(50 days)
The SmartLog Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is intended for use in the home and professional settings to belp people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for an effective diabetes management program. The Smarti of Diabetes Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
The SmartLog Diabetes Management Software is an optional data management software for use only with the i-SENS brand of Blood Glucose Meters ("i-SENS Blood Glucose Meters") except CareSens POP and CareSens N Mini. The SmartLog Diabetes Management Software allows the transfer of data from the i-SENS Blood Glucose Meters to a personal computer for enhanced data management using graphic displays and analysis tools of the device. Various graphic analysis tools in this software help users of i-SENS BGM system easily analyze the trends and changes in their blood glucose.
Here's an analysis of the acceptance criteria and study information for the SmartLog Diabetes Management Software, based on the provided text:
Device Name: SmartLog Diabetes Management Software
510(k) Number: K13346
1. Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative acceptance criteria for device performance. The "acceptance criteria" for this type of submission are implicitly that the new device performs at least as well as the predicate device across the functions it shares and that new features do not introduce safety or effectiveness concerns.
The study described is largely focused on software validation and data accuracy transmission. Here's a table summarizing the reported "performance" in the context of the validation activities mentioned:
| Acceptance Criteria Focus (Implicit) | Reported Device Performance |
|---|---|
| Data Accuracy Transmission | Demonstrated data accuracy transmission for each meter. (Specific metrics like percentage error, difference from source data, or number of errors are not provided in this summary, but the general statement indicates successful transmission.) |
| Software Functionality/Usability | Validation activities covered a broad range of software functions: - Setup Test - End Test Download Reading Test - Data Management Test - User Profile Test - Manual Entry Test - Print Test - Email Test - Consumer Study - Human Factors Study (The summary concludes substantial equivalence, implying these tests were passed successfully and the software performs as intended for its stated use. Specific pass/fail criteria or quantitative results for these individual tests are not detailed in this summary.) |
| Substantial Equivalence to Predicate | The candidate device (SmartLog Diabetes Management Software) was found to be substantially equivalent to the predicate device (PC care Blood Glucose Data Management Software, K100937). This is the overarching acceptance criterion for a 510(k) submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set." It broadly refers to "each meter" when discussing data accuracy transmission.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the validation studies. The submitter is based in Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the software validation tests. The "ground truth" for data transmission accuracy would likely be the data stored directly on the i-SENS blood glucose meters themselves, which the software is designed to download.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none). Given the nature of the software (data management and display) and the validation activities (software functionality and data transmission), adjudication by multiple experts is not typically applicable in the same way it would be for diagnostic AI algorithms analyzing medical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The SmartLog Diabetes Management Software is a data management tool, not a diagnostic interpretation AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The software itself is standalone in the sense that it operates as an algorithm on a PC/Mac to manage and display data from blood glucose meters. The "validation activities" listed (Setup Test, Download Reading Test, Data Management Test, etc.) inherently represent tests of its standalone functionality, albeit without specific performance metrics (like sensitivity/specificity for a diagnostic AI). The "Consumer Study" and "Human Factors Study" do involve human interaction, but the core function of data processing is algorithmic. However, this is not an "algorithm-only" performance study in the typical sense used for complex diagnostic algorithms.
7. The Type of Ground Truth Used
The implicit "ground truth" for the data accuracy transmission tests would be the raw data exactly as stored on the i-SENS blood glucose meters. For the functional tests (e.g., "Print Test," "Email Test"), the ground truth would be the expected successful completion of the action and the correct output.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This device is a data management software, not a machine learning model that requires a training set. Its functionality is based on programming logic to import, organize, and display existing glucose data, rather than learning patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no description of how its ground truth was established.
