(260 days)
Not Found
No
The description focuses on data management, visualization, and basic trend analysis, with no mention of AI, ML, or related concepts.
No
The device is described as "PC-based software 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." It manages and analyzes data from a blood glucose meter, but it does not directly treat or diagnose a medical condition.
No
The device is described as "data management software" that helps in the "review, analysis and evaluation of glucose test results" and provides "graphic displays and analysis tools." It does not directly perform a diagnosis but rather assists in managing and visualizing data collected from a blood glucose meter, which is used for diagnosis and monitoring.
Yes
The device is described as "PC-based software" and "optional data management software" that connects to a separate blood glucose meter via a USB cable. The software's function is to download, review, analyze, and display data from the meter, not to perform any physical or hardware-based function itself.
Based on the provided information, the PC care Blood Glucose Data Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: An IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening.
- Software's function: The PC care software's primary function is to manage and analyze data that has already been generated by an IVD (the i-SENS blood glucose meter). It does not perform any diagnostic testing on a specimen itself.
- Intended Use: The intended use clearly states it's for "review, analysis and evaluation of glucose test results," not for performing the test itself.
- Device Description: The description emphasizes data transfer and analysis tools, not the process of obtaining a diagnostic result from a sample.
While the software is used in conjunction with an IVD (the blood glucose meter), it is a data management tool and not an IVD itself.
N/A
Intended Use / Indications for Use
The PC care™ Blood Glucose Data Management Software is PC-based software 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 PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care™ Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
Product codes
NBW, JQP
Device Description
The PC care™ Blood Glucose Data Management Software is an optional data management software for use only with the i-SENS Blood Glucose Meters. The PC care™ Blood Glucose Data 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.
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 professional 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation activities are reported:
SV-05-Q. Software Validation Report (Question)
SV-05-A. Software Validation Report (Answer)
TR-EI-025-Starting Up Test
TR-E1-026-Printing Reports Test
TR-EI-027-Email Test
TR-EI-028- CareSens N Download Readings Test
TR-EI-029-Manual Entry Test
TR-EI-030-User Profile Test
TR-EI-031-Reports Test
TR-EI-060-Install Test
TR-EI-085-CareSens Communication Protocol
TR-EI-113-CareSens II Download Readings Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows a logo with the text 'i:sen' inside a circle. There are two curved lines above the 'i' in 'i:sen', possibly representing an eye or a stylized element. The text is in a simple, sans-serif font, and the overall design is minimalist.
i-SENS, Inc. 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)
DEC21 2010
- According to the requirements of 21 CFR.807.92, the following information A. Introduction: provides data needed to understand the basis for determining substantial equivalence.
- B. 510(k) Number is: K100937
- Type of 510(k): Traditional C.
- New submission for the Data Management Software which is an accessory D. Purpose for Submission: application for glucose meters.
- Submitted By: E. i-SENS, Inc. 465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel.) +82-2-916-6191 Fax) +82-2-942-2514 www.i-sens.com
- Dr. Hyun Joon Oh F. Contact Person: Tel.) +82-33-903-0760 Fax) +82-33-748-6191
- Device Name: Trade name: PC care™ Blood Glucose Data Management Software G. Common Name: Data Management Software Classification Name: Unclassified (accessory to a BGM system)
- PC care™ Blood Glucose Data Management Software is a software medical Type of Test: H. device that interfaces with the i-SENS blood glucose monitoring systems using the special USB cable (It is activated with the PC care™ program only).
1
I. System Description: 1) Device Description:
The PC care™ Blood Glucose Data Management Software is an optional data management software for use only with the i-SENS Blood Glucose Meters. The PC care™ Blood Glucose Data 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.
2) Operation principle:
The PC care™ Blood Glucose Data 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 PC care Blood Glucose Data Management Software operates under a Microsoft Windows Operating System 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 2 or equivalent
- · RAM: 128 MB or higher
- · Minimum free hard disk space: 60 MB
- · Windows 95, Windows 98, Windows ME, Windows 2000, Windows XP, Windows Vista (only 32bit), and Windows 7 (only 32bit).
- · USB port
- · PC care™ USB cable
- · Mouse / Keyboard
- · Video monitor and adapter with at least 1024x768 pixel screen resolution and 256 colors
- · CD-ROM drive
- · Printer (optional)
2
i-SENS. Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
- J. Regulation 1) Regulation section: Information: · 21 CFR Sec. 862.1345 - Glucose test system. · 21 CFR Sec. 862.2100 - Calculator/data processing module for clinical use. 2) Classification: Class II and I, respectively 3) Product code: · NBW - System, Test, Blood Glucose, Over The Counter · JQP - Calculator/Data Processing Module, For Clinical Use 4) Panel: 75, Chemistry
- The PC care™ Blood Glucose Data Management Software is PC-based K. Intended Use: software 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 PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care™ Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
- We believe substantial equivalence to the Zero-Click™ Data Management L. Substantial Equivalence System previously submitted by AgaMatrix, Inc. and subsequently cleared Information: by FDA.
