The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia ® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Description

The Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) is used for the measurement of glucose in whole blood. The strip is one component of a system that also contains a meter, controls, lancing device, and instructions for use.

AI/ML Overview

The provided document is a 510(k) summary for the Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip). It compares the modified device to a predicate device and assesses its performance. However, it does not explicitly state specific acceptance criteria (e.g., in terms of mean absolute relative difference or error grids) with defined numerical thresholds. Instead, the assessment is based on demonstrating "equivalent performance" and "substantial equivalence" to the predicate device and a laboratory method.

Here's an attempt to structure the information based on the request, inferring what can be gathered from the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device and a laboratory method regarding blood glucose results.	"The studies showed equivalent performance with the original Ascensia® CONTOUR® Blood Glucose Monitoring System." "The results of the laboratory and clinical evaluations... demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device."

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states: "An evaluation of the Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) was studied in the laboratory and in a clinical setting by persons with diabetes."
- Sample Size: The exact sample size for the test set (number of patients or measurements) is not specified in the provided text.
- Data Provenance: The country of origin of the data is not specified. The study involved both "laboratory" and "clinical setting," and was conducted by "persons with diabetes," implying real-world usage, but the prospective/retrospective nature is not explicitly stated. It can be inferred as prospective for the clinical setting part.
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):
The ground truth was established by comparison to "a laboratory method" and the "original Ascensia® CONTOUR® Blood Glucose Monitoring System."
- Number of Experts: The document does not specify the number of experts.
- Qualifications of Experts: The qualifications of individuals performing the "laboratory method" are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe an adjudication method as it relates to expert consensus or discrepancies. The comparison was against a laboratory method and a predicate device.
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:
This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study is not applicable in this context, and no information on human reader improvement with AI is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is related to AI/algorithm performance. The device is a "Blood Glucose Monitoring System," which inherently involves a measurement system (modified test strip and meter). The evaluation focused on the performance of this system itself, comparing its measurements to existing methods. It's a standalone device in the sense that the measurement output is directly compared, rather than being an algorithm that assists a human.
However, if "standalone" refers to an algorithm without human intervention in interpreting the output, then the device itself is standalone in producing a glucose reading. The performance assessment was of the "Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip)" itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by:
- Comparison to results from the "original Ascensia® CONTOUR® Blood Glucose Monitoring System" (the predicate device).
- Comparison to "a laboratory method." This "laboratory method" would typically be a highly accurate and precise reference method for blood glucose measurement (e.g., YSI analyzer, hexokinase method), often considered the gold standard for glucose concentration.
The sample size for the training set:
The document describes an "evaluation" or "study" of the modified device. It does not mention a "training set" as would be relevant for machine learning algorithms. This device is a biochemical measurement system, not an AI/ML model that requires training.
How the ground truth for the training set was established:
As there is no mention of a "training set" for an AI/ML model, this question is not applicable.

Summary

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Bayer HealthCare Diabetes Care Division

APR 1 2 2006

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510(k) SUMMARY

Ascensia® CONTOUR® Blood Glucose Monitoring System (Modified Test Strip)

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	K060470
Prepared:	February 22, 2006
Submitter:	Bayer HealthCare, Diabetes Care Division
Address:	430 South Beiger StreetMishawaka, IN 46544Phone (574) 262-7152; FAX (574) 262 6945
Contact:	Roger Sonnenburg, Regulatory Affairs Manager
Device:	Trade/Proprietary Name: Ascensia® CONTOUR® BloodGlucose Monitoring System
Common/Usual Name:	Blood Glucose Meter
Classification:	Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 LFR, Glucose Dehydrogenase,Glucose
Predicate Devices:	Ascensia® CONTOUR® Diabetes Care System, K023657
Device Description:	The Ascensia® CONTOUR® Blood Glucose MonitoringSystem (modified test strip) is used for the measurement ofglucose in whole blood. The strip is one component of asystem that also contains a meter, controls, lancing device,and instructions for use.

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510(k) Summary, continued Ascensia Contour Blood Glucose Monitoring System (modified test strip) Page 2 of 2

Intended Use:	The Ascensia® CONTOUR® Blood Glucose MonitoringSystem (modified test strip) is used for the measurement ofglucose in whole blood. The Ascensia® Contour® BloodGlucose Monitoring System is an over-the-counter (OTC)device used by persons with diabetes and by healthcareprofessionals in home settings and in healthcare facilities.The Ascensia® CONTOUR® Blood Glucose MonitoringSystem is indicated for use with capillary, venous, andarterial whole blood samples. Capillary samples may bedrawn from the fingertip, palm, forearm, abdomen and thigh.
TechnologicalCharacteristics:	There were no changes to the fundamental scientifictechnology.
Comparison toPredicate device:	The modifications to the device encompass a designchange, a labeling change, and a material change. Therehas been no change to the intended use, operating principle,or functionality of the device.
Assessment ofPerformance:	An evaluation of the Ascensia® CONTOUR® Blood GlucoseMonitoring System (modified test strip) was studied in thelaboratory and in a clinical setting by persons with diabetes.The results were compared to results from the originalAscensia® CONTOUR® Blood Glucose Monitoring Systemand to a laboratory method. The studies showed equivalentperformance with the original Ascensia® CONTOUR® BloodGlucose Monitoring System.
Conclusion:	The results of the laboratory and clinical evaluations of theAscensia® CONTOUR® Blood Glucose Monitoring System(modified test strip) demonstrated that the device producesblood glucose results that are substantially equivalent toresults obtained on the predicate device. Therefore, thesystem with the modified strip is as safe and effective as the

original system. •

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 2 2006

Mr. Roger Sonnenburg Manager of Regulatory Affairs Bayer HealthCare, Diabetes Care Division 430 South Beiger Street Mishawaka, IN 46544

Re: K060470

Trade/Device Name: Ascensia® Contour® Blood Glucose Monitoring System (modified test strip) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: February 22, 2006 Received: February 23, 2006

Dear Mr. Sonnenburg:

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours.

Alberto Gutierrez

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060470

Device Name: Ascensia Contour® Blood Glucose Monitoring System (modified test strip)

Indications For Use: The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia ® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Prescription Use X (Part 21 CFR 801 Subpart D) ÁNDYOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Carol C. Benson
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k)

Page 1 of __

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.