(312 days)
The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.
The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
This 510(k) summary (K103396) describes the COOL Blood Glucose Monitoring System, which is substantially equivalent to the predicate CareSens N Blood Glucose Monitoring System (K083468). The modifications in the COOL system are limited to the meter's outer casing design and the test strip's electric connector pattern.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes two performance studies: Repeatability Test (PE-01) and Linearity Study (PE-03). The studies were conducted to verify the proper operation of the modified electric connector of the COOL test strip with the COOL meter.
Repeatability Test (PE-01):
| Interval | Mean Concentration (mg/dL) | Acceptance Criteria | Reported Performance | Met Acceptance Criteria? |
|---|---|---|---|---|
| 1 | 30 to 50 | SD < 7.7 mg/dL | (Not explicitly stated, but reported as "Yes") | Yes |
| 2 | 51 to <100 | SD < 7.7 mg/dL | (Not explicitly stated, but reported as "Yes") | Yes |
| 3 | 111 to 150 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| 4 | 151 to 250 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| 5 | 251 to 400 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| >= 100 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
Linearity Study (PE-03):
| Item | Acceptance Criteria | Reported Performance | Met Acceptance Criteria? |
|---|---|---|---|
| Correlation coefficient (r) | $\ge$ 0.97 | (Not explicitly stated, but reported as "Yes") | Yes |
| Bias: Linear equation | |||
| A (slope) | 0.95 < A < 1.05 | (Not explicitly stated, but reported as "Yes") | Yes |
| B (y-intercept) | -5 < B < 5 | (Not explicitly stated, but reported as "Yes") | Yes |
The document states, "The test results confirmed that the modified electric connector of the strip operated properly with the meter. Thus, COOL BGMS demonstrated satisfactory performance and is suitable for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the repeatability and linearity tests (PE-01 and PE-03).
The data provenance (e.g., country of origin, retrospective or prospective) for these specific tests is not provided. However, the applicant and manufacturer, i-SENS, Inc., are located in Seoul, Korea, implying the studies were likely conducted there.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is Not Applicable as the studies described (repeatability and linearity of a blood glucose meter) are analytical performance studies. They involve quantitative measurements against a reference method or known concentrations, not qualitative assessments requiring expert interpretation like in image-based diagnostic systems. Therefore, experts for establishing ground truth in the context of diagnostic interpretation are not relevant here.
4. Adjudication Method for the Test Set
This section is Not Applicable for the same reasons as in point 3. Analytical performance testing does not involve adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The submission focuses on the analytical performance of a blood glucose monitoring system, not on diagnostic accuracy involving human readers.
6. Standalone Performance Study
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was done. The repeatability and linearity tests described are standalone analytical performance studies of the device's ability to accurately and precisely measure glucose concentrations.
7. Type of Ground Truth Used
For the repeatability and linearity tests:
- Repeatability: The ground truth would typically be the mean of multiple measurements of a known glucose concentration or a control solution.
- Linearity: The ground truth would be a series of known glucose concentrations (e.g., prepared standards or reference materials) spanning the measuring range of the device.
The document does not explicitly detail the specific reference methods or the exact nature of the "mean concentration (mg/dL)" used, but implicitly, these are based on accurately prepared reference samples.
8. Sample Size for the Training Set
The document describes performance verification studies for a modified version of an existing device. It does not mention a training set, as it is not a machine learning or AI-based product in the context of image analysis requiring a distinct training phase. These are analytical performance studies.
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable as there is no mention of a training set for machine learning or AI algorithm development in this 510(k) submission. The studies presented are analytical performance tests for a blood glucose monitoring system.
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i-sens
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
SEP 2 7 2011
510(k) Summary
(As required by 21 CFR 807.87)
According to the requirements of 21 CFR.807.92, the following information Introduction: provides data needed to understand the basis for determining substantial equivalence.
510(k) Number is: K103396
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
Martin Saperstein Contact Person: GOODMAN & SAPERSTEIN Tel.) 1-516-227-2100 Fax) 1-516-227-2108
COOL Blood Glucose Monitoring System Device Name: Trade name: Glucose Test System Common Name:
| DeviceClassification: | Product Code | Classification | RegulationSection | Panel |
|---|---|---|---|---|
| CGA - glucose oxidase,glucose | Class II | 21 CFR862.1345 | 75,Chemistry | |
| NBW - system, test, bloodglucose, over the counter | Class II | 21 CFR862.1345 | 75,Chemistry |
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i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
- COOL Control Solution
| Product Code | Classification | RegulationSection | Panel |
|---|---|---|---|
| JJX - Quality control material | Class I | 21 CFR862.1660 | 75,Chemistry |
Quantitative, Amperometric method Type of Test: Enzyme: Glucose oxidase (Aspergillus sp.)
