CONTOUR NEXT BLOOD GLUCOSE METER

K121190 · Bayer Healthcare, LLC · LFR · Jul 26, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121190
• Device Name: CONTOUR NEXT BLOOD GLUCOSE METER
• Applicant: Bayer Healthcare, LLC
• Product Code: LFR · Clinical Chemistry
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device system is intended for single-patient use only.

Device Story

Handheld blood glucose meter; uses dry reagent test strips and liquid controls; measures glucose in capillary whole blood. Operated by persons with diabetes in home settings. Device performs electronics self-test before measurement; uses blood glucose measurement algorithm and automatic calibration. Output displayed on meter screen; informs patient of glucose levels for self-management. Differences from predicate include removal of wireless transmission to Medtronic devices, use of replaceable batteries, and physical form factor changes. Benefits include accurate, convenient home glucose monitoring.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety (IEC 61010-1:2001), cleaning/disinfection robustness, drop/spill testing, and summative usability study for initial setup and mock blood glucose testing.

Technological Characteristics

Handheld meter; dry reagent test strip sensing; replaceable battery power; data port for PC interface. Complies with IEC 61010-1:2001. Software-based electronics self-test and automatic calibration.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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 Blood 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 K121190

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):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k110894, Bayer CONTOUR NEXT Link Wireless Blood Glucose Monitoring System

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:
- removal of the wireless transmission capability
- Resized meter case and LCD display
- Change from four to three user meter operation buttons
- Change in button materials
- Addition of a 90-day selection to display test results and trends
- Change in memory capacity from 1000 to 800 test results
- Connectivity to a personal computer via a micro-USB port
- Change in power supply to two replaceable 3 volt lithium button batteries
- To make the test strip port not illuminated.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including:
- labeling, intended use, physical characteristics, user interface, detection technologies, reagents, automatic calibration, quality control, and the same blood glucose measurement algorithm.

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. FMEA
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.

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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.

The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes (EPA Registration # 67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter and lancing device after 260 cleanings and 260 disinfection cycles (total of 520 wipes). The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.