Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

K160430 · Ascensia Diabetes Care U.S., Inc. · NBW · Jun 24, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160430
• Device Name: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care U.S., Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 24, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Contour Next 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 is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The Contour Next 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 system consists of a Contour Next blood glucose meter. Contour Next control solutions. Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates. The Contour Next Link Wireless 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 singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The Contour Next Link Wireless 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). Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The Contour Next Link Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Device Story

Handheld blood glucose meters (Contour Next and Contour Next Link Wireless) measure glucose in capillary whole blood using dry reagent test strips; amperometric detection principle; FAD-glucose dehydrogenase (FAD-GDH) enzyme reaction generates current proportional to glucose concentration. Used by patients with diabetes in home settings. Contour Next Link Wireless model transmits results via RF to compatible Medtronic insulin pumps and facilitates data transfer to Carelink software. Meters provide quantitative glucose readings; include error detection for exposed test strips, un-mixed control solutions, and sample perturbation. Healthcare providers use results to monitor diabetes control effectiveness. Benefits include accurate self-monitoring and integrated data management for insulin pump users.

Clinical Evidence

Bench testing only. No clinical data presented. Verification activities focused on the performance of new error-detection algorithms for test strip degradation, control solution errors, and sample perturbation. Disinfection efficacy previously established via studies using 0.55% sodium hypochlorite wipes, demonstrating HBV inactivation and material robustness over 520 cycles.

Technological Characteristics

Electrochemical glucose sensing. Modified to include firmware-based error condition checks. Next Link Wireless model includes RF transmitter for insulin pump communication. Materials and physical form factor unchanged from predicates. Sterilization/disinfection validated for 520 cycles using 0.55% sodium hypochlorite.

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 Link Wireless Blood Glucose Monitoring System (K122370)
• Contour Next Blood Glucose Monitoring System (K121190)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K160430

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 Blood Glucose Meter and Contour Next Link Wireless Blood Glucose Meter.

1. The name and 510(k) numbers of the SUBMITTER'S previously cleared devices. (For a preamendments device, a statement to this effect has been provided.): CONTOUR NEXT BLOOD GLUCOSE METER (K121190) and CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (K122370). The two devices included in this submission are modified versions of the Contour Next Link Wireless Blood Glucose Meter device cleared in k110894. The fundamental technologies of these devices are the same, though the Next Link Wireless system includes a radio frequency (RF) function for sending blood glucose results to compatible Medtronic MiniMed insulin pumps. The modifications in this special 510(k) were made to both devices.

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 addition of mechanisms to detect errors that might occur during use of the device. Specifically, the device was modified to include 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 devices be determined substantially equivalent to the previously cleared (or their preamendment) devices.

The Contour Next Blood Glucose Meter is intended for single-patient use only. Disinfection efficacy studies described for the predicate devices (k121190 for Contour Next Blood Glucose Meter) 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 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 1x per week for 5 years. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. There were no physical

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changes to the device relative to the predicate that would warrant new disinfection efficacy or robustness testing.