CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System

K191286 · Ascensia Diabetes Care · NBW · Nov 8, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191286
• Device Name: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 8, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Contour Blood Glucose Monitoring Systems in this submission are intended for single-patient use only.

Device Story

The CONTOUR NEXT series are blood glucose monitoring systems (BGMS) used by patients for self-monitoring of blood glucose levels. The systems utilize test strips to measure glucose in capillary whole blood samples. The modification involves the introduction of individually wrapped test strips for use with existing, previously cleared CONTOUR NEXT meter platforms. The systems provide quantitative glucose readings to assist patients in managing diabetes. The devices are intended for single-patient use. The fundamental scientific technology, including the electrochemical measurement principle, remains unchanged from the predicate devices.

Clinical Evidence

No new clinical data was required for this modification. The submission relied on design control activities, risk analysis, and verification/validation of the modified test strip packaging to demonstrate substantial equivalence.

Technological Characteristics

The system utilizes electrochemical glucose measurement technology. The modification consists of individually wrapped test strips. The meters are designed for single-patient use and have been validated for 260 cleaning and 260 disinfection cycles using Clorox Germicidal Wipes (EPA #67619-12) to support a 5-year service life.

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 Blood Glucose Monitoring System (K160430)
• Contour Next USB Blood Glucose Monitoring System (K150942)
• Contour Next One Blood Glucose Monitoring System (K160682)
• Contour Next EZ Blood Glucose Monitoring System (K162336)
• Contour Next Link Wireless Blood Glucose Monitoring System (K160430)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K191286

B Applicant

Ascensia Diabetes Care

C Proprietary and Established Names

CONTOUR® NEXT Blood Glucose Monitoring System
CONTOUR® NEXT USB Blood Glucose Monitoring System
CONTOUR® NEXT ONE Blood Glucose Monitoring System
CONTOUR® NEXT EZ Blood Glucose Monitoring System
CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System

## D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Contour® Next Blood Glucose Monitoring System (K160430), Contour® Next USB Blood Glucose Monitoring System (k150942), Contour® Next One Blood Glucose Monitoring System (k160682), Contour® Next EZ Blood Glucose Monitoring System (k162336), and Contour® Next Link Wireless Blood Glucose Monitoring System (k160430).

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2. Submitter's statement that the INDICATIONS FOR USE/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).

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 addition of individually wrapped test strips to be used with each of the predicate blood glucose monitoring systems.

3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

4. 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 device.

The Contour Blood Glucose Monitoring Systems in this submission are intended for single-patient use only. Disinfection efficacy studies described for the predicate devices using Clorox® Germicidal Wipes (EPA registration # 67619-12) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meters. Studies described for the predicate devices also demonstrate that there was no change in performance or in the external materials of the meter after 260 cleaning and 260 disinfection cycles (520 cleanings total) designed to simulate cleaning and disinfection to support 5 years of single-patient use. 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 devices that would warrant new disinfection efficacy or robustness testing.

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