ON CALL PLUS DIABETES MONITORING SOFTWARE

K101371 · ACON Laboratories, Inc. · NBW · Jan 7, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101371
• Device Name: ON CALL PLUS DIABETES MONITORING SOFTWARE
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meters for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Device Story

Software accessory for On Call® Plus Glucose Meters; transfers glucose data to PC via USB or RS232 cable. Used in home or clinical settings by patients or healthcare professionals. Features 'Home' version for single-user tracking and 'Professional' version for multi-provider/multi-patient database management. Transforms raw meter data into tables, line charts, bar charts, and pie charts (e.g., average day/week reports). Does not provide medical advice or dosage recommendations. Enables password-protected database management; allows configuration of glucose target levels and time periods. Benefits patients and providers by facilitating glucose trending and data visualization for diabetes management.

Clinical Evidence

Clinical usability study conducted with lay persons. Participants performed software installation, data transfer, setting configuration, database management, and report generation. Results demonstrated that inexperienced users could successfully operate the software and obtain glucose trending reports. Users reported satisfaction with ease of operation and performance.

Technological Characteristics

System requirements: Pentium processor, USB/RS-232 port, 128MB RAM, 70MB disk space. Compatible with Windows 2000, XP, Vista, 7. Data transfer via USB/RS232 TTL cable. Features password-protected databases, multi-user/multi-provider support, and configurable glucose target levels. Complies with EN 62366:2008 (usability) and EN 62304:2006 (software life cycle).

Indications for Use

Indicated for use by patients with diabetes or healthcare professionals to transfer, organize, and visualize blood glucose data from On Call® Plus Glucose Meters. Suitable for home and clinical settings.

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

• Glucofacts® Deluxe Diabetes Management Systems (K091820)

Submission Summary (Full Text)

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#### ડ. 510(k) Summary

The summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

#### Submitters Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel: [phone] Fax: [phone]

Date prepared: May 7th, 2010

#### Contact Person:

Richard Lenart Regulatory Affairs Manager

### Proprietary Name of the Device:

On Call® Plus Diabetes Monitoring Software

#### Common name:

Diabetes Software

#### Classification Name:

Class I §862.2100 Calculator/data processing module for clinical use. Class II §862.1345 Glucose Test System (To be manufactured and marketed for consumer home and professional use)

# Predicate Device:

Glucofacts® Deluxe Diabetes Management Systems Bayer Healthcare 430 South Beiger Street, Mishawaka, IN 46544 510(k) K091820

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Device name: On Call® Plus Diabetes Monitoring Software

| Proprietary Name | Classification | Product<br>Code | Description | Common Name |
|-----------------------------------------------------|------------------------|-----------------|-----------------------------------------------------|----------------------|
| On Call® Plus<br>Diabetes<br>Monitoring<br>Software | §862.1345<br>§862.2100 | NBW,<br>JQP | System, Test,<br>Blood Glucose,<br>Over The Counter | Diabetes<br>Software |

# Description:

The On Call® Plus Diabetes Monitoring Software is for downloading glucose data from the On Call Plus meter to a PC through an USB to RS232 TTL level cable or RS232 to RS232 TTL level cable, with tracking and trending capabilities of glucose measurements.

The Diabetes Data Management Software is intended to be used in a clinical setting with multiple patients by a healthcare professional, or directly by the patient.

The user has the choice to install either a personal "Home" or "Professional" version. In the "Home" version, glucose results are assembled for a single user. In the "Professional" version, the software user can configure a database with multiple providers and patients. The number of providers, patients and data points is limited only by the computer's capabilities.

# Intended Use:

The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meters for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

# Technological Characteristics:

| Feature | Specification |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Requirements | Pentium or equivalent processor, USB or RS-232 9-pin serial port<br>128 MB memory, 70 MB hard drive space, minimum 800 x 600<br>display, CD-ROM drive |
| Operating Systems | Microsoft Windows 2000, XP Home/Professional, Vista, windows 7 |
| Reports, Charts and Graphs | Data list report, line, bar and pie charts, average day line chart,<br>average day/week bar charts. |
| Glucose Units of Measure | millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) |
| Users | Multiple users and patients limited only by the capabilities of the<br>computer being used |
| Passwords | Create databases that are password protected |

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| Delete Memory | comparent proposes and proposations and proposes and charges of confessional con-<br> Can delete patients, providers, databases and data stored in meters |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| www.comment.com/sports/collection/com/com/demail/collection/close- | |

