(95 days)
Not Found
No
The description focuses on data export, review, analysis, and evaluation of historical data, which are standard software functions, not indicative of AI/ML. There is no mention of AI, ML, or related concepts, and the performance study is a user acceptance study, not a study evaluating algorithmic performance.
No.
It explicitly states "The device is not intended to provide any diagnosis based upon patient results." and "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." which indicates it is a tool for managing existing conditions, not for therapy or diagnosis.
No
The "Intended Use / Indications for Use" section explicitly states: "The device is not intended to provide any diagnosis based upon patient results."
Yes
The device is described as "GlucoManager Data Management Software" and its function is to review, analyze, and evaluate blood glucose test results. While it interacts with a glucose meter via a cable, the device itself is the software component performing the data management and analysis, not the hardware meter or cable. The description focuses solely on the software's capabilities.
Based on the provided information, the GlucoManager Data Management Software (GDMS) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is for the "review, analysis and evaluation blood glucose test results to support effective diabetes management." It also clearly states, "The device is not intended to provide any diagnosis based upon patient results." IVD devices are typically used to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This software is for managing data from an IVD device (the glucose meter), not performing the diagnostic test itself.
- Device Description: The description reinforces that the software enables users to "export data from the EasyMax N (KU63099) gidcose meter" and "include users in review, analysis and evaluation of historical blood glucose test results." This is data management and analysis, not a diagnostic test.
- Lack of Diagnostic Function: The repeated emphasis that the device is not intended to provide diagnosis is a strong indicator that it is not an IVD.
The software acts as a tool to help users and healthcare professionals interpret data generated by an IVD device (the glucose meter), but it does not perform the diagnostic test itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
The GlucoManager Data Management Software enable users the ability to export data from the EasyMax N (KU63099) gidcose include users in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. The device is not intended to provide any diagnosis based upon patient results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A User acceptance Study using 106 subjects was conducted to evaluated to evaluate design and ease-of-use, to document participant feedback on the features / functions, to document Observer feedback on participant performance, to validate the user instructions are accurate and easy to follow, to evaluate participant ratings with respect to features / functions, to report any discrepancies (bugs/error messages) found during the evaluation. The subjects (Users), were required to have a minimum of basic computer skills and feel confortable in using Microsoft Windows Operating System. Conclusions were based on the subjects' ability to demonstrate by usage and evaluation tests), their (responses to 19 feature/function tests), their (rating) of features/functions of the software, their understanding of how to use the software, their comprehension of the instignations for use, as well as user feedback on the applications. Performance of each User was recorded and evaluated by EPS study administrators (Observers), who are familiar with proper use of GlucoManager Data Management Soft.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A User acceptance Study using 106 subjects was conducted to evaluated to evaluate design and ease-of-use, to document participant feedback on the features / functions, to document Observer feedback on participant performance, to validate the user instructions are accurate and easy to follow, to evaluate participant ratings with respect to features / functions, to report any discrepancies (bugs/error messages) found during the evaluation. The subjects (Users), were required to have a minimum of basic computer skills and feel confortable in using Microsoft Windows Operating System. Conclusions were based on the subjects' ability to demonstrate by usage and evaluation tests), their (responses to 19 feature/function tests), their (rating) of features/functions of the software, their understanding of how to use the software, their comprehension of the instignations for use, as well as user feedback on the applications. Performance of each User was recorded and evaluated by EPS study administrators (Observers), who are familiar with proper use of GlucoManager Data Management Soft.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