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K 13346
i-SENS, Inc. 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
DEC 19 2013
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.) +82-33-903-0762Fax) +82-33-748-6191e-mail: hykang@i-sens.comContact Person: Hye Young Kang |
| Prepared Date | November 20, 2013 |
| Device NameandClassification | Trade name: SmartLog Diabetes Management SoftwareCommon name: Diabetes data management systemClassification product code: NBW, JQPRegulation number: 21 CFR 862.1345 Glucose Test System21 CFR 862.2100, calculator/data processing moduleClassification panel: 75, ChemistryDevice class: Class II / Class I, reserved |
| Type of Test | The SmartLog Diabetes Management Software is a software medical device thatinterfaces with the i-SENS blood glucose monitoring systems using the specialUSB cable. |
| SystemDescription | 1) Device DescriptionThe SmartLog Diabetes Management Software is an optional data managementsoftware for use only with the i-SENS brand of Blood Glucose Meters ("i-SENSBlood Glucose Meters") except CareSens POP and CareSens N Mini. TheSmartLog Diabetes Management Software allows the transfer of data from the i-SENS Blood Glucose Meters to a personal computer for enhanced datamanagement using graphic displays and analysis tools of the device. Variousgraphic analysis tools in this software help users of i-SENS BGM system easily |
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| analyze the trends and changes in their blood glucose. | |
|---|---|
| 2) Optional principle | |
| The SmartLog Diabetes Management Software downloads all blood glucose test | |
| results along with their measurement dates and times from the i-SENS Blood | |
| Glucose Meters through the USB port connected to the PC with the special cable. | |
| The SmartLog Diabetes Management Software operates under a Microsoft | |
| Windows based OS or Apple Mac based OS and provides reports containing | |
| variety of graphs and statistics based on User-selectable data interval and blood | |
| glucose target ranges. | |
| 3) System Requirements | |
| · | CPU: 300 MHz Intel Pentium II or higher |
| · | RAM: 128 MB or higher |
| Minimum free hard disk space: 200 MB | |
| Windows® XP Home, Professional (SP2 or above), Windows® Vista (32-bit | |
| /64-bit), Windows® 7 (32-bit/64-bit) or Windows® 8 (32bit/64bit), | |
| MAC OS X 10.7.0 or later | |
| · | USB port |
| · | USB cable (Cable type: 2.5 mm jack cable or Mini-USB plug cable) |
| Mouse and Keyboard for data entry and menu selection | |
| Video monitor and adapter with at least 1024x768 pixel screen resolution and | |
| 256 colors | |
| Printer to print report | |
| Internet connection to send email | |
| Intended Use | The SmartLog Diabetes Management Software is PC-based software for use with |
| the i-SENS blood glucose meters. The SmartLog Diabetes Management Software | |
| is intended for use in the home and professional settings to help people with | |
| diabetes and their healthcare professionals in the review, analysis and evaluation | |
| of glucose test results for an effective diabetes management program. The | |
| SmartLog Diabetes Management Software allows the user to download Blood | |
| glucose readings automatically from the meter to the PC. | |
·
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Image /page/2/Picture/0 description: The image shows a logo with the text "i-sens" in bold, black font. A small, solid black circle is positioned above the "i" in "i-sens." The logo is partially encircled by a dashed line, creating a circular shape around the text and the dot above the "i."
| SubstantialEquivalenceInformation | 1) Predicate Device InformationDevice name: PC care Blood Glucose Data Management Software510(k) number: K100937 | |
|---|---|---|
| 2) Comparison to the Predicate Device | ||
| Item | PC care Blood Glucose DataManagement Software(Predicate Device) | SmartLog DiabetesManagement Software(Candidate Device) |
| Intended Use | The Diabetes Management Software isintended for use in the home andprofessional settings to help peoplewith diabetes and their healthcareprofessionals in the review, analysisand evaluation of glucose test resultsfor an effective diabetes managementprogram. The Diabetes ManagementSoftware allows the user to downloadBlood glucose readings automaticallyfrom the meter to the PC. | Same |
| Over-the Counter | Yes | Same |
| Accessory toGlucose meter | Yes | Same |
| Intended user | Home users, Healthcare Professional | Same |
| Use on | PC | PC / Mac |
| Setting Reminders | Yes | Same |
| Connectivity toMeter | USB cable | Same |
| Manual Data Entry | Yes | Same |
| Logbook | Yes | Same |
| Massaging | Yes | Same |
| Test Principle | Not Applicable |
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Image /page/3/Picture/0 description: The image shows a logo for i-sens. The logo features the lowercase letters 'i-sens' in a bold, sans-serif font. A dotted circle surrounds the letters, adding a visual element to the design. The logo is simple and modern.
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| ValidationActivities | We conducted software validation and bench testing to demonstrate data accuracy transmission for each meter. The following test reports are included in this submission.Setup Test, End Test Download Reading Test, Data Management Test User Profile Test, Manual Entry Test Print Test, Email Test Consumer Study, Human Factors Study |
|---|---|
| Conclusion | Based on the submitted information in this premarket notification, the candidate device is substantially equivalent to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's official name and national scope. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
December 19, 2013
I-SENS, INC. HYE YOUNG KANG 27-36 GWANGUN-RO, NOWON-GU SEOUL 139-845 KOREA
Re: K133346
Trade/Device Name: SmartLog Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: October 28, 2013 Received: October 30, 2013
Dear Mr. Kang:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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); 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.
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Page 2-Mr. Kang
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
:
K13346
Device Name SmartLog Diabetes Management Software
Indications for Use (Describe)
The Smartl of Diabetes Management Software is PC-based software for use with the i-SENS blood glucose meters. The SmartLog Diabetes Management Software is intended for use in the home and professional settings to belp people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for an effective diabetes management program. The Smarti of Diabetes Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
.. FOR FDA USE ONLY . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck
FORM FDA 3881 (9/13)
§ 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.