(127 days)
Not Found
No
The description focuses on data transfer and basic data management for glucose results, with no mention of AI/ML terms or functionalities like predictive analysis or pattern recognition beyond simple data display.
No
The device is a data management system that aids in the review, analysis, and evaluation of glucose test results; it does not directly treat or prevent a disease.
No
The device is a data management system that aids in the review, analysis, and evaluation of glucose test results to support diabetes management. It does not perform a diagnostic function itself, but rather organizes and presents data for healthcare professionals to interpret.
Yes
The device is described as "optional data management software accessory" and its function is to transfer data from a blood glucose meter to a personal computer for data management. The performance studies focus on software verification and validation, indicating it is a software-based system.
Based on the provided information, the TheraSense Inc. FreeStyle™ Connect Data Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "review, analysis and evaluation of glucose test results". It aids in the management program, but it does not perform the diagnostic test itself. The diagnostic test (measuring glucose) is performed by the FreeStyle™ Blood Glucose Monitoring System, which is a separate device.
- Device Description: It is described as an "optional data management software accessory" that "permits the transfer of data". This reinforces its role as a tool for managing data from a diagnostic device, not a diagnostic device itself.
- No mention of performing a diagnostic test: The description focuses on data transfer and management, not on the process of analyzing a biological sample to determine a medical condition.
In summary, the FreeStyle™ Connect Data Management System is a software tool that works with an IVD (the blood glucose meter) to help users and healthcare professionals manage the data generated by the IVD. It does not perform the in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The TheraSense Inc. 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.
Product codes (comma separated list FDA assigned to the subject device)
LFR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
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.(b)
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.
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
1360 South Loop Road
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.
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| Predicate Device | 510(k) number |
|---|---|
| MediSense Precision Link Data Management | |
| 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.
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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
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)