(122 days)
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.
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.
The provided document pertains to a 510(k) submission for the "CareSens N Voice Multi Blood Glucose Monitoring System". This is a regulatory submission for a medical device that measures blood glucose, and the criteria and studies described are for demonstrating substantial equivalence to a predicate device, as opposed to a new AI model with clinical performance studies.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC study, standalone performance, training set) typically applies to more complex AI/ML device submissions, especially those involving image analysis or diagnostic support where a 'ground truth' needs to be established by experts.
For this blood glucose monitoring system, the "performance" is typically assessed through analytical studies demonstrating accuracy against a reference method, rather than through expert adjudication or large scale clinical outcome studies as one might find for an AI diagnostic tool.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document mentions that "the candidate device has met the performance, safety, and effectiveness of the device for its intended use." However, it does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy metrics or ranges) for blood glucose measurement. It also doesn't present a table of reported device performance values against such criteria. The submission focuses more on the equivalence to the predicate device and the disinfection study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for any performance testing of the blood glucose measurement function, nor does it provide details on data provenance (country, retrospective/prospective). The only study detailed is a disinfection study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable to a blood glucose monitoring system in the same way it would be for an AI diagnostic imaging device. Blood glucose measurements are typically compared against a laboratory reference method (e.g., YSI analyzer) rather than expert consensus. The document does not mention any expert involvement in establishing 'ground truth' for glucose measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a blood glucose monitoring system; no adjudication method would be used for this type of device performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a standalone blood glucose meter and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is inherently "standalone" in its function as a blood glucose meter, as it directly measures glucose levels. The document states it is "intended for use outside the body (in vitro)" and "measures the glucose level in whole blood samples." This confirms it operates independently to provide the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for performance evaluation of blood glucose measurement. However, for blood glucose meters, the "ground truth" (or reference standard) is almost universally a highly accurate laboratory method, such as a YSI glucose analyzer.
8. The sample size for the training set:
The concept of a "training set" is typically associated with machine learning or AI models. This device is an electrochemical biosensor, not an AI model, so there isn't a "training set" in that sense.
9. How the ground truth for the training set was established:
Not applicable due to the reasons stated in point 8.
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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 tothe PredicateDevice | The candidate device and the predicate device consist of the same meter and teststrips. And the measurement principle, fundamental scientific technology,operating ranges, and performance characteristics of the candidate device are thesame as those of the predicate device. However, they have separate names becauseof the different indications for use (single- vs. multiple-patient use). Also, thereare 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 asubstrate in the blood sample. The meter converts electrical current to glucoseconcentration. |
| Summary ofPre-cleaningand Disinfection | The device is intended for multiple patients use in a professional healthcaresetting. Disinfection study was performed on the meter by an outside commercialtesting service to evaluate effectiveness of disinfectant, CLOROX GERMICIDALWipes (EPA Reg. No: 67619-12), in preventing the spread of blood-bornepathogens, using hepatitis B virus (HBV). The results demonstrated completeinactivation of live virus inoculated on the materials of the meter.We have also demonstrated that 10,950 each of cleaning and disinfection cyclesfor 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, thecandidate device is substantially equivalent to the predicate device. Further,the candidate device has met the performance, safety, and effectiveness of thedevice 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
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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
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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)
Page 1 of _ l
§ 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.