(157 days)
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
The Easy Pain Supreme Self-Monitoring Blood Glucose System consists of the Easy Pain Supreme meter, Easy Pain Supreme Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, and Control Solution.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state formal "acceptance criteria" in a separate section. Instead, the performance characteristics are presented as findings from analytical and comparison studies. The implicit acceptance criteria are that the device's performance should be comparable to or within acceptable limits relative to the predicate device and established analytical standards. Below is a summary of the key performance metrics reported:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision (Within-Run) | Low CV% for various glucose concentration levels. (Generally, CV% < 5% is good for low concentrations, higher for higher concentrations) | Level 1 (40-50 mg/dL): CV 4.3% |
| Level 2 (51-110 mg/dL): CV 3.5% | ||
| Level 3 (111-150 mg/dL): CV 3.3% | ||
| Level 4 (151-250 mg/dL): CV 3.1% | ||
| Level 5 (251-400 mg/dL): CV 3.3% | ||
| Precision (Day-to-Day) | Low CV% for control solutions. | Low (56 mg/dL): CV 5.6% |
| Normal (129 mg/dL): CV 3.5% | ||
| High (388 mg/dL): CV 2.6% | ||
| Linearity/Reportable Range | Demonstration of linear relationship between measured and actual glucose concentrations over the claimed range. R² close to 1.0. | Range: 40-600 mg/dL (2.2-33.3 mmol/L) |
| Regression: Y=0.9589x + 6.1617 | ||
| R² = 0.9958 | ||
| Syx = 10.14 | ||
| Traceability | Referenced to recognized standards. | Referenced to NBS, NIST Standards (via CAS# and MDL# Glucose). |
| Detection Limit | Stated range of measurement. | 40-600 mg/dL (2.2-33.3 mmol/L) |
| Analytical Specificity | Minimal effect from tested interferents. | Interference testing conducted, results imply acceptable specificity (no specific values given to compare against for this summary). |
| Method Comparison with Predicate Device | High correlation with a reference method (YSI 2300 Analyzer), slope close to 1.0, y-intercept close to 0. | Slope = 0.967 |
| Y-intercept = 11.98 mg/dL | ||
| Correlation coefficient (r) = 0.972 | ||
| Range tested = 33-514 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- Analytical Performance (Precision/Reproducibility):
- Within-Run Precision: 5 different glucose concentration levels were tested. Each sample was measured 5 times. The table indicates "No. of Assay" as 200 for each level, suggesting that for each level, a concentration was prepared, and then multiple aliquots were tested (possibly 5 tests on each of 40 separate preparations or 40 tests on each of 5 preparations, or a combination).
- Day-to-Day Precision: 3 control solutions (Low, Normal, High) were measured twice a day for a month. The "No. of Assay" is 400 for each control solution, indicating a substantial number of measurements over time.
- Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
- Linearity/Assay Reportable Range:
- A total of 210 tests were performed using 5 meters across seven glucose ranges. The regression analysis (N=630) suggests that each test might have involved multiple data points contributing to the regression calculation, or that 'N' refers to the total number of individual measurements collected across all meters and ranges.
- Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
- Method Comparison with Predicate Device:
- Sample Size: 202 subjects with diabetes.
- Data Provenance: The study involved human subjects, implying prospective clinical data collection for this comparison. The statement "derived from a three independent capillary data versus YSI plasma data" suggests data was collected from patients, likely in a clinical setting. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- No information provided about "experts" to establish ground truth in the traditional sense.
- For the analytical and method comparison studies, the "ground truth" was established by:
- Carefully prepared glucose solutions with known concentrations (for precision and linearity).
- The YSI 2300 Analyzer a recognized laboratory reference method, served as the ground truth for the method comparison study. The qualifications of the operators of the YSI 2300 Analyzer are not specified, but it's presumed to be a standard laboratory procedure with qualified personnel.
