CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM by BAYER HEALTHCARE

The Contour USB Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Contour USB is an over the counter (OTC) device utilized by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Contour USB Diabetes Care System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from fingertip, palm and forearm. The Contour USB is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

GLUCOFACTS® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by Health Care Professionals and Patients with Diabetes for viewing and printing reports that display blood sugar readings from Bayer's CONTOUR® and BREEZE® families of meters.

Device Description

Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System

AI/ML Overview

This FDA 510(k) clearance letter for the Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System (K091820) primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The document confirms the device's legality for marketing and mentions its intended use for measuring glucose in whole blood for individuals with diabetes and healthcare professionals. However, it does not provide any specific performance data, study results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement details.

To provide a comprehensive answer, I would need access to the actual 510(k) submission (which often includes performance data and studies) or other publicly available documentation from the manufacturer or FDA related to this specific device.

Based only on the provided document, here's what can be inferred or explicitly stated, with significant limitations:

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

Not available in the provided document. The document is a clearance letter, not a performance report. Performance data and acceptance criteria would be part of the original 510(k) submission, not typically summarized in the clearance letter itself.

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

Not available in the provided document.

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 available in the provided document. For a blood glucose meter, the "ground truth" is typically established by laboratory reference methods, not necessarily by expert consensus in the same way as imaging interpretation.

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

Not applicable/Not available in the provided document. Adjudication methods like 2+1 or 3+1 are common in image interpretation studies where experts disagree. For quantitative measurements like blood glucose, agreement is typically assessed against a reference method rather than through expert adjudication of results.

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/Not available in the provided document. MRMC studies are relevant for diagnostic imaging interpretation where human readers interpret cases. This device is a blood glucose meter, where the user reads a numerical output, not a complex image. The "AI" component mentioned (Glucofacts Delux software) is for viewing and printing reports, not for performing interpretative diagnostics and thus an MRMC study in the traditional sense wouldn't apply to the meter's performance.

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

Yes, implicitly for the blood glucose meter itself. The Contour USB Blood Glucose Meter is expected to operate as a standalone device, providing a numerical glucose reading without human interpretation of raw signals. Its performance would be assessed standalone against a reference method. The document, however, does not provide performance data.

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

Likely a laboratory reference method. For blood glucose meters, the ground truth is almost universally established by comparing the device's readings to laboratory-based reference methods (e.g., YSI glucose analyzer) on the same blood samples. This is a highly accurate chemical analysis, not expert consensus or pathology in the typical sense.
Not explicitly stated in the provided document.

8. The sample size for the training set

Not applicable/Not available in the provided document. For a traditional medical device like a blood glucose meter, the "training set" concept (as used for machine learning models) does not directly apply. The device is calibrated and validated, but it doesn't "learn" from a training set in the same way an AI algorithm does.

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

Not applicable/Not available in the provided document. (See point 8)

In summary, the provided FDA clearance letter is insufficient to extract the detailed study and acceptance criteria information you are requesting. Answering these questions fully would require accessing the original 510(k) submission data.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

AUG 2 6 2009

Bayer Healthcare c/o Marc Henn 430 South Beiger Street Mishawaka, IN 46544

Re: K091820

Trade/Device Name: Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, LFR, JQP Dated: July 24, 2009 Received: July 29, 2009

Dear; Mr. Henn:

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. Iisting 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H

Courtney C. Harper, Ph.D. Acting 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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Indication for Use

510(k) Number (if known):

K091820

Device Name: Contour USB, Glucofacts® DELUXE Diabetes Management Software

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Affice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091820

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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.