The TheraSense, Inc., FreeStyle Blood Glucose Monitoring 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and 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.

Device Description

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (bee) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liguid crystal display (LCD).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FreeStyle Blood Glucose Monitoring System:

The provided document, a Premarket Notification Labeling Modification for the FreeStyle Blood Glucose Monitoring System, is very brief and does not contain the detailed information requested about acceptance criteria and comprehensive study results. It primarily focuses on the labeling modification to include the palm as an alternative test site.

Therefore, many of the requested fields cannot be filled from the given text.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of accuracy or precision metrics for the blood glucose monitoring system itself. It only mentions a clinical study performed to support a labeling change.

Acceptance Criteria (Not Explicitly Stated for Device Performance in Glucose Measurement)	Reported Device Performance (Regarding Equivalence of Rapid Glucose Change Sites)
Not specified in the provided text. Acceptance criteria for glucose measurement accuracy (e.g., ISO 15197 standards) are generally required for glucose monitoring systems, but are not detailed here.	Clinical study demonstrates that during times of rapid glucose change, palm and fingertip glucose values are the same.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions a "clinical study data," but does not provide details on:

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin).
Study design: It states "The clinical study data demonstrate... This study confirms results in several published reports...", which implies it was a prospective study conducted to gather new data to confirm existing literature, but does not explicitly state "prospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a blood glucose monitoring system, and the "ground truth" for glucose levels is typically established by a reference laboratory method, not by expert interpretation. The text does not describe the method for establishing reference glucose values.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used when subjective interpretations are involved (e.g., reading medical images). For quantitative measurements like blood glucose, adjudication of results is generally not performed in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone medical device (blood glucose meter), not an AI-assisted diagnostic tool involving human readers interpreting outputs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device itself (the FreeStyle Blood Glucose Monitoring System) is a standalone measurement device. It provides quantitative glucose readings directly. The study mentioned focuses on comparing glucose values obtained from different body sites using this standalone device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "ground truth" method used for the glucose measurements. For blood glucose meters, the ground truth is typically established by an accurate laboratory reference method (e.g., YSI analyzer). The study aimed to show equivalence between two measurement sites, rather than absolute accuracy against an external gold standard.

8. The sample size for the training set

Not applicable. This document describes a clinical study for a traditional medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model described here.

Summary

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DEC 1 9 2003

TheraSense Inc.

Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003

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 K03/260

1. Device Name

Classification Name:	Glucose Test System (§ 862.1345)
Common/Usual Name:	Blood Glucose Meter and Reagent Test Strips
Proprietary Names:	Freestyle™Blood Glucose Monitoring SystemAnd FreeStyle Tracker Diabetes Management System

Legally Marketed Devices to which Substantial equivalence is Claimed: 2.

Predicate Device	510(k) Number
FreestyleTM Blood Glucose Monitoring System	K992684
	K000582
	K012014
FreeStyle Tracker Diabetes Management System	K020866

3. Device Description

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc.

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TheraSense Inc.

4. Intended Use of the Device

FreeStyle Blood Glucose Monitoring System

FreeStyle Tracker Diabetes Management System

The TheraSense, Inc., FrecStyle 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

Principle of Operation న్.

The user obtains a blood sample using a conventional lancing technique on the finger or arm. The user inserts a test strip into the meter, which turns the meter on. When the strip is touched to the blood drop, the sample chamber on the strip tills by capillary action in approximately 2 seconds. The blood sample volume required is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger or other areas of the body such as the arm. Test results are displayed in about 15 seconds. The time required to

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc.

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TheraSense Inc.

Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003

display test results varies depending on the blood glucose concentration (approximately 15 to 45 seconds).

The glucose in the blood sample reacts with the glucose Dehydrogenase enzyme to yield gluconolactone, and produces a small electrical current. This current is measured by the FreeStyle meter and displayed as a glucose level.

6. Conclusion Drawn from Clinical Test Demonstrating Substantial Equivalence

The clinical study data demonstrate that during times of rapid glucose change, palm and fingertip glucose values are the same. This study confirms results in several published reports which show the equivalence of fingertip and palm glucose test results under conditions of rapid glucose change. The combination of TheraSense's confirmatory study and published support TheraSense's proposed labeling change to recommend the palm of the hand as an alternative test site even under conditions of rapidly changing blood glucose.

Proprietary Data: This document and the information contained herein may not be reproduce used or disclosed without prior written consent of TheraSense, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2003

Ms. Donna K. Templeman Director, Regulatory Affairs TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502

K031260 Re:

Trade/Device Name: FreeStyle Blood Glucose Monitoring System and Tracker Diabetes Management System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR; JJX Dated: September 16, 2003 Received: September 22, 2003

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 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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Page 2 -

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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TheraSense Inc.

Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003

Intended Use Statement

510(k) Number (if known):

Device Name:

K03/260

FreeStyle Blood Glucose Monitoring System and Tracker Diabetes Management System

Indication for Use:

FreeStyle Blood Glucose Monitoring System

FreeStyle Tracker Diabetes Management System

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, and evaluation of historical blood glucose test results to support an effective diabetes management program.

The TheraSensc, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

Use

Carol C. Benson/s Jean Cooper, DVM
Division Sign-Off

(Optional Format 1-2-96)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031260

Proprietary Data: This document and the information contained herein may not be reproduced used or disclosed without prior written consent of TheraSense, Inc.

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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.