THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)

K061328 · E-San Limited · NBW · Jun 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061328
• Device Name: THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
• Applicant: E-San Limited
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The intended use of the t+ Diabetes System is for transmission and storage of blood glucose data obtained from a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.

Device Story

e-San Bluetooth Cradle acts as a wireless communication accessory for LifeScan OneTouch Ultra Blood Glucose Monitoring System; connects via 3.5mm stereo plug to meter serial port; utilizes Bluetooth V1.2 to transmit glucose measurement data to Bluetooth-enabled cellular phones (e.g., Nokia 6230). Device enables patient diary application on phone; facilitates data transfer to remote internet-based database for storage and display. Intended for home use by patients. Battery-powered with power-saving features (auto-off, remote-shutdown, RF TX power control). Device provides transparent serial cable replacement; does not perform glucose testing itself.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bluetooth cradle; Bluetooth V1.2 wireless transmission; connects to LifeScan OneTouch® Ultra® Blood Glucose Monitoring System; compatible with Bluetooth-enabled cellular phones; data transmission to remote database via internet.

Indications for Use

Indicated for home use by patients to wirelessly transmit blood glucose data from a LifeScan OneTouch Ultra meter to a Bluetooth-enabled cellular phone for storage, display, and remote database transmission.

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

• t+ Diabetes System (K052343)

Submission Summary (Full Text)

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# 510(k) SUMMARY

JUN 1 3 2006

# Think Positive (t+) Diabetes Management System

Common/Classification Name:

Accessory to Blood Glucose Test System 21 CFR 862.1345

> Sponsor: e-San Ltd. Attn: Neil Townsend, D.Phil. Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom

Contact: Becker & Associates Consulting, Inc. Attn: Kristin M. Zielinski 2001 Pennsylvania Avenue NW, Suite 575 Washington, DC 20006

### A. Legally Marketed Predicate Device

The modified t+ Diabetes System is substantially equivalent to the previous version of the device (K052343).

#### B. Device Description

The e-San Bluetooth Cradle is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and uses short-range low power wireless transmission (Bluetooth V1.2) to send the data to a Bluetooth compatible cellular telephone such as the Nokia Model 6230. The t+ Diabetes System allows the blood glucose data to be stored and displayed on a cell phone, and transmitted to a centralized database for storage and display.

## C. Intended Use

The intended use of the t+ Diabetes System is for transmission and storage of blood glucose data obtained from a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.

CONFIDENTIAL

0023

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# D. Substantial Equivalence Summary

The t+ Diabetes System has the same fundamental scientific technology and intended use as the predicate device.

### E. Conclusions

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(l) of the Federal Food, Drug, and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 3 2006

e-San Limited c/o Ms. Kristin M. Zielinski Project Manager Becker & Associate Consulting, Inc. 2001 Pennsylvania Avenue NW, Suite 575 Washington, DC 20006

- Re: k061328
Trade/Device Name: Think Positive (t+) diabetes Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 12, 2006 Received: May 12, 2006

Dear Ms. Zielinski:

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G.

Alberto Gutierrez, 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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# Indications for Use

510(k) Number (if known): K061328

Device Name: Think Positive (t+) Diabetes Management System

Indications For Use:

The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230.

The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone.

The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kob1328

CONFIDENTIAL