CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

K121087 · Bayer Healthcare · NBW · Jun 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121087
• Device Name: CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 28, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Contour® NEXT USB blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The Contour® NEXT USB blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The Contour® NEXT USB blood glucose monitoring system may be used as an aid to monitor the effectiveness of a diabetes control program and is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour® NEXT Test Strips are for use with the Contour® NEXT USB blood glucose monitoring system for the quantitative measurement of glucose in whole blood. The Contour® NEXT Controls are for use with the Contour® NEXT USB blood glucose monitoring system to check that the meter and test strips are working properly. Glucofacts® Deluxe Diabetes Management Software is an overthe-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

Handheld blood glucose meter; uses dry reagent test strips; capillary action draws blood into strip tip. Principle: FAD glucose dehydrogenase (FAD-GDH) enzyme reacts with glucose; electrons shuttled to electrode by mediator; electrical current proportional to glucose concentration measured. Used in home settings by patients; results displayed on meter. Glucofacts Deluxe software allows healthcare professionals and patients to view/print reports of blood sugar readings from meter data. System includes liquid controls for performance verification. Benefits include effective monitoring of diabetes control programs.

Clinical Evidence

Bench testing only. Sponsor performed risk analysis and verification/validation activities to confirm modifications did not impact device performance. Cleaning and disinfection protocol validated for 260 cycles (simulating 5 years of weekly use) using Clorox Germicidal Wipes (0.55% sodium hypochlorite) to ensure no degradation of materials or performance.

Technological Characteristics

Handheld meter; dry reagent test strips; FAD-GDH electrochemical sensing principle. Connectivity via USB. Software-based data management (Glucofacts Deluxe).

Indications for Use

Indicated for persons with diabetes (excluding neonates) for quantitative blood glucose measurement using fresh capillary whole blood from fingertip or palm. Used as an aid to monitor diabetes control programs.

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 NEXT LINK Wireless Glucose Monitoring System (K110894)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k121087

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

1. The name and 510(k) number of SUBMITTER'S previously cleared device: Bayer Contour NEXT LINK Wireless Glucose Monitoring System (k110894).

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. (labeling changes are permitted as long as they do not affect the intended use).

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 Contour NEXT USB Blood Glucose Monitoring System:

1) The elimination of the capability to wirelessly transmit glucose values to compatible Medtronic Minimed devices.

2) The inclusion of data management software (Glucofacts Deluxe, previously cleared under k091820).

3) Adding feature to allow data logging pertaining to carbohydrates and insulin.

4) Increased storage memory from 1000 to 2000 test results.

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.

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A new cleaning and disinfection protocol is not necessary for this modified device. The previous device (predicate) disinfection protocol states that "The device is intended for single-patient use only. Clorox® Germicidal Wipes containing 0.55% sodium hypochlorite with EPA registration # 67619-12 were validated demonstrating complete inactivation of live virus using materials from the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 260 cleaning and disinfection cycles designed to simulate cleaning and disinfection 1x per week for 5 years. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures."

The sponsor demonstrated that there was no change in performance or in the external materials of the modified device using the predicate disinfection procedure (after 260 cleaning and disinfection cycles).