(95 days)
The GlucoManager Data Management Software (GDMS) is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. The device is not intended to provide any diagnosis based upon patient results.
The GlucoManager Data Management Software enable users the ability to export data from the EasyMax N (KU63099) gidcose meter on computer via a RS232 Cable. The GlucoManager Data Managenient Gonward to include users in review, analysis and evaluation of historical blood glucose test results any diegencis based unon patient results.
Here's a breakdown of the acceptance criteria and study information for the GlucoManager Data Management Software based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Function Tested | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Design and Ease-of-Use | Not explicitly stated (implied user satisfaction) | Subjects demonstrated ability by usage and evaluation tests; high rating of features/functions; understanding of software and instructions. |
| Features/Functions (19 specific tests) | Not explicitly stated (implied successful operation) | Performance recorded and evaluated by study administrators (Observers), indicating successful operation. |
| User Instructions Accuracy and Followability | User instructions are accurate and easy to follow | Validated by participant feedback and observer evaluation. |
| Participant Ratings with Respect to Features/Functions | Not explicitly stated (implied satisfactory ratings) | Evaluated through a separate questionnaire, contributing to overall positive conclusion. |
| Discrepancies (Bugs/Error Messages) | No significant discrepancies found (implied) | No discrepancies (bugs/error messages) were reported as found during the evaluation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 106 subjects
- Data Provenance: Not explicitly stated, but the submission is from "EPS Bio Technology Corp., Hsinchu City, Taiwan, R.O.C." and the overall submission is to the FDA for a 510(k), suggesting either data collected in Taiwan for the US market or a multinational study. The study is prospective as it's a "User acceptance Study" conducted to evaluate the software.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The term "ground truth" for this type of software (data management) is primarily related to its functionality and user experience, not a clinical outcome or diagnostic accuracy.
- Number of Experts: Not explicitly stated as "experts" for ground truth, but "EPS study administrators (Observers)" who were "familiar with proper use of GlucoManager Data Management Software" evaluated the performance of each user. It implies at least one, likely several, administrators.
- Qualifications of Experts: "Familiar with proper use of GlucoManager Data Management Software." No specific professional qualifications like "radiologist with 10 years of experience" are mentioned as this is a usability/functional study, not a clinical diagnostic one.
4. Adjudication Method for the Test Set
- Not explicitly stated. The study involved "observers" evaluating participant performance and participant self-reporting through questionnaires. It appears to be a direct observation and survey method rather than a multi-reader adjudication process typically seen in image analysis or diagnostic studies.
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
- No, an MRMC comparative effectiveness study was not done. This device is a data management software for glucose meters, not an AI-powered diagnostic tool. The study focused on user acceptance and functionality.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not done. The primary study was a "User acceptance Study" which inherently involves human interaction ("human-in-the-loop"). The software's function is to facilitate human review and analysis, not to operate autonomously in a diagnostic capacity.
7. The Type of Ground Truth Used
- The "ground truth" for this user acceptance study was based on:
- Direct observation and evaluation of user performance by EPS study administrators.
- Participant self-reported feedback through questionnaires on features/functions, understanding of the software, and comprehension of instructions.
- Absence of reported discrepancies (bugs/error messages).
- This is primarily a functional and usability "ground truth" rather than a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
- Not applicable / not mentioned. This type of software (data management) typically does not involve a "training set" in the machine learning sense. The software is developed based on requirements and then tested for functionality and usability.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the context of this software development and evaluation, there's no ground truth established for it. The software's design and functionality are likely based on standard software engineering practices and the requirements for managing blood glucose data.
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Traditional 510(k) SUMMARY
This Summary of 510(K) safety and effectiveness information is being submitted in
telling of 510(K) safety and effectiven and effective and This Sunimary "Or "OTO(N) - Sales)" - Sales - "SMDA and 21CFR §807.92
JUL 31 2009
A. 510(K) number is :
B. Purpose for Submission:
Purpose for Submission:
New submission for an accessory Data Management Software application for glucose meters
C. Submitter information
| Company: | EPS Bio Technology Corp. |
|---|---|
| Address: | 2F, No. 49-2, Lane 2, Guang Fu Rd., Sec.2 Hsinchu City, Taiwan, |
| R.O.C. | |
| Contact Name: | Mr. Y.C. Lei, General Manager |
| Phone: | 886-3-5752522 |
| Fax: | 886-3-5752552 |
D. Proprietary and Established Names:
GlucoManager Data Management Software
D. Type of Test:
Type of Test:
GlucoManager Data Management Software is a software medical device which serves as GlucoManager Data Management Solware is a bonwere the software in personal glucose
RS232 cable based accessory which interfaces between the software RS232 cable based accessory whiten international wanagement Software.
