(232 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No.
This device is an in vitro diagnostic device used for monitoring blood glucose levels, not for treating any condition.
No
The text explicitly states: "It is not for the diagnosis or screening of diabetes." and "It is not intended for use on neonates and is not for the diagnosis or screening of diabetes." This indicates it is for monitoring, not diagnosis.
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).
The Intended Use section explicitly states: "The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)...".
This clearly indicates that the device is designed to be used outside of the body to test samples (blood) for diagnostic purposes (measuring glucose levels).
N/A
Intended Use / Indications for Use
The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens N Premier BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
CareSens N Premier brand of Blood Glucose Monitoring System is designed to have two variation models, CareSens N Premier BGMS and CareSens N Premier BT BGMS. CareSens N Premier BGMS is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, CareSens N Premier BT BGMS is implemented with all of the changes stated in the submission. The two meters use the same CareSens N Single Test Strip and CareSens Control Solution. 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.
CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System consist of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges).
The CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The following items are included in the system starter kit:
- 1 Blood Glucose Meter -
- -10 Blood Glucose Test Strips
- 1 Lancing device -
- -10 Lancets
- 1 Owner's Booklet -
- -1 Quick Reference Guide
- -2 Batteries (3.0V lithium batteries)
The following items are compatible with the CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System and are available separately.
- -CareSens N Single Blood Glucose Test Strips
- -CareSens Glucose Control Solution
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 diagnostic use) 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)
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2017
I-SENS, INC. JOON HO JUNG RA TEAM MANAGER 43, BANPO-DAERO, 28-GIL, SEOCHO-GU 06646, SEOUL, KOREA
Re: K170614
Trade/Device Name: CareSens N Premier Monitoring System CareSens N Premier BT Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: September 18, 2017 Received: September 19, 2017
Dear Joon Ho Jung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stayce Beck -A
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CareSens N Premier Monitoring System
Indications for Use (Describe)
The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
| 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) K170614
Device Name CareSens N Premier BT Monitoring System
Indications for Use (Describe)
The CareSens N Premier BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
| 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. The logo is simple and modern.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
510(k) Summary
(As required by 21 CFR 807.92)
| Introduction: | This summary of 510(k) information is being submitted in accordance
with requirements of 21 CFR Part 807.92. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k): | Special 510(k) |
| 510k Number | K170614 |
| Submitter Information: | i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
Tel.) +82-2-916-6191
Fax) +82-2-942-2514
e-mail: jhjung@i-sens.com
Contact Person: Joon Ho Jung |
| Prepared Date: | February, 24th, 2017 |
| Device Name | CareSens N Premier Blood Glucose Monitoring System
CareSens N Premier BT Blood Glucose Monitoring System |
| Classification Name | Blood Glucose Test System |
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW | Class II | 21 CFR 862.1345 | |
| Blood Glucose Test System | Clinical Chemistry 75 |
Predicate Device NoCoding1 Plus Blood Glucose Monitoring System, K160742.
Device Description CareSens N Premier brand of Blood Glucose Monitoring System is designed to have two variation models, CareSens N Premier BGMS and CareSens N Premier BT BGMS. CareSens N Premier BGMS is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, CareSens N Premier BT BGMS is implemented with all of the changes stated in the submission. The two meters use the same CareSens N
5
Image /page/5/Picture/0 description: The image shows the logo for i-sens. The "i" is blue with a green dot above it, and the word "sens" is in blue. The logo is simple and modern.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
Single Test Strip and CareSens Control Solution. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device. NoCoding1 Plus Blood Glucose Monitoring System, K160742.
CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System consist of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges).
The CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The following items are included in the system starter kit:
- 1 Blood Glucose Meter -
- -10 Blood Glucose Test Strips
- 1 Lancing device -
- -10 Lancets
- 1 Owner's Booklet -
- -1 Quick Reference Guide
- -2 Batteries (3.0V lithium batteries)
The following items are compatible with the CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System and are available separately.
- -CareSens N Single Blood Glucose Test Strips
- -CareSens Glucose Control Solution
Intended Use: The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates
6
Image /page/6/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for two green dots. The first green dot is above the "i" and the second green dot is to the left of the "s".
i-SENS. Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens N Premier BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
Comparison to the Cleared Device
The modifications are as below:
-
- Change in the housing case of the meter
- -Button positioning from the sides to the front of the meter (PC to Silicone Rubber).
- -The material of the meter screen changed from PC to PMMA.
- -Addition of ejection button (new material: POM).
- -The material of the foot of the meter from TPU to TPE.
- Meter shell color -
- Addition of backlight to meter screen -
-
- Trade name of the system changed from NoCoding1 Plus Blood Glucose Monitoring System to CareSens N Premier and CareSens N Premier BT Blood Glucose Monitoring System.
-
- Addition of Bluetooth module to the meter for wireless data transfer to mobile devices (applies to GM01AAB only). The CareSens N Premier BT (GM01AAB) meter can communicate with smart devices such as a smart phone or a tablet by SmartLog App. The unmodified device K 160742
7
Image /page/7/Picture/0 description: The image shows the logo for i-sens. The logo is written in a sans-serif font, with the "i" in green and the rest of the word in blue. The "i" has a green circle above it, and a green dot below it. The logo is simple and modern.
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
already had the data transfer function of transmitting the stored information to PC via a USB cable.
Other than these modifications, the following remains the same to the cleared device:
- -Has the same intended use,
- Uses the same operating principle, -
- Utilizes the same use environment and calibration method. -
8
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
| Comparison to the Predicate Device | ||
|---|---|---|
| Characteristic | Predicate Device | |
| NoCoding1 Plus Blood Glucose Monitoring System, K160742 | Candidate Device | |
| CareSens N Premier Blood Glucose Monitoring System | ||
| CareSens N Premier BT 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. | 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
- Hexaamineruthenium(III) chloride: 45.7 µg
- Other ingredients: 1.6 µg | Same |
| Measurement Principle | Amperometric method | Same |
| Sample type | Fresh capillary whole blood | Same |
| Calibration | Plasma-equivalent | Same |
| Coding system | No coding required (Automatic code identification) | Same |
| Test time (sec.) | 5 | Same |
| Sample volume (ul) | 0.5 | Same |
| Measurement unit | mg/dL | Same |
| Test range (mg/dL) | 20-600 | Same |
| Operating Humidity | 1090% | Same |65 | 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
9
i·sens
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
10
Image /page/10/Picture/0 description: The image shows the logo for i-sens. The logo is in blue, except for a green dot above the 'i'. The text is in lowercase and has a modern, sans-serif font. The logo is simple and clean, and it is likely used to represent the company's brand.
i-SENS. Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
Performance Data
Non-clinical
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Cleaning and Disinfection
The device is intended for single patient home use. Disinfection studies were performed on the meter and lancing device by an outside commercial testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12), in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). The results demonstrated complete inactivation of live virus inoculated on the materials of the meter and lancing device. We have also demonstrated that 260 each of pre-cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 5 years (260 each of pre-cleaning and disinfection cycles for meter and lancing device) of single patient device use has no effect on the performance or the external materials of the meter and lancing device.
Conclusion
Based on the submitted information in this premarket notification, the candidate devices are substantially equivalent to the predicate device.