ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

K081318 · Lifescan, Inc. · NBW · Jun 9, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081318
• Device Name: ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The OneTouch Zoom Diabetes Management Program is intended for use by patients with diabetes to track and manage their blood glucose data.

Device Story

Web-based diabetes management application; retrieves blood glucose data from Microsoft HealthVault; provides trending and reports for diabetes management. Includes stand-alone software driver (OneTouch Meter Drivers) to download data from LifeScan blood glucose meters to Microsoft HealthVault Connection Center. Used in home and clinical settings by patients and healthcare professionals. Healthcare providers review generated reports to evaluate historical glucose data, supporting clinical decision-making and diabetes management. System architecture is .NET-based client/server; runs on Windows 2003 server; client supports Internet Explorer 6.0+. Drivers support Windows XP SP2 and Windows Vista.

Clinical Evidence

No clinical data; bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) and ISO-14971 risk analysis.

Technological Characteristics

Web-based .NET client/server application. Connectivity via Internet to Microsoft HealthVault. Software-based data management and reporting. No change to fundamental scientific technology or material composition.

Indications for Use

Indicated for people with diabetes and healthcare professionals in home and clinical settings to review, analyze, and evaluate historical blood glucose test results to support diabetes management. Used as an accessory to LifeScan blood glucose monitoring systems.

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

• OneTouch® Diabetes Management Software

Submission Summary (Full Text)

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Special 510(k)

JUN - 9 2008

# OneTouch® Zoom™ Diabetes Management Program

## 510(k) Summary

Sponsor LifeScan, Inc. 1000 Gibraltar Drive

Milpitas, CA 95035 U.S.A.

#### Correspondent

Primary 510(k) Contact: Frank Peralta LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Phone: [phone] e-mail: [e-mail]

Alternate 510(k) Contact: Mary Ellen Holden LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Phone: [phone] E-mail: [e-mail]

#### Device Name and Classification

OneTouch® Zoom™ Diabetes Management Program Common name: Glucose test system Classification: OneTouch® Zoom™ Diabetes Management Programa Class II device (21 CFR § 862.1345)

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### Product Description

The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management.

The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account.

The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side.

The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.

#### Predicate Device

OneTouch® Diabetes Management Software

#### Intended Use

The ONE TOUCH® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.

#### Comparison to Predicate Device

The modifications to the device encompass:

- . Reports: a reduction in the number of reports from eleven to two.
- . Data Storage: a change in data storage on a local database stored on the user's PC to a remote database hosted by Microsoft Corporation. connected via the Internet.

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OneTouch® Zoom™ Diabetes Management Program

There has been no change to the intended use, operating principle, functionality, or material composition of the device.

#### Technological Characteristics

There has been no change to the fundamental scientific technology.

#### Summary of Performance Characteristics

There has been no change to the performance characteristics of the product.

Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device.

#### Conclusion

The OneTouch® Zoom™ Diabetes Management Program is substantially equivalent to the predicate OneTouch Diabetes Management Software.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN - 9 2008

LifeScan, Inc. Mr. Frank Peralta Senior Regulatory Submissions Specialist 1000 Gibraltar Drive Milpitas, CA, 95035-6312

Re: K081318

Trade/Device Name: OneTouch® Zoom™ Diabetes Management Program Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: May 9, 2008 Received: May 12, 2008

Dear Mr. Peralta:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., D.V.M. 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):

K081318

ONE TOUCH® Zoom™ Diabetes Management Program Device Name:

#### Indications for Use:

The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.

| Prescription Use | |
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| (Per 21 CFR 801 Subpart D) | |

AND/OR

Over-the-Counter Use***_***_

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