E. System Descriptions:
- Device Description:
Device Description:
The GlucoManager Data Management Software enable users the ability to export data. The GlucoManager Data Managenient Gonward on computer via a RS232 Cable. The from the EasyMax N (KU63099) gidcose include users in review, analysis and GlucoManager Data Managenient oonward to support effective diabetes
evaluation of historical blood glucose test results any diegencis based unon patient evaluation of historical biood glucose test rocally to samp
management. The device is not intended to provide any diagnosis based upon patient results.
2. Principles of Operation:
Principles of Operation.
The GlucoManager Data Management Software has an interface accessory to compatible meters: EasyMax N (K083099) meter.
- Modes of Operation:
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The GlucoManager Data Management Software is compatible with Microsoft® Windows®
The Club States Coop Mindows 98 Windows 98 Windows Me operating systems The GlucoManager Data Management Sonware is compatible with
Vesta, XP, Windows 2000, Windows 98,Windows Me operating systems
Hardware specifications:
Hardware specifications:
• Intel(or Compatible) Pentium II 300 MHz processor or higher
- farences Compatible) Pentium II 300 MHz processor of tights and on and the mail on and the mail on and the manage (RAM)
32 Megabytes (MB) or greater of available random acc - 32 Megabyteo (111-)
20 MB of free hard disk space minimum - . Compact disk (CD) drive
- · Mouse
- . Mouse
- . EPS RS232 Download Cable
- F. Common or Usual Name: Common of Usual Namo:
GlucoManager Data Management Software
G. Regulatory Information:
-
- Regulation section: Regulation section:
21 CFR 862.1345, Glucose Test System Regulation of Calculator/data processing module for clinical use.
21CFR Sec.-862.2100 - Calculator/data processing module for clinical use.
21CFR Sec.-862.2100 - Calculator/d
- Regulation section: Regulation section:
-
- Classification: Class II and 1 respectively
-
- Product code: Product code:
NBW, System Test, Blood Glucose, Over the Counter
NBW, System Test, Brosseing Module, For Clinical NBW, System Test, Blood Glucose, Over the Sec.
JQP, Calculator/Data Processing Module, For Clinical Use
- Product code: Product code:
-
- Panel: Chemistry 75
- H. Intended Use:
- Intended use(s): see Indications for Use below
2. Indication(s) for use:
incatorion be interest Data Management Software (GDMS) is intended for use in The GlucoManager Data Management Software (GDMS) Is meeting on their care care care care care care care care care care home and clinical settings to aid people with blabeles and evaluation belows to
professionals in the review, analysis and evaluation blood glucose test results any home and other and evaluation blood group is not intended to provide any
support effective in the review, analysis not intended to provide any
support effective in and consti support enective upon patient results.
-
- Special conditions for use statement(s): Special conditions for use staten (K083099) meter
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-
- Special instrument requiréments: Not Applicable
- Substantial Equivalence Information:
Substantial Equivalence name(s): ﻨﺖ Substantial Equice name(s): Predicate device namelsi:
In Touch Diabetes Management Software- 2. Device Company Lifescan
-
- Predicate 510(k) number(s): K984527
- 4 Comparison with predicate:
4.1 Similarities
| 4.1 Similarities | EPS GlucoManager | |
|---|---|---|
| Element ofComparison | LifeScan IN TOUCH®Diabetes ManagementSoftware (K984527) | Data ManagementSoftware (GDMS) |
| About User | ||
| - Intended Use (S) | IN TOUCH® DiabetesManagement Software can helphealthcare professionals andpeople with diabetes monitor bloodglucose levels. You and yourhealthcare professional can use INTOUCH Software to plan meals,exercise, lifestyle, and medicationto help control diabetes. INTOUCH Diabetes ManagementSoftware lets you track and reviewblood glucose test results. Thishelps you keep your blood glucoselevels stable. | The GlucoManager DataManagement Software (GDMS) isintended for use in home andclinical settings to aid people withdiabetes and their health careprofessionals in the review,analysis and evaluation bloodglucose test results to supporteffective diabetes management.The device is not intended toprovide any diagnosis based uponpatient results. |
