(69 days)
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No
The document describes a standard blood glucose monitoring system and data management software without mentioning any AI or ML capabilities.
No
The device measures glucose levels but does not provide therapy or treatment for diabetes; it is used for monitoring purposes.
No
The "Intended Use / Indications for Use" section explicitly states, "The Contour USB is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly lists "Contour USB Blood Glucose Meter, Glucose Test Strips" as components, indicating it includes hardware in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the "measurement of glucose in whole blood." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (whole blood) outside of the body to provide information about a person's health status (blood glucose levels).
- Sample Type: It explicitly states it uses "whole blood samples" (capillary, venous, and arterial). This confirms it's analyzing a biological specimen.
- Purpose: The purpose is to "monitor blood glucose," which is a key aspect of managing diabetes. This monitoring provides diagnostic information about the patient's condition.
While the software component (GLUCOFACTS® Deluxe) is also mentioned, the core device, the Contour USB Blood Glucose Monitoring System, fits the definition of an IVD. The software is a tool for managing the data generated by the IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW, LFR, JQP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertip, palm and forearm
Indicated Patient Age Range
not intended for use on neonates
Intended User / Care Setting
persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
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):
Device Name: Contour USB, Glucofacts® DELUXE Diabetes Management Software
Indication For Use:
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.
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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