(85 days)
The ACURA PLUS 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 ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The ACURA PLUS Multi Blood Glucose Monitoring System (BGMS) consists of an ACURA PLUS Multi Blood Glucose Meter, ACURA PLUS Multi Blood Glucose Test Strips, and ACURA PLUS Control Solutions with three different glucose concentrations ("Control 1", "Control 2", and "Control 3" ranges). The ACURA PLUS 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. ACURA PLUS Control Solutions are used to test the performance of the system with a known range of glucose.
The provided text is a 510(k) summary for the ACURA PLUS Multi Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information about acceptance criteria, specific performance data from a study, sample size, data provenance, expert qualifications, adjudication methods, or specific details for training sets that you requested.
The document states: "Based on the submitted information in this premarket notification, the candidate device is substantially equivalent to the predicate device. Further, the candidate device has met the performance, safety, and effectiveness of the device for its intended use." This is a general statement of compliance, not a detailed report of a study meeting specific quantitative acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the document, with the caveat that detailed performance results and acceptance criteria are not provided:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states a general conclusion that the device "met the performance, safety, and effectiveness of the device for its intended use" and is substantially equivalent to the predicate device, but does not list specific numerical acceptance criteria or corresponding device performance values.
2. Sample size used for the test set and the data provenance
This information is not provided for the blood glucose measurement performance. The only sample size mentioned relates to the disinfection study: "10,950 each of pre-cleaning and disinfection cycles for meter". Data provenance for this disinfection study is not explicitly stated beyond being performed "by an outside commercial testing service".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The device measures glucose levels, which often uses a laboratory reference method as ground truth, not expert human assessment in the way an imaging device might.
4. Adjudication method for the test set
This information is not provided. As above, for a quantitative measurement device like a blood glucose meter, the ground truth is typically a direct measurement from a reference method, rather than an adjudicated expert consensus.
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
An MRMC study is not applicable and not mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a quantitative blood glucose monitoring system. Its "standalone" performance would be its accuracy in measuring glucose. While the document mentions the electrochemical biosensor technology, it does not provide details of accuracy studies with specific acceptance criteria and performance results.
7. The type of ground truth used
For blood glucose measurement systems, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). This is implied by the nature of the device but not explicitly stated in the provided text.
8. The sample size for the training set
This information is not applicable as the device is not described as an AI/ML device that requires training data in the conventional sense. It's an electrochemical biosensor.
9. How the ground truth for the training set was established
This information is not applicable as the device is not described as an AI/ML device that requires training data.
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K13/4/9
Image /page/0/Picture/1 description: The image shows the logo for i-sens. The logo consists of the lowercase letters 'i-sens' in a bold, sans-serif font. A stylized circle with two curved lines above it partially encloses the 'i' in 'i-sens'. The logo is simple and modern.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Inc.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
510(k) Summary
(As required by 21 CFR 807.92)
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Type of 510(k) | Special 510(k) |
| SubmitterInformation | i-SENS, Inc.27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, KoreaTel.) +82-33-903-0767Fax) +82-33-748-6191e-mail: cylim@i-sens.comContact Person: Chae Yun Lim |
| Prepared Date | May 15, 2013AUG 09 2013 |
| Device NameandClassification | Trade name: ACURA PLUS Multi Blood Glucose Monitoring SystemCommon name: Blood Glucose Test SystemClassification product code: NBW, CGARegulation number: 21 CFR 862.1345 Glucose Test SystemClassification panel: 75, ChemistryDevice class: Class II |
| Predicate DeviceInformation | Device name: ACURA PLUS Blood Glucose Monitoring System510(k) number: K103278 |
| DeviceDescription | The ACURA PLUS Multi Blood Glucose Monitoring System (BGMS) consists ofan ACURA PLUS Multi Blood Glucose Meter, ACURA PLUS Multi BloodGlucose Test Strips, and ACURA PLUS Control Solutions with three differentglucose concentrations ("Control 1", "Control 2", and "Control 3" ranges).The ACURA PLUS Multi BGMS are based on an electrochemical biosensortechnology (electrochemical). The System measures the glucose level in wholeblood samples using a small electrical current generated in the test strips. ACURAPLUS Control Solutions are used to test the performance of the system with aknown range of glucose. |
| Intended Use: | The ACURA PLUS 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 ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA | |
| PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh | |
| capillary whole blood samples drawn from the fingertips and alternative sites. | |
| Comparison to | The candidate device and the predicate device consist of the same meter and test |
| the Predicate | strips. And the measurement principle, fundamental scientific technology, |
| Device | operating ranges, and performance characteristics of the candidate device are the |
| same as those of the predicate device. However, they have separate names because | |
| of the different indications for use (single- vs. multiple-patient use). Also, there | |
| are some label changes made in accordance with the changed indications for use. | |
| Both devices use same control solutions. | |
| 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 a |
| substrate in the blood sample. The meter converts electrical current to glucose | |
| concentration. | |
| Summary of | The device is intended for multiple patients use in a professional healthcare |
| Pre-cleaning | setting. Disinfection study was performed on the meter by an outside commercial |
| and Disinfection | testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL |
| Wipes (EPA Reg. No: 67619-12), in preventing the spread of blood-borne | |
| pathogens, using hepatitis B virus (HBV). The results demonstrated complete | |
| inactivation of live virus inoculated on the materials of the meter. | |
| We have also demonstrated that 10,950 each of pre-cleaning and disinfection | |
| cycles for 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 contains the logo for i-sens. The logo consists of the lowercase letters "i-sens" in a bold, sans-serif font. The "i" is dotted with a small circle, and the entire word is partially enclosed by a curved line that starts above the "i" and extends around the left side of the word.
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Image /page/2/Picture/0 description: The image shows a logo for i-sens. The logo features the text "i-sens" in a bold, sans-serif font. The "i" is lowercase, and there are three curved lines above it, resembling a stylized eye or sensor. The overall design is simple and modern.
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i-SENS, Inc. 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
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1999 - 1999
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2013
i-SENS, Inc. C/O Chae Yun Lim 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Re: K131419
Trade/Device Name: ACURA PLUS Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: July 10, 2013 Received: July 11, 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). and Cosmetic rearly market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mannes of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adviteration. 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), if your device is elassinos controls. Existing major regulations affecting your device can be it may be sucjoet to additions, 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 than Federal statutes and regulations administered by other Federal agencies. You must or any i vothat salates and encluding, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
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Page 2-Chae Yun Lim
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/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): _k131419
Device Name: ACURA PLUS Multi Blood Glucose Monitoring System
Indications for Use:
The ACURA PLUS 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 ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(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)
Katherine Serrano -S
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131419
Page 1 of 1
X
§ 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.