| - Single User Use | Single and Multi-Patient | Single Patient |
| About Installation | ||
| - Computer SystemRequirement | * A supported blood glucosemeter,* CD-Rom drive* 100~200 MB minimum of freehard disk space while installation,100 MB after installation | * EasyMax N Blood GlucoseMeter,* Compact Disk (CD) drive* 20 MB or greater of free harddisk space,* 32 MB or greater of free RAM, |
| * Video monitor and adapter withat least 800 x 600 pixels and 256colors,* Available 9-pin or 25-pin COM orUSB port.* Operating system of Microsoft®Windows® 98, Windows® 2000Professional, Windows® XPHome and Professional | * 800 x 600 (or higher) resolutionmonitor,* Available 9-pin RS232 serial port.* Operating system of Microsoft®Windows® Me, Windows 98,Windows® 2000, Windows® XP,Windows® Vista | |
| - Installation of Program | Installed using CD | Installed using CD |
| - Language Capabilities | English, Spanish | English |
| - Ability to UninstallProgram | Yes | Yes |
| - Ability to Link toDifferent DatabaseVersions | Yes | Yes |
| - Technical Support | Yes | Yes, Customer Service CenterToll-Free Number: 1-866-203-276 |
| About Transmission | ||
| - Auto-detect COM Port | Yes | Yes |
| - Cable Availability | Serial Cable, Cable availableseparately. | Serial Cable, Cable availableseparately. |
| - Capable of UploadingData from VariousDevices | Software driver must be uploadedon the device or installed on PC. | Software driver must be uploadeon the device or installed on PC. |
| About Operation | ||
| - Ability to AccessProgram via Icon orExplorer | Yes | Yes |
| - Viewing the User'sManual | Yes, link provided via icon | Yes |
| - Copy Database toSeparate File | Yes | Yes |
| - Copy Saved DatabaseBack to AchieveDatabase | Yes | Yes |
| About Personal Settings | ||
| - Unit of Blood Glucose | Choice of mg/dL or mmol/L | Pre-Set to mg/dL |
| About Report | ||
| - Report Types | Logbook, Line Graph, Average | Log Book, Glucose Trend,Average Day, Average Week |
| - Downloaded ResultsCannot Be Edited orDeleted | Yes | Yes |
| - Ability to Modify MeterAverage Results | No | No |
| About Patient and Therapy Management | ||
| - Required Informationon Use (Patient) Enter | No required information | No use (patient) enter |
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.
| 4. 2 DifferencesElement ofComparison | LifeScan IN TOUCH®Diabetes ManagementSoftware (K984527) | EPS GlucoManagerData ManagementSoftware (GDMS) |
|---|---|---|
| About Operation | ||
| - Ability to Clear MeterResults in Memoryand Set Mater Clockto a Specific Date andTime | Yes | No |
| - Ability to Email Reportfrom PC Directly fromProgram | Yes | No |
| About Personal Settings | ||
| - Ability to Display 12 or24 Hour Clock Formatand Change DateFormat | Yes, mm/dd/yy or dd/mm/yy. | No |
| - Ability to SynchronizeMeter Clock to PCUpon Download | Yes | No |
| - Ability to PersonalizeTarget Ranges | Yes | No |
| - Ability to Set DefaultTarget Range | Yes | No |
| - Ability to EnterHypoglycemic Range | Yes | No |
| - Ability to Enter InsulinRegiment | Yes | No |
| - Ability to Set DefaultFavorite Report | Yes | No |
| - Ability to Default to | Yes | No |
| Manufacturer Settings | ||
| About Report- Report Types | Data List, Data Statistics, WithinTarget, Standard Day, HistogramChart, 14 Days Summary, Glucose& Insulin | No |
| About Modifying Results | ||
| - Manual Entry | Yes | No |
| - Ability to Input- Additional Information | Yes, insulin doses, carb data,exercise data, health notes,comments. | No |
| - Ability to SpecifyComplicationsAssociated withDiabetes by Patient | Yes | No |
| - Specifying / EnteringMedications / Insulin | Yes, up to three differentmedicines, insulin types | No |
| - Deleting Results,Patients and AllAccompanyingRecords | Yes, only manual entry results maybe deleted. | No |
| About Patient and Therapy Management | ||
| - Search PatientCapability | Yes | No |
| - Diabetes Control | Yes, including insulin list, exercise,carbohydrate | No |
| - Doctor Informationand DiabetesEducator Information | Yes, one doctor may be entered.one diabetes educator may beentered. | No |
| - Ability to Limit ResultSelection by LastTransfer | Yes, with the exception of the InTOUCH Ultra. | No |
Г
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- J. Standard/Guidance Document Referenced (if applicable):
Standard/Guidance Document Referenced (if 3pplicable): ndard/Guidance Document Referenced (if applicable).
