(208 days)
Not Found
No
The document describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is intended for measurement and monitoring, not for providing therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not for the diagnosis or screening of diabetes."
No
The device description explicitly states that the system consists of a blood glucose meter, single use test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for self testing outside the body (in vitro)".
- Measurement: It measures glucose in "fresh capillary whole blood samples drawn from the fingertips". This is a biological sample tested in vitro (outside the body).
- System Components: The system includes a blood glucose meter, test strips, and control solutions, all components typical of an IVD system for measuring analytes in biological samples.
- Technology: It uses "electrochemical biosensor technology", which is a common method for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
NBW
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. 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
self testing outside the body (in vitro) by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) | |
|---|---|
| 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."
3
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) | |
|---|---|
| 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."
4
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
510(k) Summary
(As required by 21 CFR 807.92)
| Introduction: | This summary of 510(k) information is being submitted in accordance
with 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, Korea
Tel.) +82-2-916-6191
Fax) +82-2-942-2514
e-mail: jhjung@i-sens.com
Contact Person: Joon Ho Jung |
| Prepared Date: | December 13, 2017 |
| Device Name | NoCoding1 Plus Blood Glucose Monitoring System
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.
5
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
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.
6
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:
-
- 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:
- 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.
-
Has the same intended use, -
-
Uses the same operating principle, -
-
Utilizes the same use environment and calibration method. -
7
| Comparison to the Predicate Device | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| NoCoding1 Plus Blood Glucose Monitoring System, K160742 | Candidate Device | ||
| NoCoding1 Plus Blood Glucose Monitoring System | |||
| VeraSens Blood Glucose Monitoring System | |||
| 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 fingertip. The | |||
| NoCoding1 Plus Blood Glucose Monitoring System is | |||
| intended for self-testing outside the body (for 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 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 NoCoding1 Glucose Control Solutions are for use with | |||
| the NoCoding1 Plus Blood Glucose Meters and NoCoding1 | |||
| Blood Glucose Test Strips to check that the meter and the test | |||
| strips are working together properly and that the test is | |||
| performing correctly. | Same | ||
| Common name | System, test, blood glucose, over the counter | Same | |
| Test Principle | Electro-chemical reaction. The glucose meter measures | ||
| electrical current generated by enzyme using the glucose as | |||
| substrate 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 | 1090% | Same | |65 | 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
| Data communication | USB cable | USB cable, Bluetooth | |
8
i·sens
9
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
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Pos
t) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
|-------------------------------------------------|----------------------------------------------------------------------------------|----------------------------|---------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| H2
User errors
and/or
unawareness | The user may
experience
inconvenience
from the newly
designed meter. | Minor/
Minor | Probable/
Remote | AFAP/A
CC | Human Factor
Study | When user fails to recognize the
modified housing features, there is a
risk of user inconvenience.
Therefore, human factor study was
done to verify the user convenience
of using the meter. Although the
residual risk still exists, it is not in
the non-acceptable region. The
benefit of the meter is to enable the
user to manage their glucose level. It
ultimately contributes to the user's
health.
Therefore the benefits
outweigh this risk. | * BGM-027B-
R009_Human
Factor Study
Report_(Section
012) | Completed |
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Pos
t) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
| H25
Cybersecurity
problem | Bluetooth
connection
between
meter
and
unintended
device | Minor/
Minor | Occasional/
Remote | AFAP
/ACC | Restriction
on
display time of
showing
Passkey | When
Bluetooth
connection
between the meter and unintended
device is complete, there is a risk
that user can be damaged by
cybersecurity problem. Therefore,
Passkey entry and short display time
of showing Passkey was adopted to
prevent that situation and software
function test was done to verify this.
Also counter measure to lower
probability of the risk has been done
by adding explanation in user
manual. The meter was designed
meeting Bluetooth SIG standard and
it was described in Bluetooth
communication protocol. Therefore
the residual risk falls from AFAP to
ACC region. Although the residual
risk still exists, it is not in the non-
acceptable region. The benefit of the
meter is to enable the user to manage
their glucose level. It ultimately
contributes to the user's health.
Therefore the benefits outweigh this
risk. | BGM-018B-
R021_Software
Function Test
(Section 016) | Completed |
| H25
Cybersecurity
problem | Data
transmission
without data
encryption | Minor
/Minor | Remote
/Improbable | ACC
/ACC | Product
design
which
meets
Bluetooth
SIG
standard | When data is exposed while meter
transmits the data, there is a risk that
damaged
user
can
be
by
cybersecurity problem. Therefore
the meter was designed meeting
Bluetooth SIG standard and it was
described
in
Bluetooth
communication
protocol.
Also,
Bluetooth SIG certification was
received.
This
verifies
that | Bluetooth
SIG
certification | Completed |
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Pos
t) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
| | | | | | | | | |
| H25
Cybersecurity
problem | Outside
intrusion
during UART
communicati
on | Minor
/Minor | Occasional
/Remote | AFAP
/ACC | Connect with a
device using the
protocol
designed by i-
SENS, Inc.