1
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
2
-
- 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 of | ||
| Comparison | LifeScan IN TOUCH® | |
| Diabetes Management | ||
| Software (K984527) | Data Management | |
| Software (GDMS) | ||
| About User | ||
| - Intended Use (S) | IN TOUCH® Diabetes | |
| Management Software can help | ||
| healthcare professionals and | ||
| people with diabetes monitor blood | ||
| glucose levels. You and your | ||
| healthcare professional can use IN | ||
| TOUCH Software to plan meals, | ||
| exercise, lifestyle, and medication | ||
| to help control diabetes. IN | ||
| TOUCH Diabetes Management | ||
| Software lets you track and review | ||
| blood glucose test results. This | ||
| helps you keep your blood glucose | ||
| levels stable. | 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. | ||
| - Single User Use | Single and Multi-Patient | Single Patient |
| About Installation | ||
| - Computer System | ||
| Requirement | * A supported blood glucose | |
| meter, |
- CD-Rom drive
- 100~200 MB minimum of free
hard disk space while installation,
100 MB after installation | * EasyMax N Blood Glucose
Meter, - Compact Disk (CD) drive
- 20 MB or greater of free hard
disk space, - 32 MB or greater of free RAM, |
| | * Video monitor and adapter with
at least 800 x 600 pixels and 256
colors, - Available 9-pin or 25-pin COM or
USB port. - Operating system of Microsoft®
Windows® 98, Windows® 2000
Professional, Windows® XP
Home and Professional | * 800 x 600 (or higher) resolution
monitor, - 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 Uninstall
Program | Yes | Yes |
| - Ability to Link to
Different Database
Versions | Yes | Yes |
| - Technical Support | Yes | Yes, Customer Service Center
Toll-Free Number: 1-866-203-276 |
| About Transmission | | |
| - Auto-detect COM Port | Yes | Yes |
| - Cable Availability | Serial Cable, Cable available
separately. | Serial Cable, Cable available
separately. |
| - Capable of Uploading
Data from Various
Devices | Software driver must be uploaded
on the device or installed on PC. | Software driver must be uploade
on the device or installed on PC. |
| About Operation | | |
| - Ability to Access
Program via Icon or
Explorer | Yes | Yes |
| - Viewing the User's
Manual | Yes, link provided via icon | Yes |
| - Copy Database to
Separate File | Yes | Yes |
| - Copy Saved Database
Back to Achieve
Database | 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 Results
Cannot Be Edited or
Deleted | Yes | Yes |
| - Ability to Modify Meter
Average Results | No | No |
| About Patient and Therapy Management | | |
| - Required Information
on Use (Patient) Enter | No required information | No use (patient) enter |
3
and the control control control control controllers and
.
.
:
,
.
4 i
.
・
: .
4
.
| 4. 2 Differences
Element of
Comparison | LifeScan IN TOUCH®
Diabetes Management
Software (K984527) | EPS GlucoManager
Data Management
Software (GDMS) |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| About Operation | | |
| - Ability to Clear Meter
Results in Memory
and Set Mater Clock
to a Specific Date and
Time | Yes | No |
| - Ability to Email Report
from PC Directly from
Program | Yes | No |
| About Personal Settings | | |
| - Ability to Display 12 or
24 Hour Clock Format
and Change Date
Format | Yes, mm/dd/yy or dd/mm/yy. | No |
| - Ability to Synchronize
Meter Clock to PC
Upon Download | Yes | No |
| - Ability to Personalize
Target Ranges | Yes | No |
| - Ability to Set Default
Target Range | Yes | No |
| - Ability to Enter
Hypoglycemic Range | Yes | No |
| - Ability to Enter Insulin
Regiment | Yes | No |
| - Ability to Set Default
Favorite Report | Yes | No |
| - Ability to Default to | Yes | No |
| | | |
| Manufacturer Settings | | |
| About Report
- Report Types | Data List, Data Statistics, Within
Target, Standard Day, Histogram
Chart, 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 Specify
Complications
Associated with
Diabetes by Patient | Yes | No |
| - Specifying / Entering
Medications / Insulin | Yes, up to three different
medicines, insulin types | No |
| - Deleting Results,
Patients and All
Accompanying
Records | Yes, only manual entry results may
be deleted. | No |
| About Patient and Therapy Management | | |
| - Search Patient
Capability | Yes | No |
| - Diabetes Control | Yes, including insulin list, exercise,
carbohydrate | No |
| - Doctor Information
and Diabetes
Educator Information | Yes, one doctor may be entered.
one diabetes educator may be
entered. | No |
| - Ability to Limit Result
Selection by Last
Transfer | Yes, with the exception of the In
TOUCH Ultra. | No |
Г
r
5
- 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):
{
6
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.
8
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).
9
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
10
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