(198 days)
The CareSens II, CareSens POP Meters are used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareSens Test Strips work with the CareSens II, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.
CareSens Blood Glucose Monitoring System is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens Test Strips. The CareSens II model consists of the CareSens II meter, CareSens test strips, CareSens control solution (Normal and Middle ranges), check strips, lancing device, lancets, user manual, quick reference guide and a logbook. CareSens POP model consists of the CareSens POP meter, CareSens test strips and lancing device, lancets, user guide, and quick guide.
The test principle is:
CareSens Blood Glucose Monitoring System is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase. A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
The provided text describes a 510(k) summary for the CareSens Blood Glucose Monitoring System, which includes information about its intended use, principle of operation, and a comparison to a predicate device. It also mentions a substantial equivalence claim based on clinical data. However, the document does NOT contain explicit acceptance criteria, detailed study design, sample sizes for test and training sets, information about experts, adjudication methods, MRMC studies, or specific ground truth establishment methods as requested in the prompt.
Therefore, many of the requested items cannot be extracted directly from the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All predetermined acceptance criteria were satisfied." However, the specific acceptance criteria themselves are not detailed in the provided text. The document implies that the device performance was sufficient to demonstrate substantial equivalence to the predicate device. Without the actual acceptance criteria, a table cannot be fully populated.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "All predetermined acceptance criteria were satisfied." The device performed "well with the laboratory glucose reference test equipment." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The study is described as "clinical data." The submitting company is i-SENS, Inc. in Seoul, Korea, suggesting the data may originate from Korea, but this is not explicitly stated as the country of origin for the data used in the clinical study. It is implied to be a prospective study ("The clinical data demonstrates the performance..."), but not explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The "ground truth" is referred to as "laboratory glucose reference test equipment," implying a comparison against a gold standard lab method, not expert consensus.
4. Adjudication method for the test set:
- Not applicable as the ground truth appears to be established by comparison to laboratory equipment, not by human expert consensus or adjudication.
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 blood glucose monitoring system, an in-vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "CareSens Blood Glucose Monitoring System" is an automated device designed to measure glucose concentration. The performance described is that of the device itself, functioning as an algorithm/instrument without direct human interpretation in the loop after the sample is applied. The statement "The clinical data demonstrates the performance of the CareSens Blood Glucose Monitoring System well with the laboratory glucose reference test equipment" refers to its standalone performance.
7. The type of ground truth used:
- "Laboratory glucose reference test equipment." This indicates a comparison against a recognized gold standard method for glucose measurement in a clinical laboratory setting.
8. The sample size for the training set:
- Not specified in the provided text. Blood glucose monitoring systems typically don't have "training sets" in the AI/machine learning sense, but undergo extensive calibration and verification during development. If "training set" refers to samples used for initial calibration or optimization of the device's measurement algorithm, that information is not provided.
9. How the ground truth for the training set was established:
- Not specified. As noted above, the concept of a "training set" with ground truth in the AI sense is not directly applicable to this type of device based on the provided information.
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i-SENS, Inc. I Sens 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
510(k) SUMMARY
(As required by 2I.CFR.807.92)
OCT 1 7 2008
| Type of 510(k): | Traditional |
|---|---|
| Introduction: | According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence. |
| Submitted By: | i-SENS, Inc.465-6, Wolgye-dong, Nowon-gu, Seoul, 139-845, KoreaTel.) ++82-2-916-6191Fax) ++82-2-942-2514www.i-sens.com |
| Contact Person: | Dr. Hyun Joon Oh, Phone: +82-33-903-0760. Fax +82-33-748-6191 |
| Date Summary,Prepared: | March 18, 2008 |
| Device Name: | Trade name: CareSens Blood Glucose Monitoring SystemCommon Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the OneTouch® Ultra® fromLifeScan, Inc., |
| Device Description: | CareSens Blood Glucose Monitoring System is an in vitro diagnosticdevice designed to measure the concentration of glucose in capillarywhole blood with CareSens Test Strips. The CareSens II model consistsof the CareSens II meter, CareSens test strips, CareSens control solution |
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510(k) Summary, Continued
(Normal and Middle ranges), check strips, lancing device, lancets, user manual, quick reference guide and a logbook. CareSens POP model consists of the CareSens POP meter, CareSens test strips and lancing device, lancets, user guide, and quick guide.
The test principle is:
CareSens Blood Glucose Monitoring System is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase. A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Intended Use:
The CareScns II, CarcSens POP Meters are used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites such as forcarm, palm, thigh and calf.
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510(k) Summary, Continued
CareSens Test Strips work with the CareSens II, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites such as forearm, palm, thigh and calf.
CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.
Comparison to The i-SENS, Inc. CareSens Blood Glucose Monitoring System is Predicate Device: substantially equivalent to the other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed item, the OneTouch® Ultra® by LifeScan, Inc.
Predicate Device 510(k) number: K024194
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Enzyme | Glucose Oxidase | |
| Measurement principle | Amperometric method | |
| Test principle | Glucose Oxidase chemical reaction. The instrument measures theextent of current cause by presence of glucose in sample. | |
| Intended use | The test strips work with the device to quantitatively measureglucose in whole blood. The test Strips are for in vitro (i.e., outside |
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I sens Tel. 82-2-916-6191
510(k) Summary, Continued
Similarities:
| the body) diagnostic use only. | |
|---|---|
| Coding System | Button |
| Sample | Fresh capillary whole blood |
| Electrode | Carbon |
| Calibration | Plasma-equivalent |
| Test Time | 5sec |
| Test Range(mg/dL) | 20~600 |
| Glucose unites | Either mg/dL or mmol/L |
| Checking the system | Control solution |
| Alternate Site Capability | Yes |
| Operating Humidity | 10~90% |
| Data demonstratingSubstantialequivalence: | The clinical data demonstrates the performance of the CareSens BloodGlucose Monitoring System well with the laboratory glucose referencetest equipment. All predetermined acceptance criteria were satisfied. Thedata also demonstrate that the CareSens Blood Glucose MonitoringSystem is substantially equivalent to the predicate device. |
|---|---|
| Conclusion: | CareSens Blood Glucose Monitoring System is substantially equivalentto the following predicate device system: K024194- LifeScan, Inc. OneTouch® Ultra® Blood Glucose Monitoring System. |
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
I-Sens, Inc. c/o Hyun Joon Oh Division Manager, Quality Assurance 465-6 Wolgye-Dong, Nowon-Gu Seoul, Republic of Korea 139-845
OCT 7 7 2008
K080923 Trade Name: CareSens Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: August 25, 2008 Received: August 25, 2008
Dear Hyun Joon Oh:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (K080923):
Device Name: CareSens Blood Glucose Monitoring System
Indication For Use: The CareSens II, CareSens POP Meters are used for the quantitative mcasurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareScns Test Strips work with the CareSens II, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-off
Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080923
§ 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.