- Predicate Device Name(s): Zero-Click™ Data Management System 2) Device Company: AgaMatrix, Inc. 3) Predicate 510(k) Number(s) : K062434
- M. Comparison with The glucose measurement test principle: same as Zero-Click™ Data Management System Predicate Device (K062434): Intended Use: same as Zero-Click™ Data Management System
3
ﺎ،
| 1) Similarities |
|---|
| ----------------- |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| About User | | |
| Intended Use | The PC care™ Blood Glucose Data
Management Software is PC-based
software 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
PC care™ Blood Glucose Data
Management Software connects to
an i-SENS blood glucose meter,
which comes with a PC care USB
cable. The PC care™ Blood Glucose
Data Management Software allows
the user to download Blood glucose
readings automatically from the
meter to the PC with or without
clicking a button. | The Zero-Click™ Data Management
System is intended for use in the
home and professional settings to aid
people with diabetes and their
healthcare professionals in the
review, analysis and evaluation of
glucose test results to support an
effective diabetes management
program. It is an optional data
management software accessory for
use with the AgaMatrix's Liberty™
Blood Glucose Monitoring System.
The Zero-Click™ Data Management
System allows users to download
Blood glucose reading automatically
from the meter to the PC without
clicking a button. |
| Software use indications | Single or Multiple user settings | Single or Multiple user settings |
| About Installation | | |
| Installation of Program | Installed Using CD | Installed Using CD |
| Ability to uninstall | Yes | Yes |
| Computer System
Requirements | CPU: Minimum 300MHz Intel
Pentium 2 or equivalent
RAM: 128 MB or higher | CPU: Minimum 700MHz, Intel
Pentium processor
RAM: Minimum 128 MB |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
| | Minimum free hard disk space: 60
MB | Hard drive space: 60 MB Minimum
(100 MB Recommended) |
| | Windows 95, Windows 98, Windo
ws ME, Windows 2000, Windows
XP, Windows Vista (only 32bit),
and Windows 7 (only 32bit). | Windows XP and Vista (32 bit) |
| | USB port | USB port |
| | PC care™ USB cable | Zero-Click™ Data Cable |
| | Mouse and keyboard | Mouse and keyboard |
| | Video monitor and adapter with at
least 1024x768 pixel screen
resolution and 256 colors | Monitor: Minimum 1024x768
resolution |
| | CD-ROM drive | CD-ROM drive |
| | Printer (optional) | Printer (optional) |
| Technical support | Yes | Yes |
| | About Transmission | |
| Capable of uploading
data from various
devices | Software driver must be installed on
PC | Software driver must be installed on
PC |
| Cable availability | USB cable | USB cable |
| Auto-detect COM port | Yes | Yes |
| About Operation | | |
| Ability to access DMS
program via icon or
explorer | Yes | Yes |
| Viewing the Owner's
Manual | Click the Help menu in the program
or personally open the manual file in
the installing CD. | Accessed via Help on toolbar or F1
on computer |
| Ability to clear meter
results in memory | No | No |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
| Indication for primary
test method | Not available | Not available |
| Ability to email report
from PC directly from
program | Yes | Yes |
| Time Block | Before/After Breakfast,
Before/After Lunch, Before/After
Dinner, Evening/Sleep Night | Before/After Breakfast,
Before/After Lunch, Before/After
Dinner, Night |
| About Personal Settings | | |
| Units of measure
automatically set by
country in setup
installation | No | No |
| Ability to personalize
target ranges | Yes | Yes |
| Ability to set default
target range by diabetes
type (Type I, Type II
Gestational, etc.) | No | No |
| Default glucose target
ranges available | Yes | Yes |
| Ability to enter
hypoglycemic range | Yes | Yes |
| Ability to set default
favorite report | Yes | Yes |
| Ability to enter insulin
regiment | No | No |
| Change meter audio
cues | No | No |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
| Ability to print report | Yes | Yes |
| Result type display | No | No |
| Ability to view results
and sort without
generating report | No | No |
| About Modifying Results | | |
| Downloaded results
cannot be edited or
deleted | Yes | Yes |
| Manual data Entry | allowed | allowed |
| Ability to input
additional information
on patient and
downloaded results | Yes - Health Profile, comment | Yes - Meal tag, Comments |
| Deleting Results | Only Manual entry results may be
deleted | Only Manual entry results may be
deleted |
| Ability to modify meter
average results | Yes, 14, 30, 60, 90 days or custom | Yes, Today, 7, 14, 30, 60, 90 days or
custom |
| Ability to view control
results | No | No |
| Ability to show
cholesterol results/select
units of measure | No | No |
| Ability to enter test site
for manual result entry | No | No |
| Ability to input
additional information
on manual result | Yes — comment | Yes - Meal tag, Comments |
| About Patient and Therapy Management | | |
| Required information | No | No |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
| on patient entry | | |
| Customizable schedule | Yes | Yes |
| Search patient
capability | No | No |
| Search for specific
patient in multiple
(clinic) user function | No | No |
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for i-SENS, Inc. The logo includes the company name in a stylized font. The address is listed as 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea. The telephone number is Tel. 82-2-916-6191.
