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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TheraSense FreeStyle™ Connect Data Management System:

Summary of Acceptance Criteria and Study Information for TheraSense FreeStyle™ Connect Data Management System

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial results with acceptance criteria in the manner one might find for a novel diagnostic algorithm.

The core of the "study" described here is software verification and validation testing, confirming that the data management system functions as intended and meets specified performance requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (data management software) and the document (510(k) summary), the "acceptance criteria" are related to software functionality and safety rather than a diagnostic performance metric like sensitivity or specificity. The reported performance is adherence to these software development and testing standards.

Acceptance Criteria (Inferred from Text)	Reported Device Performance
Developed in accordance with TheraSense Inc. Software Development Procedures	Software developed in accordance with procedures.
Developed in accordance with FDA's Guide on Review of 510(k)s for Computer Controlled Medical Devices (1991)	Software developed in accordance with this guide.
Developed in accordance with Guidance for Content of Premarket Submission for Medical Devices Containing Software (May 29, 1998)	Software developed in accordance with this guidance.
Developed in accordance with General Principles of Software Validation (draft, 1997), where applicable and appropriate	Software developed in accordance with this draft guidance.
Software Verification Testing demonstrates meeting performance requirements for intended use	Software verification testing demonstrates meeting performance requirements.
Software Verification and Validation testing completed and results conform to functional requirements	Will be completed, and results will conform (commitment).
Safe and effective for its intended use (as demonstrated by verification testing)	Software verification testing demonstrates safety and effectiveness.
Substantially Equivalent to predicate device (MediSense Precision Link Data Management System K952279)	FDA determination of Substantial Equivalence (K994433).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical accuracy. The testing described is software verification and validation. Therefore:

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set. The validation would involve various software testing scenarios, test cases, and simulated data, but not a specific "sample size" of patient data for accuracy measurement.
Data Provenance: Not applicable. The validation focuses on the software's functionality, data transfer, storage, display, and analysis capabilities rather than the origin of clinical data used for accuracy assessment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. For software verification and validation, the "ground truth" is defined by the software specifications, functional requirements, and relevant regulatory guidance. Software engineers, quality assurance personnel, and potentially medical device experts (to interpret regulatory requirements) would be involved in the design and review of these tests.
Qualifications of Experts: Not explicitly stated, but typically involves software developers, quality assurance engineers, and regulatory affairs specialists.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Software verification and validation results are typically determined by comparing the software's output/behavior against predefined expected outcomes based on the software specifications. There is no mention of a human adjudication process for test results in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed or described. This type of study is typically done for diagnostic imaging devices where human readers interpret results with or without AI assistance. The FreeStyle™ Connect Data Management System is data management software, not a diagnostic imaging AI.
Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable, as no such study was conducted. The software aims to "aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results," implying an improvement in data management and insight, but not through an AI diagnostic assistance paradigm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, in essence, the software verification and validation described is a "standalone" evaluation of the algorithm's (software's) functionality. It demonstrates that the software itself performs its intended data management tasks (transfer, storage, display, analysis) correctly according to its specifications, independent of a specific human-in-the-loop diagnostic interpretation. However, its intended use is to "aid" human users, so its ultimate value is realized with human interaction. The validation focuses on the technical correctness of the software's operations.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used for software verification and validation is primarily software specifications, functional requirements, and regulatory guidance. The software's output and behavior are compared against these documented requirements to confirm correct operation. For data-handling aspects, the ground truth would be the original data from the FreeStyle™ Blood Glucose Meter.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The FreeStyle™ Connect Data Management System is a rule-based software that processes and displays data. It is not an AI/ML model that requires a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of software.

Summary

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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, Inc1360 South Loop RoadAlameda, 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 ManagementSystem	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

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

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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.

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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

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TheraSense Inc.

INDICATIONS FOR USE STATEMENT

K994433

510(k) Number:

Device Name: FreeStyle™ Connect Data Management System

Not Assigned

Indications for Use:

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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

Over-the-Counter Uses

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.