(BGM-TCF-14-
025_Communic
ation
Protocol
for UART) | Outside intrusion during UART
communication, there is a risk that
user can be damaged. To reduce the
risk, the meter connects with other
device one-to-one and only use the
communication protocol designed
by i-SENS, Inc.
Therefore the residual risk falls from
AFAP to ACC region. Although the
residual risk still exists, it is not in
the non-acceptable region. The
benefit of the meter is to enable the
user to manage their glucose level. It
ultimately contributes to the user's
health.
Therefore
the benefits
outweigh this risk. | User Manual
pg. 10, 41 | Completed |
| H16
Software
problem | Error
of
download
function using
UART
communicati
on | Minor | Occasional/
Remote | AFAP/
ACC | Memory Test | When software fails to download the
data properly, there is a risk of user
inconvenience. Therefore, memory
test was done to verify the memory
function of the meter and lower the
probability of the risk. Therefore the
residual risk falls from AFAP to
ACC region Although the residual
risk still exists, it is not in the non-
acceptable region. The benefit of the | BGM-027B-
R023_3_Memory
Test | Complete |
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Pos
t) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
| | | | | | | meter is to enable the user to manage
their glucose level. It ultimately
contributes to the user's health.
Therefore the benefits outweigh this
risk. | | |
| H4
Electromagnetic
field
compatibility | Electromagne
tic field effect
during
Bluetooth
communicati
on | Minor
/Minor | Occasional
/Remote | AFAP
/ACC | EMC test report
Caution
indication
(Manual) | When meter is exposed to
electromagnetic field, there is a risk
of meter's damaging and
malfunction. Therefore, counter
measure to lower the probability of
the risk has been done by adding
related caution indication phrase in
the user manual. Therefore the
residual risk falls from AFAP to
ACC region. Although the residual
risk still exists, it is not in the non-
acceptable region. The benefit of the
meter is to enable the user to manage
their glucose level. It ultimately
contributes to the user's health.
Therefore the benefits outweigh this
risk. | EMC Test report
(NK-15-E-0779)
Caution indication
(Manual) | Complete |
| H4
Electromagnetic
field
compatibility | Electromagne
tic field effect
during
Bluetooth
communicati
on | Minor | Occasional/
Remote (2) | AFAP/
ACC | SIG Certificate
FCC Part 15
Subpart B &
Part 2
EMC Safety
Test
IEC 60601-1-2:
2007,
EN 60601-1-
2:2007/AC:201
0
IEC 61010- | When meter is exposed to
electromagnetic field, there is a risk
of meter's damaging and
malfunction. Therefore, R&TTE
and FCC test was done to verify that
there is no problem of meter's
electromagnetic field effect and
lowers the probability of the risk.
Also, counter measure to lower the
probability of the risk has been done
by adding related caution indication
phrase in the user manual. Therefore
the residual risk falls from AFAP to
ACC region. Although the residual | Qualified SIG
Design ID: 78922
FCC
(NK-15-E-0781(i-
Sens_GM01BAB)
_FCC)
EMC
(NK-15-E-0779)
Safety
(KR-KETI2885) | Complete |
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Pos
t) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
| | | | | | 1:2010, IEC
61010-2-
101:2015 | risk still exists, it is not in the non-
acceptable region. The benefit of the
meter is to enable the user to manage
their glucose level. It ultimately
contributes to the user's health.
Therefore the benefits outweigh this
risk. | | |
| H2
User errors
and/or
unawareness | Difficulties of
performing
Bluetooth
pairing
process | Minor | Probable
Remote | AFAP
ACC | Use instruction | When user fails to transfer meter
data to his/her device via Bluetooth
connection, there is a risk of user
inconvenience. Therefore, counter
measure to lower the probability of
the risk has been done by adding use
instruction in the user manual.
Therefore the residual risk falls from
AFAP to ACC region. Although the
residual risk still exists, it is not in
the non-acceptable region. The
benefit of the meter is to enable the
user to manage their glucose level. It
ultimately contributes to the user's
Therefore
health.
the benefits
outweigh this risk. | User manual, pg. 37
Additional
Bluetooth pairing
quick guide
Proposed labeling) | Complete |
| HI Q
Software
problem | of
Error
download
function using
Bluetooth
communicati
on | Minor | Occasional
Remote | AFAP
ACC | Memory test | When software fails to download the
data properly, there is a risk of user
inconvenience. Therefore, memory
test was done to verify the memory
function of the meter and lower the
probability of the risk. Therefore the
residual risk falls from AFAP to
ACC region Although the residual
risk still exists, it is not in the non-
acceptable region. The benefit of the
meter is to enable the user to manage
their glucose level. It ultimately | BGM-027B-
R023_3_Memory
l'est | Complete |
| Potential
Hazard | Potential
cause(s) | Severity
(Pre/
Post) | Likelihood
(Pre/Post) | Risk
(Pre/Post) | Controls
(Counter
measure) | Risk/Benefit Analysis | Test ID | Completeness
of risk control |
| | | | | | | contributes to the user's health.
Therefore the benefits outweigh this
risk. | | |
10
11
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".
12
13
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".
14
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.