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

K091820 · Bayer Healthcare · NBW · Aug 26, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091820
• Device Name: CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Contour USB Blood Glucose Monitoring System measures glucose in whole blood samples (capillary, venous, arterial). System includes blood glucose meter and Glucofacts Deluxe Diabetes Management Software. Meter accepts blood samples via test strips; performs electrochemical glucose measurement. Output displayed on meter screen; data transferred to PC via integrated USB connector. Software allows patients and healthcare professionals to view/print reports of blood sugar readings from Bayer Contour and Breeze meter families. Used in home and clinical settings to assist in diabetes management. Provides frequent monitoring data to support clinical decision-making and patient self-care.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation of device modifications.

Technological Characteristics

OLED display; rechargeable battery; USB interface for PC connectivity. Software resides in flash memory. Fundamental glucose sensing technology unchanged from predicate. Form factor modified for portability.

Indications for Use

Indicated for quantitative capillary whole blood glucose monitoring in patients with diabetes in home and clinical settings; aid for diabetes control monitoring. Contraindicated for neonatal use and diabetes diagnosis/screening.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Contour Blood Glucose Meter (K062058)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k091820

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System:

1. The name and 510(k) number of Bayer Healthcare's Previously Cleared Device, Contour Blood Glucose Meter, cleared under k062058. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the shape, size, rechargeable and OLED display were added. UI was modified. Indications for use are more restrictive by removing the heel stick and neonatal claim. The USB contains a feature (not utilized at this time) which allows for future uploading of new algorithms and data management software. Future uploads are not "critical updates". A database has been added that can be used when the software runs off a PC. In addition, data management software will reside in flash memory on the Contour USB meter and can launch directly from the meter itself by plugging the meter into the USB port of a PC.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.