System Description: The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
The COOL Blood Glucose Meter is intended for use with the COOL Blood Intended Use: Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steadystate blood glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.
| Predicate Device: | Device name: | CareSens N Blood Glucose Monitoring System |
|---|---|---|
| 510(k) Number: | K083468 |
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Image /page/2/Picture/0 description: The image shows a logo with the text "i-sens" in a stylized font. The "i" is lowercase and has a small circle above it, resembling a dot. The "sens" part of the word is in a bold, rounded font. The entire word is enclosed within a partial circle, which starts above the "i" and curves around the word, ending near the bottom of the "s".
i-SENS, Inc. Tel. 82-2-916-6191 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
| Comparison with | The modified COOL BGMS has the following similarities to the predicate |
|---|---|
| Predicate Device: | device: |
| 1) same intended use, | |
| 2) same operating principle, | |
| 3) same fundamental scientific technology, | |
| 4) same product specifications, | |
| 5) same operating ranges, | |
| 6) manufactured by the same process. | |
| The modifications from the predicate device are as follows: |
l ) Meter outer casing design change,
- Electric connector pattern of test strip change.
The COOL BGMS has the same fundamental scientific technology as the Technological predicate CareSens N BGMS. Characteristics:
The all specifications of the COOL BGMS are identical the CareSens N Assessment of Performance: BGMS. The differences are only the physical design of meter and electric connector pattern of the test strip. Accordingly, the performance evaluations such as altitude, hematocrit studies were not conducted. But, to verify whether the modified electric connector of COOL test strip operates properly with the COOL meter, the repeatability and linearity tests were conducted. The test results confirmed that the modified electric connector of the strip operated properly with the meter. Thus, COOL BGMS demonstrated satisfactory performance and is suitable for its intended use.
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| Report No. &Title | Pre-determined Acceptance Criteria | Met pre-determinedacceptance criteria? | |||
|---|---|---|---|---|---|
| PE-01RepeatabilityTest | Interval | Mean concentration(mg/dL) | Yes | ||
| 1 | 30 to 50 | ||||
| 2 | 51 to <100 110 $\ge$ 100 | ||||
| Acceptance criteria | |||||
| 3 | 111 to 150 | ||||
| 4 | 151 to 250 | ||||
| 5 | 251 to 400 | SD<7.7 mg/dL | |||
| SD<7.7 mg/dL | |||||
| CV<7.5% | |||||
| CV<7.5% | |||||
| CV<7.5% | |||||
| CV<7.5% | |||||
| PE-03LinearityStudy | Item | Yes | |||
| Correlation coefficient (r) | |||||
| Bias: Linear equation(y = Ax + B) | |||||
| Acceptance criteria | |||||
| $\ge$ 0.97 | |||||
| 0.95 < A < 1.05 | |||||
| -5 < B < 5 |
Conclusion:
The modifications of COOL BGMS do not affect the safety and effectiveness of the device and the intended use. Therefore, based on the information provided in this submission, the COOL BGMS is substantially equivalent to the predicate CareSens N BGMS.
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MEMO TO FILE
| DATE: | October 5, 2011 |
|---|---|
| TO: | File |
| RE: | K103396, Product Code Correction for iSens COOL Blood Glucose MonitoringSystem |
| FROM: | Christine King, Scientific Reviewer, CDRH/OIVD/DCTD |
A correction letter needs to be sent to the sponsor and the CTS product codes need to be updated. The product code LFR (glucose dehydrogenase) needs to be replaced with CGA (glucose oxidase). The other product codes, NBW and JJX remain the same.
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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centrally aligned. The words are capitalized, and the overall appearance is clean and professional.
Public Health Service
i-Sens, Inc. c/o Goodman and Saperstein 100 Garden City Plaza, Suite 412B Garden City, NY 11530
Re: K103396
Trade/Device Name: COOL Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: 862.1345, Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: 13 September 2011 Received: 14 September 2011
10903 New Hampshire Avenue Silver Spring, MD 20993
Food and Drug Administration
OCT - 5 2011
Dear Mr. Saperstein:
This letter corrects our substantially equivalent letter of September 27, 2011.
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Patri 2011 796.
5450 - Also, please note the county of the cities 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/Medicallers/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 the Act Tribution of Scription of Stories number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. 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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Indications for Use Form
510(k) Number (if known): K103396
Device Name: COOL Blood Glucose Monitoring System
Indications for Use:
The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forgaraoson m thigh and calf. The alternate site testing should be used only during steady-starts plonny, glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.
| Prescription Use(Part 21 CFR 801 Subpart D) | _____________________________________________________________________________________________________________________________________________________________ |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | X_____________________________________________________________________________________________________________________________________________________________ |
|---|---|
| ------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103396
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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.