CONNECT DATA MANAGEMENT SYSTEM

{0}------------------------------------------------ TheraSense Inc. **MAY - 5 2000** Image /page/0/Picture/3 description: The image shows the logo for TheraSense. The logo features a stylized human figure with outstretched arms, suggesting a sense of openness and care. To the right of the figure, the word "THERASENSE" is written in a bold, sans-serif font, and below it, the tagline "The Technology of Caring" is written in a smaller, lighter font. ## 510(k) SUMMARY This summary of 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 Not Assigned ## 1. Sponsor's Name, Address, Telephone Number and Contact Person | Sponsor: | TheraSense, Inc<br>1360 South Loop Road<br>Alameda, CA 94502 | |-----------------|--------------------------------------------------------------| | Contact Person: | Eve A. Conner, Ph.D. | | Telephone: | (510) 749-5406 | | Facsimile: | (510) 749-5401 | ### 2. Device Name | Classification Name: | None1,2 | |----------------------|-------------------------------------------| | Common/Usual Name: | Data Management Software | | Proprietary Names: | FreeStyle™ Connect Data Management System | #### Legally Marketed Devices to which Substantial Equivalence is Claimed: 3. The FreeStyle™ Connect Data Management System is considered an "unclassified" accessory to a blood glucose test system, Product Code 75LFR, Glucose Dehydrogenase. ² The device regulation for a "calculator/data processing module for clinical use", 21 CFR 862.2100, exempts Inch Class I devices from 510(k) Premarket Notification requirements. However, this regulation applies to data Such Class I acriets from 910(th) as a mot home use. The regulation for the parent device (blood glucose monitor, Class II) is 21 CFR 862.1345, glucose test system. {1}------------------------------------------------ | Predicate Device | 510(k) number | |----------------------------------------------------|---------------| | MediSense Precision Link Data Management<br>System | K952279 | ### 4. Intended Use of the Device The TheraSense FreeStyle™ Connect Data Management System is intended for use in home and clinical 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. ### 5. Device Description The FreeStyle™ Connect Data Management System is an optional data management software accessory for use with the FreeStyle™ Blood Glucose Monitoring System. The FreeStyle™ Connect Data Management System permits the transfer of data from the FreeStyle™ Blood Glucose Meter to a personal computer for enhanced data management capability. ### 6. Principle of Operation The FreeStyle™ Blood Glucose Connect Data Management System retrieves each blood glucose test result and the date and time of the measurement from the memory of the FreeStyle™ Blood Glucose Meter via a direct serial cable connection between the Freestyle™ Meter and the personal computer. The FreeStyle™ Blood Glucose Data Management Software operates in a Microsoft® Windows Operating System platform. The FreeStyle™ Blood Glucose Data Management Software creates a patient record in the database to {2}------------------------------------------------ store the transmitted data or adds new data to an existing record. The FreeStyle™ Blood Glucose Data Management Software allows the user to display a variety of graphs and statistics based on user-selectable date intervals, time of day segments, blood glucose target ranges. The FreeStyle™ Connect Data Management System stores the patient data, patient-specific time of day segments, and patient-specific blood glucose target ranges in the patient file. ## 7. Summary of Data Demonstrating Substantial Equivalence Software for the FreeStyle™ Connect Data Management System has been developed, verified and will be fully validated in accordance with TheraSense Inc. Software Development Procedures. In addition, the FreeStyle™ Connect Data Management System software has been developed in accordance with the FDA's Guide on the Review of 510(k)s for Computer Controlled Medical Devices (1991), Guidance for the Content of Premarket Submission for Medical Devices Containing Software (May 29, 1998) and General Principles of Software Validation (draft, 1997), where applicable and appropriate. Software verification testing demonstrates that the FreeStyle™ Connect Data Management System meets the performance requirements for the intended use of the device. Software Verification and Validation testing will be completed and the results will conform to the functional requirements specified in the software specifications before the FreeStyle™ Connect Data Management System will be released for commercial distribution. #### 8. Conclusions Software verification testing demonstrates that the TheraSense FreeStyle™ Connect Data Management System is safe and effective for its intended use. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they resemble a bird in flight. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. ## MAY = 5 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Eva A. Connor, Ph.D. Vice President Quality Assurance and Regulatory Affairs TheraSense Inc. 1360 South Loop Road Alameda, California 94502 Re: K994433 > Trade Name: FreeStyle™ Connect Data Management System Regulatory Class: II Product Code: LFR Dated: April 5, 2000 Received: April 6, 2000 Dear Dr. Connor: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ #### 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 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 {5}------------------------------------------------ TheraSense Inc. # INDICATIONS FOR USE STATEMENT K994433 510(k) Number: Device Name: FreeStyle™ Connect Data Management System Not Assigned ### Indications for Use: The TheraSense Inc. FreeStyle™ Connect Data Management System is intended for the The TheraSense the. I receityle - Goldioce with diabetes and health care use in home and chinear settings to and people wisher of historical blood glucose test professionals in the review, analysis, and evaluation of historical professionals in the review, and jees, results to support an effective diabetes management program. Aian Coops (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K994433 ## (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 Uses (Per 21 CFR 801.109)