Who is the manufacturer of PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

I-Sens, Inc. filed the 510(k) submission for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE (K100937).

What is the FDA product code for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

NBW. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

Zero-Click™ Data Management System (k062434).

Who can help prepare an FDA 510(k) submission like PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

K100937 · I-Sens, Inc. · NBW · Dec 21, 2010 · Clinical Chemistry

Device Facts

Record ID	K100937
Device Name	PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
Applicant	I-Sens, Inc.
Product Code	NBW · Clinical Chemistry
Decision Date	Dec 21, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2
Attributes	Software as a Medical Device

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.

Device Story

PC care™ Blood Glucose Data Management Software is a PC-based application for managing blood glucose data. It interfaces with i-SENS blood glucose meters via a proprietary USB cable. The software automatically downloads test results, including measurement dates and times, from the meter to a personal computer. Users or healthcare professionals utilize the software to generate graphic displays, reports, and statistics based on user-selectable data intervals and target glucose ranges. It supports manual data entry, health profile tracking, and insulin/medication logging. The software is intended for use in home and professional clinical settings to assist in diabetes management programs. Healthcare providers use the generated reports to evaluate trends and changes in blood glucose levels, facilitating clinical decision-making regarding patient therapy.

Clinical Evidence

Bench testing only. Software validation was performed to verify system functionality, including data download, manual entry, user profile management, and report generation. No clinical studies were required or performed.

Technological Characteristics

PC-based software operating on Microsoft Windows (95 through 7, 32-bit). Connectivity via proprietary USB cable to i-SENS blood glucose meters. System requirements: 300 MHz Pentium 2, 128 MB RAM, 60 MB disk space. Standards referenced: FDA Guidance for Software in Medical Devices, ISO 15197:2003.

Indications for Use

Indicated for people with diabetes and their healthcare professionals in home and professional settings to review, analyze, and evaluate blood glucose test results for diabetes management.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Zero-Click™ Data Management System (k062434)

Related Devices

K133346 — SMARTLOG DIABETES MANAGEMENT SOFTWARE · I-Sens, Inc. · Dec 19, 2013
K101371 — ON CALL PLUS DIABETES MONITORING SOFTWARE · ACON Laboratories, Inc. · Jan 7, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ K100937 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. 1) 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 | |…