CONTOUR® NEXT GEN Blood Glucose Monitoring System

K223293 · Ascensia Diabetes Care U.S., Inc. · NBW · Nov 18, 2022 · Clinical Chemistry

Device Facts

• Record ID: K223293
• Device Name: CONTOUR® NEXT GEN Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care U.S., Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Contour next GEN Blood Glucose Monitoring Systems is for single-patient use only.

Device Story

Blood glucose monitoring system; measures glucose levels in capillary whole blood; intended for single-patient use. System comprises meter and test strips. Modifications include updated user guide format (color booklet to B&W pamphlet), revised packaging configurations, and replacement/addition of equivalent meter circuit board components. Device operation remains unchanged from predicate. Used by patients for self-monitoring of blood glucose; provides quantitative results to assist in diabetes management. Meter materials validated for robustness and disinfection efficacy against Hepatitis B Virus (HBV) using Clorox Healthcare Bleach Germicidal Wipes.

Clinical Evidence

No new clinical data provided. Bench testing included disinfection efficacy studies (Clorox Healthcare Bleach Germicidal Wipes, EPA #67619-12) demonstrating complete inactivation of Hepatitis B Virus (HBV) and robustness studies simulating 5 years of use (260 cleaning/disinfection cycles) with no performance degradation.

Technological Characteristics

Blood glucose monitoring system; electrochemical sensing principle. Modifications involve circuit board component substitution with equivalent specifications. Meter materials validated for 260 cleaning/disinfection cycles. System is for single-patient use.

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 GEN Blood Glucose Monitoring System (K193407)

Submission Summary (Full Text)

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SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

I Background Information:

A 510(k) Number
K223293

B Applicant
Ascensia Diabetes Care US Inc.

C Proprietary and Established Names
CONTOUR® next GEN 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 GEN Blood Glucose Monitoring System (K193407).
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).
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:

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

K223293 - Page 1 of 2

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- Changed the User Guide from a color booklet format to a black and white pamphlet format in addition to minor formatting labeling changes to the user guide, quick reference guide and test strip insert.
- Modifications to the system component packaging configurations.
- Replacement or addition of alternative meter circuit board components with the same or equivalent specifications.

4. Comparison Information (i.e., similarities and differences) to the submitter'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.

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 GEN Blood Glucose Monitoring Systems is for single-patient use only. Disinfection efficacy studies described for the predicate device using Clorox Healthcare Bleach Germicidal Wipes (EPA #67619-12) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meters. Robustness 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 to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
K223293 - Page 2 of 2