effectiveness of diabetes control. The system is<br>intended to be used by a single person and should not be<br>shared. It is not intended for use on neonates and is not for the<br>diagnosis or screening of diabetes.<br>The NoCoding1 Blood Glucose Test Strips are for use with the<br>NoCoding1 Plus Blood Glucose Meters to quantitatively<br>measure glucose in fresh capillary whole blood samples drawn<br>from the fingertip.<br>The NoCoding1 Glucose Control Solutions are for use with<br>the NoCoding1 Plus Blood Glucose Meters and NoCoding1<br>Blood Glucose Test Strips to check that the meter and the test<br>strips are working together properly and that the test is<br>performing correctly. | Same | |
| Common name | System, test, blood glucose, over the counter | Same | |
| Test Principle | Electro-chemical reaction. The glucose meter measures<br>electrical current generated by enzyme using the glucose as<br>substrate in sample. | Same | |
| Enzyme | Glucose Oxidase<br>- Glucose Oxidase (Aspergillus sp.): 2.7 units | Same | |
| | - Hexaamineruthenium(III) chloride: 45.7 µg<br>- 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<br>(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: [phone] Fax: [phone]

#### 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

| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Pos<br>t) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
|-------------------------------------------------|----------------------------------------------------------------------------------|----------------------------|---------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| H2<br>User errors<br>and/or<br>unawareness | The user may<br>experience<br>inconvenience<br>from the newly<br>designed meter. | Minor/<br>Minor | Probable/<br>Remote | AFAP/A<br>CC | Human Factor<br>Study | When user fails to recognize the<br>modified housing features, there is a<br>risk of user inconvenience.<br>Therefore, human factor study was<br>done to verify the user convenience<br>of using the meter. Although the<br>residual risk still exists, it is not in<br>the non-acceptable region. The<br>benefit of the meter is to enable the<br>user to manage their glucose level. It<br>ultimately contributes to the user's<br>health.<br>Therefore the benefits<br>outweigh this risk. | * BGM-027B-<br>R009_Human<br>Factor Study<br>Report_(Section<br>012) | Completed |
| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Pos<br>t) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
| H25<br>Cybersecurity<br>problem | Bluetooth<br>connection<br>between<br>meter<br>and<br>unintended<br>device | Minor/<br>Minor | Occasional/<br>Remote | AFAP<br>/ACC | Restriction<br>on<br>display time of<br>showing<br>Passkey | When<br>Bluetooth<br>connection<br>between the meter and unintended<br>device is complete, there is a risk<br>that user can be damaged by<br>cybersecurity problem. Therefore,<br>Passkey entry and short display time<br>of showing Passkey was adopted to<br>prevent that situation and software<br>function test was done to verify this.<br>Also counter measure to lower<br>probability of the risk has been done<br>by adding explanation in user<br>manual. The meter was designed<br>meeting Bluetooth SIG standard and<br>it was described in Bluetooth<br>communication protocol. Therefore<br>the residual risk falls from AFAP to<br>ACC region. Although the residual<br>risk still exists, it is not in the non-<br>acceptable region. The benefit of the<br>meter is to enable the user to manage<br>their glucose level. It ultimately<br>contributes to the user's health.<br>Therefore the benefits outweigh this<br>risk. | BGM-018B-<br>R021_Software<br>Function Test<br>(Section 016) | Completed |
| H25<br>Cybersecurity<br>problem | Data<br>transmission<br>without data<br>encryption | Minor<br>/Minor | Remote<br>/Improbable | ACC<br>/ACC | Product<br>design<br>which<br>meets<br>Bluetooth<br>SIG<br>standard | When data is exposed while meter<br>transmits the data, there is a risk that<br>damaged<br>user<br>can<br>be<br>by<br>cybersecurity problem. Therefore<br>the meter was designed meeting<br>Bluetooth SIG standard and it was<br>described<br>in<br>Bluetooth<br>communication<br>protocol.<br>Also,<br>Bluetooth SIG certification was<br>received.<br>This<br>verifies<br>that | Bluetooth<br>SIG<br>certification | Completed |
| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Pos<br>t) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
| | | | | | | | | |
| H25<br>Cybersecurity<br>problem | Outside<br>intrusion<br>during UART<br>communicati<br>on | Minor<br>/Minor | Occasional<br>/Remote | AFAP<br>/ACC | Connect with a<br>device using the<br>protocol<br>designed by i-<br>SENS, Inc.<br>(BGM-TCF-14-<br>025_Communic<br>ation<br>Protocol<br>for UART) | Outside intrusion during UART<br>communication, there is a risk that<br>user can be damaged. To reduce the<br>risk, the meter connects with other<br>device one-to-one and only use the<br>communication protocol designed<br>by i-SENS, Inc.<br>Therefore the residual risk falls from<br>AFAP to ACC region. Although the<br>residual risk still exists, it is not in<br>the non-acceptable region. The<br>benefit of the meter is to enable the<br>user to manage their glucose level. It<br>ultimately contributes to the user's<br>health.<br>Therefore<br>the benefits<br>outweigh this risk. | User Manual<br>pg. 10, 41 | Completed |