4. Adjudication Method for the Test Set:
- Not applicable / not mentioned. Since this device is a quantitative blood glucose measuring system, ground truth (reference values) are obtained through precise laboratory methods (YSI 2300 Analyzer, known glucose concentrations) rather than expert interpretation requiring 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 self-monitoring blood glucose system, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or MRMC studies. Its function is to provide a numerical measurement, not an interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this is a standalone device. The performance characteristics (precision, linearity, method comparison) are evaluating the device's direct measurement capabilities. While it's used by individuals with diabetes (human-in-the-loop for using the device), the "performance" described relates solely to the accuracy and reliability of the device's output, independent of human interpretation beyond simply reading the displayed number. The YSI 2300 comparison directly assesses the algorithm/system's ability to match a reference.
7. The Type of Ground Truth Used:
- Analytical Ground Truth:
- Known glucose concentrations for precision and linearity studies (i.e., preparing solutions with specific, verifiable glucose levels).
- YSI 2300 Analyzer results for the method comparison study. The YSI 2300 is considered a laboratory reference method.
8. The Sample Size for the Training Set:
- Not applicable or Not explicitly stated as a separate "training set". This type of medical device (blood glucose meter) typically undergoes rigorous analytical testing and clinical comparison, but the internal algorithms (e.g., for converting electrochemical signal to glucose concentration) are often developed, calibrated, and validated through extensive in-house data and engineering processes rather than a distinct "training set" in the machine learning sense for submission. The provided summary focuses on validation data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable or Not explicitly detailed. As mentioned above, the development and calibration of the device's internal algorithms would likely use established chemical principles and controlled experiments with known glucose concentrations, similar to how the analytical ground truth was established for the performance studies. However, the exact process for "training" or calibrating the device during its development phase is not outlined in this 510(k) summary.
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510(K) SUMMARY
APR 2 9 2005
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1.0 Submitter's Name: | EPS Bio Technology Corp. |
|---|---|
| Address: | 2F, No.49-2, Lane 2, Guang Fu Rd., Sec. 2, Hsinchu City ,Taiwan, R.O.C. |
| Phone: | 886-3-5752522 |
| Fax: | 886-3-5752552 |
| Contact: | Mr. Y.C. Lei, General Manager |
| 2.0 Device Name: | A. Easy Pain Supreme Self-Monitoring Blood Glucose System |
| 3.0 Classification: | Class II |
| 4.0 Predicate Device: | The predicate device is the Precision® QID Blood Glucose TestingSystem (K 971812) marketed by Medisense Inc. |
| 5.0 Device Description: | The Easy Pain Supreme Self-Monitoring Blood Glucose Systemconsists of the Easy Pain Supreme meter, Easy Pain SupremeGlucose Test Strips, Auto-Lancet Device, Check Strip, Code Card,and Control Solution. |
| 6.0 Indication for Use: | The Easy Pain Supreme Self-Monitoring Blood Glucose System isused by individuals with diabetes. It is for the quantitativemeasurement of glucose levels in fresh capillary whole blood, asan aid in monitoring the effectiveness of diabetes management inthe home and in clinical settings. |
| Special condition for use statement(s) :Provides plasma equivalent results. | |
| Special instrument Requirements : N/A |
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7.0 Comparison with predicate :
| Similarities | ||
|---|---|---|
| Item | Device | Predicated |
| Easy Pain Supreme | Precision QID | |
| Detection method | Amperometry : current isgenerated by oxidation ofreduced mediator. | Amperometry |
| Enzyme | Glucose Oxidase(Aspergillus niger) | Glucose Oxidase(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |
| Differences | ||
|---|---|---|
| Item | Device | Predicated |
| Easy Pain Supreme | Precision QID | |
| Test range | 40-600 mg/dL | 20-600 mg/dL |
| Hematocrit Range | 30-55% | 20-70% |
| Test Time | 25 seconds | 20 seconds |
| Sample Volume | ≥2.0uL | ≥3.5uL |
| Operating Range | ||
| Temperature | 10-40°C | 18-30°C |
| Humidity range | R.H.≤90% | R.H. : 10% to 90% |
| Open use time | 3 months | 3 months |
| Coding | Code Card | Calibrator |
| Memory | 100 blood glucose tests with | NA |
| Capability | Date and time | |
| Power | 1.5V (AAA)*2 batteries | Non-replaceable cell 3.0 V/DC |
| Battery life | Approximately 1,000 glucose tests | Approximately 4,000 glucose tests |
| Size : L x W x H (cm) | 7.5 x 5.4 x 1.9 | 9.7 x 4.80 x 1.45 |
| Weight | 50g (without batteries) | 39.35gram |
The Easy Pain Supreme Self-Monitoring Blood Glucose System employs 8.0 Test Principle a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). 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 glucose concentration is measured by the Easy Pain Supreme Glucose Meter and displayed on the screen after 25 seconds.
FDA 510(K) SUMMARY
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9.0 Performance Characteristics
1. Analytical performance :
Precision / Reproducibility :
Testing was conducted by taking 4 mL of blood that was treated with Heparin through a vacuum tube. Glucose was added to the 4 mL of blood to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 5 times. Below are the glucose concentration ranges for each level that were measured. (See Table I for Summary of Test Results)
| Level | Glucose Concentration Range |
|---|---|
| 1 | 40-50 mg/dL |
| 2 | 51-110 mg/dL |
| 3 | 111-150 mg/dL |
| 4 | 151-250 mg/dL |
| 5 | 251-400 mg/dL |
Three control solutions of Low, Normal and High were prepared. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month. (Table I (below) shows a summary of the Within-Run Precision and the Day-to-Day Precision Tests.)
Table I : Summary of Test Results
| ControlSamples | No. Of Assay | Mean(mg/dL) | SD(mg/dL) | CV(%) |
|---|---|---|---|---|
| Level 1 | 200 | 43 | 2.4 | 4.3 |
| Level 2 | 200 | 95 | 5.3 | 3.5 |
| Level 3 | 200 | 144 | 8.0 | 3.3 |
| Level 4 | 200 | 246 | 13.7 | 3.1 |
| Level 5 | 200 | 398 | 22.1 | 3.3 |
Within-Run Precision
| Day-to-Day Precision | ||
|---|---|---|
| ControlSamples | No. Of Assay | Mean(mg/dL) | SD(mg/dL) | CV(%) |
|---|---|---|---|---|
| Low | 400 | 56 | 3.10 | 5.6 |
| Normal | 400 | 129 | 4.49 | 3.5 |
| High | 400 | 388 | 10.21 | 2.6 |
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9.0 Performance Characteristics(Cont.)
a. Linearity / assay reportable range :
- A blood sample of 25 mL was taken, treated with Heparin vacuum tube, to be set for a day, Testing was performed using whole blood tube, to be set for a Gay, 188.ing to provide samples at seven different supplemented within a total of 210 tests were preformed using 5 meters among the seven glucose ranges per each strip lot. The melers among the coven gide demonstrated the following regression
| mmol/L | mg/dL |
|---|---|
| 2.2- 2.8 | 40- 50 |
| 2.8-4.3 | 51-80 |
| 4.4-6.7 | 81-120 |
| 6.7-11.1 | 121-200 |
| 11.2-16.6 | 201-300 |
| 16.7-22.2 | 301-400 |
| 22.3-33.3 | 400-600 |
Y=0.9589x + 6.1617
R2=0.9958; Syx=10.14; N=630
- b. Traceability (controls, calibrators, or method) : CAS# (Chemical Abstract Service) MDL# (MDL, inc. formerly Molecular Design Laboratories) Glucose #492615 SigmaUltra MFCD00063989 Traceability referenced to NBS, NIST Standards
- c. Detection limit : 40-600 mq/dL 2.2-33.3 mmol/L
- d. Analytical Specifiecity :
Interference testing was conducted to determine the effect of select intonoronoo could exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures of two pools : one at the highest concentration to be tested and the other at the lowest. at the substances and concentrations of the interferents are recommended at NCCLS EP7-P.
- e. Assay cut-off : N/A
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2. Comparison studies :
a. Method comparison with predicate device :
The accuracy of the Easy Pain Supreme Self-Monitoring Blood The accuracy of the Easy Part by comparing blood glucose results. Glucose System was accosse obtained using the YSI 2300 Analyzer. The results below were obtained by 202 subjects with diabetes at The results below were obtained by ssion statistics are derived from a three intoporis capillary data versus YSI plasma data.
The Linear regression of the 202 diabetic patients - YSI 2300 vs. easy Pain Supreme System presented the following regression :
| Slope= | 0.967 |
|---|---|
| y-intercept | 11.98 mg/dL |
| Correlation coefficient(r) | 0.972 |
| No. of samples | 202 |
| Range tested | 33-514 mg/dL |
| Matrix comparison: | N/A |
b. Matrix compariso
3. Clinical studies :
- a_Clinical sensitivity : N/A
- b. Clinical specificity : N/A
- c. Other clinical supportive data (when a and b are not applicable) : See Attachment 12
- N/A 4. Clinical cut-off :
5. Expected Values/Reference range :
Expected blood glucose levels for people without diabetes :
| Time | Range (mg/dL) | Range (mmol/L) |
|---|---|---|
| Before Breakfast : | 70 - 105 | 3.9 - 5.8 |
| Before Lunch orDinner : | 70 - 110 | 3.9 - 6.1 |
| 1 hour after meals : | Less than 160 | Less than 8.9 |
| 2 hour after meals : | Less than 120 | Less than 6.7 |
| Between 2 and 4 AM | Greater than 70 | Greater than 3. |
Where the above Expected Values is referenced from Joslin Diabetes Manual
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8. Conclusions:
The Easy Pain Supreme Self-Monitoring Blood Glucose System have the same intended use and similar technological characteristics as Precision ® QID Blood Glucose Testing System (K 971812) marketed by Medisense Inc.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the Easy Pain Supreme Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devices.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Adrninistration 2098 Gaither Road Rockville MD 20850
APR 2 9 2005
EPS Bio Technology Corp. c/o Ms. Jennifer Reich US Agent Harvest Consulting Corporation 3892 South America West Trail Flagstaff, AZ 86001
K043245 Re:
K043243
Trade/Device Name: Easy Pain Supreme Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 18, 2005 Received: March 25, 2005
Dear Ms. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 3 ro(i) fan device is substantially equivalent (for the indications felerenced above and nave determined and marketed predicate devices marketed in interstate for use stated in the Cherosure) to regars actment date of the Medical Device Amendments, or to commence prov to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in assessor al of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The You may, merclore, market the device, solo, connual registration, listing of general controls provisions of the rict mercials comments of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (300 above) into 5. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulation i It may be subject to such adultional controllar Enting Cargo, Co. 9
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thie 21, Coub of I caeral suggest in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a backers.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmation the Journer Federal agencies. You must or any Federal statutes and regulations as annuding, but not limited to: registration and listing (21 comply with an the Ave 3 requirements 801 and 809); and good manufacturing practice and CI'K I all 807), laoching (21 CF ruality 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) I ms letter will anow you to begin manteang your and equivalence of your device to a legally premained notification. "The I D'A manig of ousleasification 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Pill o Diagnostic Dovies Brance to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outlif one getierers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, 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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Indications for Use
510(k) Number (if known): K043245
Easy Pain Supreme Self-Monitoring Blood Glucose System Device Name:
Indications For Use:
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by The Easy Pain Supreme Scir Monitonia Breakurement of glucose levels
individuals with diabetes. It is for the quantitative the offectiveness of diabete individuals with diabetes. It is for the quantitiation the effectiveness of diabetes
in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes in froom oupliary on the home and in clinical settings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albeto Caz
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K043245
Page 1 of 1
§ 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.