FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM

{0}------------------------------------------------ TheraSense, Înc. March 15, 2002 KO20866 FreeStyle Tracker Diabetes Management System Special 510(k)- Device Modification JUN 11 2002 | 510(k) Summary | JUN 11 2002 | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Category | Comments | | Sponsor: | TheraSense, Inc.<br>1360 South Loop Road<br>Alameda, CA 94502 | | Correspondent: | Donna K. Templeman<br>Manager, Regulatory Affairs<br>1360 South Loop Road<br>Alameda, CA 94502 | | Contact Numbers: | Phone: (510) 239-2670<br>Fax: (510) 239-2799 | | Device Common Name | Blood Glucose Meter and Data Management<br>Software | | Device Proprietary Name | FreeStyle Tracker™ Diabetes Management<br>System | | Device Classification Name | Glucose Test System<br>Blood Lancet | | Device Classification | Glucose Test System per 21 CFR 862.1345,<br>Class II Device | | Predicate Device | TheraSense, Inc., FreeStyle Blood Glucose<br>Monitoring System<br>TheraSense, Inc., FreeStyle Connect Data<br>Management System | | Predicate Device<br>Manufacturer(s) | TheraSense, Inc. | | Predicate Device<br>Reference(s) | K992684; K000582; K012014; K994433 | | Predicate Device<br>Proprietary Name(s) | TheraSense, Inc., FreeStyle Blood Glucose<br>Monitoring System<br>TheraSense, Inc., FreeStyle Connect Data<br>Management System | | Predicate Device<br>Classification Name(s) | Glucose Test System<br>Data Management Software | | Predicate Device<br>Classification(s) | Glucose Test System per 21 CFR 862.1345, Class<br>II Device<br>Data Management Software, no classification<br>exists as of the date of subject device filing. | Date Summary Was Prepared: March 15, 2002. > Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc {1}------------------------------------------------ ## Description of the Device: The FreeStyle Tracker Diabetes Management System combines and joins the technologies and capabilities of both the FreeStyle Blood Glucose Monitoring System (blood glucose measurement testing system) and the FreeStyle Connect Data Management System (data management accessory software). Through the use of a Personal Digital Assistant (PDA), the user is able to conveniently log glucose measurements directly to a log history on the PDA. The Tracker System eliminates the necessity for manual data logs and separate tools for calculating values, storing results and producing and maintaining critical medical records. The blood glucose meter and data management system components of the Tracker System can also be used independently as separate features. The items that comprise the FreeStyle Tracker Diabetes Management System are as follows: - . FreeStyle Tracker Measurement Module - Personal Digital Assistant (PDA) . - . "Hot-sync" Cradle - FreeStyle Tracker Data Management Software . Additionally, in order to perform a blood glucose test the Tracker System requires the following items. These items are the same as those needed for the current FreeStyle System: - . FreeStyle Test Strips - FreeStyle Lancing Device . - FreeStyle Lancets ● - FreeStyle Control Solution . To perform a blood glucose measurement, the user removes the cover of the Visor PDA expansion slot and inserts the Tracker Measurement Module into the Visor PDA Handspring slot. The user then inserts a test strip into the Measurement Module. The user acquires a blood sample (with the test strip in the meter) by touching the edge of {2}------------------------------------------------ ### TheraSense, Inc. March 15, 2002 the test strip to the blood target area, filling the chamber on the strip by capillary The Tracker System sounds a tone (beeps) to let the user know that the action. sample chamber is full and the reaction has begun. The test is complete and the meter displays the glucose reading on the PDA display. The Tracker Data Management Systems also gives the ability to conveniently access and maintain diabetes data through the Visor PDA and/or PC. The user can easily and conveniently track major factors that affects their diabetes health, for example: - Blood glucose levels - . Insulin usage (via injection or pump) - . Food intake - Exercise . - . Oral medication usage - . State of health The Tracker DMS will also allow the user to enter personal factors used to maintain their proper glucose level. The following items assist the user to track and modify their lifestyle as it affects their diabetes health: - Target glucose range . - o Usual insulin type - . Typical insulin dose - . Insulin adjustment guidelines (determined by his/her healthcare professional) - . Meal schedule and guidelines (determined by his/her healthcare professional) - . Typical exercise type, duration and intensity Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc {3}------------------------------------------------ ## Intended Use: The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood. Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program. The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf, and hand. ## Technological ## Characteristics: The fundamental scientific technology of the FreeStyle System has not been modified to result in the Tracker Diabetes Management System. The Tracker Measurement Module contains the same technology as the FreeStyle Meter in that the Tracker Measurement Module measures the electrical output from the glucose in whole blood reacting with the FreeStyle Test Strip chemistry. The measurement is then converted into glucose concentrations and displayed to the user. > Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc {4}------------------------------------------------ ## Summary of # Testing: System and component testing was performed with the Tracker Diabetes Management System to ensure the new device is equivalent to the currently marketed devices (FreeStyle Blood Glucose Monitoring System and FreeStyle Connect Data Management Software). These tests consisted of system, hardware, software, mechanical, packaging, electrical safety (EMC, EMI, and ESD) and clinical (user's study and labeling comprehension) evaluations. The changes to the FreeStyle System have been verified and validated demonstrating that the resultant changes have not affected safety or effectiveness. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services (USA). The logo features a stylized image of a bird or abstract human figure, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the image. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service . Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Donna K. Templeman Manager, Regulatory Affairs TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502 JUN 11 2002 Re: k020866 Device Name: FreeStyle Tracker™ Diabetes Management System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW Dated: June 3, 2002 Received: June 4, 2002 Dear Ms. Templeman: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Autman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ TheraSense, Inc. March 15, 2002 # Intended Use Statement 510(k) Number (if known): K020866 #### FreeStyle Tracker Diabetes Management System Device Name: ## Indication for Use: The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates. Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program. The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf, and hand. Sen Cooper (Division Sign-Off) Vision of Clinical Laboratory....... 10(k) Number K020846 #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Proprietary Data: This document and the information contained herein may not be reproduced. used or disclosed without prior written consent of TheraSense, Inc.