Comparison to Predicate Device:
The On Call® Plus Diabetes monitoring Software is substantially equivalent to
Glucofacts® Deluxe Diabetes Management Softwa

| Features | On Call® Plus Diabetes Monitoring<br>Software | Glucofacts® Deluxe Diabetes<br>Management Software<br>(K091820) | | | |
|------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------|--|--|--|
| Similarities | | | | | |
| COM Ports scan | Automatic scan for connected ports | Same | | | |
| Multiple patients | Can list data for multiple patients | Same | | | |
| Data list/ Summary<br>report | List of all readings inside selected<br>time frame | Same | | | |
| Reports and charts | Data List, Log Book report, Standard<br>Day report, Trend report, Pie charts | Same | | | |
| Target levels | High, low, hyper and hypo glucose<br>target levels can be changed | Same | | | |
| Time periods | Daily time periods can be changed | Same | | | |
| Units of measure | Can choose either mmol/L or mg/dL | Same | | | |
| Data Base | Can Set up multiple patient data bases | Same | | | |

| Differences | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Change Meter<br>settings | Does not allow change to meter<br>settings through the Diabetes<br>Monitoring Software | Allows target range, alarm sounds<br>and optional level changes to<br>supported meters through the<br>Management Software | | | |
| Operating System | Microsoft Windows 2000, XP<br>Home/Professional, Vista, windows 7 | Microsoft Windows XP, Vista or<br>Mac OS 10.5.7 or later (Mac is only<br>an option with the Contour USB<br>meter) | | | |
| Associate a meter to<br>a person | No association | Software can be set to recognize<br>meters and associate them to<br>specific patients | | | |
| Standard week<br>report | No Standard Week report | A graph that displays all readings<br>by day overlapping all the days on<br>a one week graph | | | |
| Average Week | A bar graph that averages all<br>readings for each day by day of the<br>week, Sunday through Saturday and<br>before and after meals. | No average week report | | | |
| Average Day | A bar graph that averages all readings<br>for each day by time slot and before<br>and after meals. | No average day report | | | |
| Password | Allows providers accounts to be<br>password protected | Does not have password protection<br>on the software | | | |
| Providers | Allows for multiple providers each<br>with their own data base of patients | Does not have providers but does<br>allow for multiple databases | | | |

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# Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: '

The performance characteristics of the On Call® Plus Diabetes Monitoring Software were evaluated by performing the software validation test. Guidance documents included "Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff." Compliance to applicable voluntary standards includes EN 62366:2008, "Medical devices, Application of usability engineering to medical devices" and EN 62304:2006 "Medical device software, Software life cycle processes."

# Discussion of Clinical Tests Performed:

Clinical studies were conducted with lay persons using the On Call® Plus Diabetes Monitoring Software to demonstrate that the intended user can easily operate the software features including Installing the software, transferring meter data to the computer, changing settings, setting up providers and patients, using passwords, viewing and printing reports and uninstalling the software.

Study results indicate that non-professional, inexperienced lay persons were able to operate the software and obtain glucose trending reports. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the User's Manual and the overall performance of the On Call® Plus Diabetes Monitoring Software.

# Conclusion:

The laboratory testing and clinical study results demonstrate that the On Call® Plus Diabetes Monitoring Software is safe, effective and easy-to-use. It demonstrates that the On Call® Plus Diabetes Monitoring Software meets all the validation and clinical requirements and is substantially equivalent to the Baver Glucofacts Deluxe Diabetes Management Software sold on the U.S. market (K091820).

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circle's perimeter.

Acon Laboratories, Inc. c/o Richard Lenart 10125 Mesa Rim Rd., San Diego, CA 92121

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JAN 07 2011

Re: k101371

Trade/Device Name: On Call Plus Diabetes Monitoring Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW. JOP Dated: December 3, 2010 Received: December, 6, 2010

Dear: Mr. Lenart:

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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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 [phone]. 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 Biometrio's (OSB's) Division of Postmarket Surveillance at [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

Courtney C. 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

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#### 4. INDICATIONS FOR USE

510(k) number (if known): k101371

JAN - 7 2011

Device Name: On Call® Plus Diabetes Monitoring Software

Indications for Use:

The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Prescription Use (Part 21 CFR 801 Subpart D) C) .

AND/OR

Over-The-Counter Use_ X (21 CFR 807 Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety Page I of _ l _ _ l

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510(k) K10137