IEC 62304:2006 Medical device software – Software life cycle process
IEC 62304:2007 - Modical Devices – Application ndard/Guidance Document (1000)- 1.
-
- Devices
K. Test Principle:
Not Applicable
L. Performance Characteristics (if/when applicable):
{
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1. Analytical performance:
- a. Precision/Reproducibility:
- Precision/Reproducibility.
See compatible meters EasyMax N SMBG system (K083099)
See compatible meters EasyMax N SMBG system (K083099) b. Linearity/assay reportable range: - Linearity/assay reportable range.
See compatible meters EasyMax N SMBG system (K083099) - l raceablility, Stablilly, Expected Values (SS system (K083099)
See compatible meters EasyMax N SMBG system (K083099) - d. Detection limit: Detection limit.
See compatible meters EasyMax N SMBG system (K083099) e. Analytical specificity: - Analytical specificity.
See compatible meters EasyMax N SMBG system (K083099) f. Assay cut-off:
ssay cut-off:
See compatible meters EasyMax N SMBG system (K083099)
-
- Comparison studies:
-
- Clinical studies:
- a. Clinical Sensitivity: Clinical Sensitivity.
See compatible meters EasyMax N SMBG system (K083099) - b. Clinical specificity:
- See compatible meters EasyMax N SMBG system (K083099)
- See compatible meters Lasylwan Noman b, are not applicable):
c. Other clinical supportive data (when a. and b, are not applicable); Other clinical supportive data (when a . and d, are not approad.org
A User acceptance Study using 106 subjects was conducted to evaluated to evaluated to evalua A User acceptance Study using 100 Subjocos Ranalisote Ranal Software-
- To evaluate design and ease-of-use
-
- To evaluate design and East on the features / functions
- To document participant feedback on the features porformance
-
- To document participant lecuback on participant performance
- To document Observer feedback on participant performance
-
- To document Observer recubations are accurate and easy to follow
- To validate the user instructions are accurate and easy to follow
-
- To validate the user instructions with respect to features / functions
- To evaluate participant ratings with respect to features / found during the
-
- To evaluate participant ratings with respect to leatures Pranation
- To report any discrepancies (bugs/error messages) found during the evaluation
- To report any dis
-
The subjects (Users), were required to have a minimum of basic computer skills and feel
s of the subjects and any devel Organized Organisan Sustem The subjects (Osers), word required Operating System.
Conclusions were based on the subjects' ability to demonstrate by usage and evaluation tests), their Conclusions were based on the subjects as responses to 19 feature/function tests), their (rating) of features/functions of the software, their understanding of how to use the
understanding of the applications of the software, their understanding of the user understanding of the applications of the sontations for undorstanding of the suser
software, their comprehension of the instignations for use, as well as user software, their comprehension of the senarate questionnaire.
{7}------------------------------------------------
Performance of each User was recorded and evaluated by EPS study administrators
Performance of each User was recorded and evaluated by EPS Study Lannines
(Observers), who are familiar with proper use of GlucoManager Data Management Sof Performance of outh
-
- Clinical cut-off: Clinical cut-on:
See above associated devices
- Clinical cut-off: Clinical cut-on:
-
- Expected values/Reference range: Expected ValuesAllers
See above associated devices
- Expected values/Reference range: Expected ValuesAllers
- Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
The labeling is sufficient and it satisfies the requirements of 21 CFR M. Proposed Labeling: - Conclusion:
The submitted information in this premarket notification is complete and supports a
nd internation on ivalones decision, N. Conclusion: The submitted informed decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
EPS Bio Technology Corp. c/o Y.C. Lei 2 F, No.49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City China (Taiwan) 300
'JUL 8 1 2009
Re: K091229
Trade/Device Name: Glucomanager Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: April 23, 2009 Received: May 05, 2009
Dear: Y.C. Lei:
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 either class II (Special Controls) or class III (PMA), 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).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation 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 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 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 CDR1'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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting 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):
Device Name: GlucoManager Data Management Software
Indications for Use:
The GlucoManager Data Management Software (GDMS) is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. The device is not intended to provide any diagnosis based upon patient results.
Prescription Use
AND/OR
V Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sian-
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K091229
§ 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.