| H16<br>Software<br>problem | Error<br>of<br>download<br>function using<br>UART<br>communicati<br>on | Minor | Occasional/<br>Remote | AFAP/<br>ACC | Memory Test | When software fails to download the<br>data properly, there is a risk of user<br>inconvenience. Therefore, memory<br>test was done to verify the memory<br>function of the meter and lower the<br>probability of the risk. Therefore the<br>residual risk falls from AFAP to<br>ACC region Although the residual<br>risk still exists, it is not in the non-<br>acceptable region. The benefit of the | BGM-027B-<br>R023_3_Memory<br>Test | Complete |
| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Pos<br>t) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
| | | | | | | meter is to enable the user to manage<br>their glucose level. It ultimately<br>contributes to the user's health.<br>Therefore the benefits outweigh this<br>risk. | | |
| H4<br>Electromagnetic<br>field<br>compatibility | Electromagne<br>tic field effect<br>during<br>Bluetooth<br>communicati<br>on | Minor<br>/Minor | Occasional<br>/Remote | AFAP<br>/ACC | EMC test report<br>Caution<br>indication<br>(Manual) | When meter is exposed to<br>electromagnetic field, there is a risk<br>of meter's damaging and<br>malfunction. Therefore, counter<br>measure to lower the probability of<br>the risk has been done by adding<br>related caution indication phrase in<br>the user manual. Therefore the<br>residual risk falls from AFAP to<br>ACC region. Although the residual<br>risk still exists, it is not in the non-<br>acceptable region. The benefit of the<br>meter is to enable the user to manage<br>their glucose level. It ultimately<br>contributes to the user's health.<br>Therefore the benefits outweigh this<br>risk. | EMC Test report<br>(NK-15-E-0779)<br>Caution indication<br>(Manual) | Complete |
| H4<br>Electromagnetic<br>field<br>compatibility | Electromagne<br>tic field effect<br>during<br>Bluetooth<br>communicati<br>on | Minor | Occasional/<br>Remote (2) | AFAP/<br>ACC | SIG Certificate<br>FCC Part 15<br>Subpart B &<br>Part 2<br>EMC Safety<br>Test<br>IEC 60601-1-2:<br>2007,<br>EN 60601-1-<br>2:2007/AC:201<br>0<br>IEC 61010- | When meter is exposed to<br>electromagnetic field, there is a risk<br>of meter's damaging and<br>malfunction. Therefore, R&TTE<br>and FCC test was done to verify that<br>there is no problem of meter's<br>electromagnetic field effect and<br>lowers the probability of the risk.<br>Also, counter measure to lower the<br>probability of the risk has been done<br>by adding related caution indication<br>phrase in the user manual. Therefore<br>the residual risk falls from AFAP to<br>ACC region. Although the residual | Qualified SIG<br>Design ID: 78922<br>FCC<br>(NK-15-E-0781(i-<br>Sens_GM01BAB)<br>_FCC)<br>EMC<br>(NK-15-E-0779)<br>Safety<br>(KR-KETI2885) | Complete |
| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Pos<br>t) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
| | | | | | 1:2010, IEC<br>61010-2-<br>101:2015 | risk still exists, it is not in the non-<br>acceptable region. The benefit of the<br>meter is to enable the user to manage<br>their glucose level. It ultimately<br>contributes to the user's health.<br>Therefore the benefits outweigh this<br>risk. | | |
| H2<br>User errors<br>and/or<br>unawareness | Difficulties of<br>performing<br>Bluetooth<br>pairing<br>process | Minor | Probable<br>Remote | AFAP<br>ACC | Use instruction | When user fails to transfer meter<br>data to his/her device via Bluetooth<br>connection, there is a risk of user<br>inconvenience. Therefore, counter<br>measure to lower the probability of<br>the risk has been done by adding use<br>instruction in the user manual.<br>Therefore the residual risk falls from<br>AFAP to ACC region. Although the<br>residual risk still exists, it is not in<br>the non-acceptable region. The<br>benefit of the meter is to enable the<br>user to manage their glucose level. It<br>ultimately contributes to the user's<br>Therefore<br>health.<br>the benefits<br>outweigh this risk. | User manual, pg. 37<br>Additional<br>Bluetooth pairing<br>quick guide<br>Proposed labeling) | Complete |
| HI Q<br>Software<br>problem | of<br>Error<br>download<br>function using<br>Bluetooth<br>communicati<br>on | Minor | Occasional<br>Remote | AFAP<br>ACC | Memory test | When software fails to download the<br>data properly, there is a risk of user<br>inconvenience. Therefore, memory<br>test was done to verify the memory<br>function of the meter and lower the<br>probability of the risk. Therefore the<br>residual risk falls from AFAP to<br>ACC region Although the residual<br>risk still exists, it is not in the non-<br>acceptable region. The benefit of the<br>meter is to enable the user to manage<br>their glucose level. It ultimately | BGM-027B-<br>R023_3_Memory<br>l'est | Complete |
| Potential<br>Hazard | Potential<br>cause(s) | Severity<br>(Pre/<br>Post) | Likelihood<br>(Pre/Post) | Risk<br>(Pre/Post) | Controls<br>(Counter<br>measure) | Risk/Benefit Analysis | Test ID | Completeness<br>of risk control |
| | | | | | | contributes to the user's health.<br>Therefore the benefits outweigh this<br>risk. | | |

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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: [phone] Fax: [phone]

#### Conclusion

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