·
5
Image /page/5/Picture/0 description: The image shows a logo with the text "i-sens" in a stylized font. The "i" is lowercase and has a circular design above it, resembling an eye or a target. The rest of the text, "-sens", is in lowercase and connected to the "i". The logo has a clean and modern appearance.
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for i-SENS, Inc. The address is 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea. The telephone number is 82-2-916-6191.
7
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea i-sens Tel. 82-2-916-6191
2) Differences
.
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| About Transmission | | |
| Function that monitors
the communication
status | Yes | No |
| About Operation | | |
| Ability to set meter
clock to a specific date
and time | No | Yes |
| Copy saved database
back to active DMS
database | No | Yes |
| Copy database to
separate file | No | Yes |
| About Personal Settings | | |
| Units of measure
display | Choice of mmol/L or mg/dL | Automatically selected based on unit
already set up in meter |
| Ability to change date
format | No | Yes (M-d-yy or d-M-yy) |
| Item | PC care™ Blood Glucose Data
Management Software (Device) | Zero-Click™ Data Management
System (Predicate Device) |
| Ability to synchronize
meter clock to PC upon
download | No | Yes |
| Ability to default to
manufacturer settings
(mealtime slots, target
glucose ranges, etc.) | No | Yes |
| Ability to display12 or
24 hour clock format | No | Yes |
| About Report | | |
| Report Types | Trend Graph, Average Analysis, .
Histogram, Target Analysis,
Logbook, Statistics, Period
Comparison Graph | Summary, Log Book, Target
Analysis, Glucose Trend, Histogram,
Average/Spread, Statistics |
| When printing Report,
check if select function
for the color/black and
white mode exists | Yes | No |
| About Modifying Results | | |
| Ability to specify
complications
associated with diabetes
by patient | Yes | No |
| Specifying/Entering
medications/insulin | Yes, up to 3 different insulin type | No |
| About Patient and Therapy Management | | |
| Diabetes control | Yes - Insulin list, Medication list,
Diet/Exercise options | No |
| Doctor information | Yes - One doctor name may be
entered | No |
| Item | PC careTM Blood Glucose Data
Management Software ( Device ) | Zero-ClickTM Data Management
System ( Predicate Device ) |
| Deleting Patients and all
accompanying records | No | Yes |
| Insurance information | Yes - One insurance number may be
entered | No |
| Hospital Information | Yes - One hospital name may be
entered | No |
| Diabetes Educator
information | Yes - One diabetes Counselor may
be entered | No |
| Ability to input
additional information
on patient | Yes - Date of diagnosis, Insulin
Initial Date/Dosage Method, Oral
Medication Initial Date, Diet,
Exercise, Working/Non-Working
day | No |
8
Image /page/8/Picture/0 description: The image shows a logo with the text "i-sens" in a bold, sans-serif font. To the left of the text, there is a circular graphic composed of three concentric circles. The innermost circle is solid, while the outer two are outlines. The logo appears to be for a company or product named "i-sens."
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
9
| N. | Modifications: | Among various functions, only simple and essential functions have been
selected and incorporated for user convenience. |
|----|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| O. | Standard/Guidance
Document
Referenced
(if applicable): | 1) FDA Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices
2) Labeling - Regulatory Requirements for Medical Devices
(FDA 89-4203)
3) ISO 15197: 2003 In vitro diagnostic test system |
Not Applicable P. Test Principle:
.
10
- Validation The test reports in this table are included in this submission, and can be Q. Activities: found under the Section Numbers below.
- SV-05-Q. Software Validation Report (Question) ●
- SV-05-A. Software Validation Report (Answer) .
- � TR-EI-025-Starting Up Test
- . TR-E1-026-Printing Reports Test
- . TR-EI-027-Email Test
- TR-EI-028- CareSens N Download Readings Test
- TR-EI-029-Manual Entry Test
- TR-EI-030-User Profile Test
- TR-EI-031-Reports Test
- TR-EI-060-Install Test
- TR-EI-085-CareSens Communication Protocol .
- . TR-EI-113-CareSens II Download Readings Test
- Proposed Labeling: The labeling is sufficient and it satisfies the requirement of 21 CFR Part R. 809.10.
- The submitted information in this premarket notification is complete ડ. Conclusion: and supports a substantial equivalence decision.
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
I-Sens, Inc. c/o Hyun Oh 465-6 Wolgye-Dong, Nowon-Gu, Seoul, 139-845 KS - REPUBLIC OF KOREA
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 2 1 2010
Re: K100937
Trade/Device Name: PC care Blood Glucose Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system, Regulatory Class: II Product Code: NBW, JOP Dated: November 19, 2010 Received: November 19, 2010
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 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).
.
12
Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
13
Indications for Use Form
510(k) Number (if known): ≤≤100937
Device Name: The PC care™ Blood Glucose Data Management Software Indications for Use:
The PC care Blood Glucose Data Management Software is PC-based software 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 PC care™ Blood Glucose Data Management Software connects to an i-SENS blood glucose meter, which comes with a PC care USB cable. The PC care " Blood Glucose Data Management Software allows the user to download Blood glucose readings automatically from the meter to the PC.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
GARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/00937
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