Contour Next USB Blood Glucose Monitoring System

K150942 · Bayer Healthcare · NBW · Nov 25, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150942
• Device Name: Contour Next USB Blood Glucose Monitoring System
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 25, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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 system consists of a Contour Next USB blood glucose meter, Contour Next test strips and Contour Next control solutions. 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. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The Contour Next USB blood glucose monitoring system 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.

Device Story

Handheld blood glucose meter for home use by patients with diabetes; utilizes dry reagent test strips with FAD glucose dehydrogenase (FAD-GDH) enzyme. Capillary blood sample drawn into strip via capillary action; glucose reaction generates electrons shuttled to electrode by mediator; resulting current proportional to glucose concentration. Meter calculates and displays glucose level. Modified device adds error detection for test strips exposed to reducing agents, un-mixed control solutions, and sample perturbation during countdown. Output displayed on OLED screen; results stored in memory; data transferable via USB. Benefits include improved accuracy through error detection, preventing biased results from compromised samples or strips. Operated by patient; healthcare providers review stored data to inform clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of software modifications. Disinfection efficacy previously established for predicate device (K121087) using 0.55% sodium hypochlorite wipes, demonstrating HBV inactivation and material robustness over 260 cycles.

Technological Characteristics

Electrochemical glucose monitoring system. Modification adds software-based error detection logic. Device materials and physical form factor unchanged from predicate. Connectivity via USB. Sterilization/disinfection validated for 0.55% sodium hypochlorite wipes.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of 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 USB Blood Glucose Monitoring System (K121087)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K150942

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): Contour Next USB Blood Glucose Monitoring System.

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.): Contour Next USB Blood Glucose Monitoring System (K121087).
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 addition of mechanisms to detect errors that might occur during use of the device. Specifically, the change includes the addition of error condition checks related to test strip degradation, improperly mixed control solutions, and sample perturbation during a test.

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

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 Contour Next USB Blood Glucose Monitoring System is intended for single-patient use only. Disinfection efficacy studies described for the predicate device (k121087, Contour Next USB Blood Glucose Monitoring System) using Clorox® Germicidal Wipes containing 0.55% sodium hypochlorite (EPA registration # 67619-12) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meter. Studies described for the predicate device also demonstrate that there was no change in performance or in the external materials of the meter 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. There were no physical changes to the device relative to the predicate that would warrant new disinfection efficacy or robustness testing.