(122 days)
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No
The document describes a standard electrochemical blood glucose monitoring system with a speaking function, but there is no mention of AI or ML technology being used for data analysis, interpretation, or any other function.
No
The device is described as a blood glucose monitoring system intended for quantitative measurement of glucose, which aids in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis or screening of diabetes, nor does it treat or prevent disease.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not for the diagnosis or screening of diabetes." Its purpose is aiding in monitoring the effectiveness of diabetes control, not diagnosing a condition.
No
The device description explicitly states the system consists of a multi-use blood glucose meter, 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 / Indications for Use" section explicitly states that the system is intended for use outside the body (in vitro).
- Measurement of Glucose in Blood: The system measures glucose in fresh capillary whole blood samples. This is a common type of in vitro diagnostic test.
- Aid to Monitor Diabetes Control: The system is used as an aid to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
The description clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CareSens N Voice Multi 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 system is intended for use outside the body (in virro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N Voice Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Product codes
NBW, CGA, JJX
Device Description
The CareSens N Voice Multi Blood Glucose Monitoring System (BGMS) consists of a multi use blood glucose meter, test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).
The CareSens N Voice Multi BGMS are 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
multiple-patient use in professional healthcare settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Disinfection study was performed on the meter 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. We have also demonstrated that 10,950 each of cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 3 years of multiple-patient use has no effect on the performance or the external materials of the meter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows a logo with the text "i-sens". The "i" is stylized with a circle above it, and the text is in a bold, sans-serif font. The logo appears to be for a company or organization named i-sens. The image is in black and white.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
510(k) Summary NOV 22222013
(As required by 21 CFR 807.92)
| Introduction | According to the requirements of 21 CFR 807.92, the following information |
|---|---|
| provides sufficient detail to understand the basis for a determination of | |
| substantial equivalence. | |
| Type of 510(k) | Special 510(k) |
| Submitter | i-SENS, Inc. |
| Information | 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea |
| Tel.) +82-33-903-0767 | |
| Fax) +82-33-748-6191 | |
| e-mail: cylim@i-sens.com | |
| Contact Person: Chae Yun Lim | |
| Prepared Date | July 22, 2013 |
| Device Name | Trade name: CareSens N Voice Multi Blood Glucose Monitoring System |
| and | Common name: Blood Glucose Test System |
| Classification | Classification product code: NBW, CGA |
| Regulation number: 21 CFR 862.1345 Glucose Test System | |
| Classification panel: 75, Chemistry | |
| Device class: Class II | |
| Predicate Device | Device name: CareSens N Voice Blood Glucose Monitoring System |
| Information | 510(k) number: K121133 |
| Device | The CareSens N Voice Multi Blood Glucose Monitoring System (BGMS) consists |
| Description | of a multi use blood glucose meter, test strips, and control solutions with two |
| different glucose concentrations ("Control A" and "Control B" ranges, sold | |
| separately). | |
| The CareSens N Voice Multi BGMS are 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. | |
| Intended Use: | The CareSens N Voice Multi 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 system is intended for use outside the body ( in vitro ) and | |
| is intended for multiple-patient use in professional healthcare settings as an aid to | |
| monitor the effectiveness of diabetes control. The system is only used with auto- | |
| disabling, single use lancing device. It is not intended for use on neonates and is | |
| not for the diagnosis or screening of diabetes. | |
| The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N | |
| Voice Multi Blood Glucose Meter to quantitatively measure glucose in fresh | |
| capillary whole blood samples drawn from the fingertips and alternative sites. | |
| Comparison to | |
| the Predicate | |
| Device | The candidate device and the predicate device consist of the same meter and test |
| strips. And the measurement principle, fundamental scientific technology, | |
| operating ranges, and performance characteristics of the candidate device are the | |
| same as those of the predicate device. However, they have separate names because | |
| of the different indications for use (single- vs. multiple-patient use). Also, there | |
| are some label changes made in accordance with the changed indications for use. | |
| 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 electrical current to glucose | |
| concentration. | |
| Summary of | |
| Pre-cleaning | |
| and Disinfection | The device is intended for multiple patients use in a professional healthcare |
| setting. Disinfection study was performed on the meter 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. | |
| We have also demonstrated that 10,950 each of cleaning and disinfection cycles | |
| for meter with the same disinfectant designed to simulate 3 years of multiple- | |
| patient use has no effect on the performance or the external materials of the meter. | |
| Conclusion | Based on the submitted information in this premarket notification, the |
| candidate device is substantially equivalent to the predicate device. Further, | |
| the candidate device has met the performance, safety, and effectiveness of the | |
| device for its intended use. |
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Image /page/1/Picture/0 description: The image shows a logo with the text "i-sens" in a bold, sans-serif font. The "i" in "i-sens" is stylized with a circular design above it, resembling a target or a stylized eye. The logo appears to be for a company named i-sens.
·
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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person with outstretched arms, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be of low resolution.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
I-SENS, INC. CHAE YUN LIM 27-36 GWANGUN-RO. NOWON-GU SEOUL 139-845 KOREA
Re: K132288
Trade/Device Name: CareSens N Voice Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: October 23, 2013 Received: October 28, 2013
Dear Chae Yun Lim:
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. Iisting 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 (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.
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Page 2-Chae Yun Lim
: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
s s s s s s
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Carol C. Benson -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
4
Indications for Use Form
510(k) Number (if known): _ K132288
Device Name: CareSens N Voice Multi Blood Glucose Monitoring System
Indications for Use:
The CareSens N Voice Multi 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 system is intended for use outside the body (in virro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N Voice Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The meter has a speaking function but it is not intended for use by the visually impaired persons.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
Stayce Beck
510(k)
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