(84 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures glucose using electrical current. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as an "aid to monitor the effectiveness of diabetes control," indicating it's a diagnostic or monitoring tool rather than a device that provides therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states "It is not intended for use on neonates and is not for the diagnosis or screening of diabetes." While it aids in monitoring diabetes control, it disclaims diagnostic use.
No
The device description explicitly lists hardware components such as the CareSens N Mini Meter, test strips, control solutions, lancing device, and lancets, indicating it is a hardware-based system with associated consumables.
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) by people with diabetes at home". The term "in vitro" is a key indicator of an IVD.
- Measurement of Analytes: The system is designed for the "quantitative measurement of glucose in fresh capillary whole blood samples". Measuring analytes (like glucose) in biological samples is a core function of IVDs.
- Device Description: The description details a system that analyzes a biological sample (whole blood) using test strips and a meter to determine a medical condition (glucose level related to diabetes).
Therefore, based on the provided information, the CareSens N Mini Blood Glucose Monitoring System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Mini 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
The CareSens N Mini Blood Glucose Monitoring System (BGMS) measures Device Description: the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Mini Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately}, Lancing Device, Lancets, User's Manual, Quick Reference Guide and Logbook.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips and alternative sites such as the forearm, palm, thigh, and calf
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)
The basic features of the CareSens N Mini BGMS are all the same with the predicate device except for the meter's appearance and output value (including the memory capacity). The CareSens N Mini BGMS uses the same test strips (just a different name) and control solutions being used in the CareSens N BGMS. So, its performance, safety and effectiveness have not changed from the predicate device. However, in order to confirm the modifications have not introduced any adverse effect validation testing including the meter function test and system accuracy test were conducted.
And to evaluate the usability the newly designed CareSens N Mini meter, the human factor study were conducted. The result indicates that the modified. meter is as ease to use as the predicate device.
Disinfection studies were performed on the CareSens N Mini meter and lancing device by an outside commercial testing service to determine the robustness of the meter and lancing device to the recommended pre-cleaning and disinfection protocol, and its effectiveness in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12) was validated for 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 designed to simulate 5 years of use has affected neither the performance nor on the external materials for the meter and lancing device.
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
1.20759
Image /page/0/Picture/1 description: The image shows the logo for i-sens. The logo consists of the letter 'i' in lowercase, followed by the word 'sens'. The 'i' has a dot above it, and the entire logo is encircled by a series of concentric arcs, giving the impression of a target or a signal being emitted.
ﺴﻤ
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
JUN - 5 2012
510(k) Summary
(As required by 21 CFR 807.92)
| Type of 510(k): | Special 510(k) |
|---|---|
| Submitted By: | i-SENS, Inc. |
| 465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea | |
| Tel.) +82-2-916-6191 | |
| Fax) +82-2-942-2514 | |
| www.i-sens.com | |
| Contact Person: | Dr. Hyun Joon Oh |
| Tel.) +82-33-903-0760 | |
| Fax) +82-33-748-6191 | |
| e-mail: hjoh@i-sens.com | |
| Prepared Date: | March 9, 2012 |
| Device Name: | Trade name: CareSens N Mini Blood Glucose Monitoring System |
| Common Name: Glucose Test System | |
| Regulatory Information: | 1) Regulation section: 21 CFR 862.1345 Glucose Test System, |
| 21 CFR 862.1660, Quality control material | |
| 2) Classification: Class II, Class I, reserved | |
| 3) Product Code: CGA - glucose oxidase, glucose | |
| NBW - system, test, blood glucose, over the counter | |
| JJX - Quality control material | |
| 4) Panel: Clinical Chemistry (75) |
1
Intended Use: The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steadystate blood glucose conditions. The CareSens N Mini 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
- The CareSens N Mini Blood Glucose Monitoring System (BGMS) measures Device Description: the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Mini Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately}, Lancing Device, Lancets, User's Manual, Quick Reference Guide and Logbook.
Substantial 1) Predicate Device Name: CareSens N Blood Glucose Monitoring System Equivalence Information: 2) Predicate 510(k) Number: K083468
- Comparison with Predicate Device: The modified CareSens N Mini BGMS has the following features that are
ર - 2
2
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
same to the predicate device:
- intended use
- . measurement principle
- 1 fundamental scientific technology
- operating ranges
The modifications on the CareSens N BGMS to make a CareSens N Mini BGMS are:
- The meter appearance, the number of required batteries and memory capacity of the Meter
- 트 Removal of the data transmission, data averaging and meter setting functions
The test strip is the same as that of the predicate system - the only difference is in the name (CareSens N Test Strip vs. CareSens N Single Test Strip).
Type of Test: Quantitative, Amperometric method, Glucose oxidase (Aspergillus sp.)
Test Principle: The reagent on the test strip produces a small electrical current using glucose as a substrate in the blood sample. The Meter converts the electrical current to a concentration of glucose.
Technological The CareSens N Mini BGMS has the same fundamental scientific technology Characteristics: as the predicate device.
The basic features of the CareSens N Mini BGMS are all the same with the Assessment of Performance predicate device except for the meter's appearance and output value (including the memory capacity). The CareSens N Mini BGMS uses the same Characteristics: test strips (just a different name) and control solutions being used in the CareSens N BGMS. So, its performance, safety and effectiveness have not changed from the predicate device. However, in order to confirm the modifications have not introduced any adverse effect validation testing including the meter function test and system accuracy test were conducted.
3
And to evaluate the usability the newly designed CareSens N Mini meter, the human factor study were conducted. The result indicates that the modified. meter is as ease to use as the predicate device.
Summary of Disinfection studies were performed on the CareSens N Mini meter and Pre-cleaning and lancing device by an outside commercial testing service to determine the Disinfection: robustness of the meter and lancing device to the recommended pre-cleaning and disinfection protocol, and its effectiveness in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12) was validated for 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 designed to simulate 5 years of use has affected neither the performance nor on the external materials for the meter and lancing device.
Conclusion:
Based on the information provided in this submission, the CareSens N Mini BGMS is substantially equivalent to the predicate devices. A candidate device CareSens N Mini BGMS has met the performance, safety, and effectiveness of the device for its intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with three curved lines representing its body and wings. The bird is positioned in the center of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the top half of the circle.
10903 New Hampshire Avenue Silver Spring, MD 20993
JUN - 5 2012
i-SENS, Inc. c/o Hyun Joon Oh 465-6 Wolgye-dong, Nowon-gu Seoul Republic of Korea 139-845
K120759 Re:
K120759
Trade Name: CareSens N Mini Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: May 3, 2012 Received: May 8, 2012
Dear Dr. Oh:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your securer sized the device is substantially equivalent (for the It it it is a dove and have acceminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale comments, or to 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 the Federal Pood, Drug, and Cosment . For (+10) ... market the devices subject to the general approval appreation (1 MIT). 1 ou . . - ), The general controls provisions of the Act include condons provisions of the fiction, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified ($60 additional controls. Existing major regulations affecting (PMA), it may be subject to such acantoner over.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partin the Fodors your device can oc found in This 22, Coursements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements meall that IDA has made a determination administered by other Federal agencies. of the Act of ally rederal statutes and regulations. but not limited to: registration You must comply with an the Net Birdger of CFR Parts 801 and 809); medical device and fishing (21 CFR Part 607), labering (21 CFR 803); and good reporting (reporting of medical device relation in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
C. Gary H. Lisc, Ph.D.
Counney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device
Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K 120759
Device Name: CareSens N Mini Blood Glucose Monitoring System
Indications for Use:
The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Mini 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ >