(357 days)
The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS 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 blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The ACURA PLUS 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 ACURA PLUS 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: ACURA PLUS Meter (Model GM505RA), ACURA PLUS Test Strips, ACURA PLUS Control Solutions for three different glucose concentration ranges (called "Low", "Normal" and "High" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
The provided text highlights a 510(k) summary for the ACURA PLUS Blood Glucose Monitoring System. However, it does not contain detailed information about specific acceptance criteria for device performance, nor does it present a study that quantifies the device's performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through superficial changes (casing design, software modification for displaying averages) and stating that a "validation study was conducted" confirming these modified features operated properly.
Therefore, many of the requested details cannot be extracted from this document.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission states "The test results confirmed that the modified features operated properly. Thus, ACURA PLUS BGMS demonstrated satisfactory performance and is suitable for its intended use." but does not give specific numerical acceptance criteria or the device's performance results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 provided in the document. Blood glucose monitoring systems typically use laboratory reference methods (like hexokinase method) to establish ground truth, not expert consensus in the way a medical imaging device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system (meter and test strips). The statement "The test results confirmed that the modified features operated properly" implies performance testing was done on the device's functionality. However, specific standalone performance metrics (e.g., accuracy, precision) against a defined standard are not explicitly provided in terms of numerical results or how many samples were tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated for this particular submission, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI analyzer which uses a glucose oxidase or hexokinase method) for glucose measurement. The document states a "validation study was conducted" but doesn't specify the ground truth method used.
8. The sample size for the training set
This information is not provided in the document. Given the nature of a blood glucose monitor, it's unlikely to have a "training set" in the machine learning sense. Performance validation would involve testing against known glucose concentrations or patient samples, but this is testing, not training.
9. How the ground truth for the training set was established
As above, a "training set" in the machine learning sense is not applicable to this device.
Summary of available information:
The 510(k) submission for the ACURA PLUS Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to its predicate devices (CareSens N Blood Glucose Monitoring System and ACURA Blood Glucose Monitoring System). The modifications were described as:
- Meter outer casing design change.
- Software modification for displaying averages stored in the meter's memory.
The document states: "To verify whether the modified feature operates correctly, the validation study was conducted. The test results confirmed that the modified features operated properly. Thus, ACURA PLUS BGMS demonstrated satisfactory performance and is suitable for its intended use." This indicates a study was performed to validate the changes, but no specific acceptance criteria or performance data from that study are included in this summary document. The submission concludes that the "modifications of ACURA PLUS BGMS do not affect the safety and effectiveness of the device and the intended use."
{0}------------------------------------------------
K103278
OCT 2 8 2011
Image /page/0/Picture/1 description: The image shows a logo with the text "i-sens" in a stylized font. The "i" is enclosed in a circle, and there is a small dot above the "i". The text is in black and appears to be a company or brand logo. The logo is simple and modern.
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
510(k) Summary
(As required by 21 CFR 807.87)
| Introduction: | According to the requirements of 21 CFR.807.92, the following informationprovides data needed to understand the basis for determining substantialequivalence. | ||||
|---|---|---|---|---|---|
| 510(k) Number is: | K103278 | ||||
| Type of 510(k): | Special 510(k) | ||||
| 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 OhTel.) +82-33-903-0760Fax) +82-33-748-6191 | ||||
| Device Name: | Trade name:ACURA PLUS Blood Glucose Monitoring SystemCommon Name:Glucose Test System | ||||
| Device | * ACURA PLUS Blood Glucose Meter and Test Strips | ||||
| Classification: | 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 |
{1}------------------------------------------------
* ACURA PLUS Control Solution
| Product Code | Classification | RegulationSection | Panel |
|---|---|---|---|
| JJX - Quality control material | Class I | 21 CFR862.1660 | 75,Chemistry |
Type of Test: Quantitative, Amperometric method Enzyme: Glucose oxidase (Aspergillus sp.)
- System Description: The ACURA PLUS 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: ACURA PLUS Meter (Model GM505RA), ACURA PLUS Test Strips, ACURA PLUS Control Solutions for three different glucose concentration ranges (called "Low", "Normal" and "High" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
- Intended Use: The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS 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 blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The ACURA PLUS 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.
{2}------------------------------------------------
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
| Predicate Device: | |
|---|---|
| 1) Device name: | CareSens N Blood Glucose Monitoring System |
| 510(k) Number: | K083468 |
| 2) Device name: | ACURA Blood Glucose Monitoring System |
| 510(k) Number: | K083468/A001 |
Comparison with
Predicate Device:
The modified ACURA PLUS BGMS has the following similarities to the predicate devices:
-
same intended use,
-
same operating principle,
-
same fundamental scientific technology,
-
same product specifications,
-
same operating ranges,
-
manufactured by the same process.
The modifications from the predicate devices are as follows:
-
Meter outer casing design change,
-
Software modification of displaying averages stored in the meter's memory.
| Technological Characteristics: | The ACURA PLUS BGMS has the same fundamental scientific technology as the predicate devices (CareSens N BGMS, ACURA BGMS). |
|---|---|
| Assessment of Performance: | To verify whether the modified feature operates correctly, the validation study was conducted. The test results confirmed that the modified features operated properly. Thus, ACURA PLUS BGMS demonstrated satisfactory performance and is suitable for its intended use. |
| Conclusion: | The modifications of ACURA PLUS 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 ACURA PLUS BGMS is substantially equivalent to the predicate devices. |
.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ISENS Attn: Hyun Joon Oh 465-6 Wolgye-dong, Nowon-gu Seoul 139-845 Republic of Korea
OCT 2 8 2011
Re: k 103278
Trade/Device Name: ACURA PLUS Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class 11 Product Code: CGA, NBW, JJX Dated: October 13, 2011 Received: October 17, 2011
Dear Dr. Oh:
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.
{4}------------------------------------------------
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please nate the regulation enlitled, "Misbranding by reference to premarket notification" (2) CFR Part 800 97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the responsible 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) 638-204) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/ndustr/ddf 2017/12/2
Sincerely yours.
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K103278
Device Name: ACURA_PLUS Blood Glucose Monitoring System
Indications for Use:
The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS 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 blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The ACURA PLUS 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 _____________________________________________________________________________________________________________________________________________________________ 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 Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103278
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.