(179 days)
The CONTOUR® NEXT EZ Blood Glucose Monitoring System is an over the counter (OTC) device utilized for selftesting by persons with diabetes at home for the quantitative measurement of glucose in whole blood, 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 EZ Blood Glucose Monitoring System is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EX EZ 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 EZ blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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 test strips and 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 its 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 be used 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.
The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The CONTOUR® NEXT ONE Blood Glucose Monitoring System should be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood draw from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
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 singlepatient 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.
The CONTOUR® NEXT Blood Glucose Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. The strips remain the same; and the only change is the new alternative packaging.
The modification discussed in this Special 510K consists a new, alternative packaging configuration of a desiccated-lined foil pouch, with each pouch containing five individually sealed, test strips in comparison to the existing blood glucose test strips in a desiccated-lined bottle.
The CONTOUR® NEXT Blood Glucose Test Strips are for use with the following CONTOUR® NEXT Blood Glucose Monitoring Systems:
CONTOUR® NEXT
CONTOUR® NEXT USB
CONTOUR® NEXT ONE
CONTOUR® NEXT EZ
CONTOUR® NEXT LINK Wireless
This document describes the FDA's 510(k) clearance for several CONTOUR® NEXT Blood Glucose Monitoring Systems, specifically focusing on a change to the packaging of the test strips. The core of the submission is to demonstrate that the new packaging, a desiccated-lined foil pouch containing five individually sealed test strips, performs equivalently to the existing desiccated-lined bottle packaging.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria defined by specific performance metrics for glucose measurement accuracy (e.g., ISO 15197:2013 standards for accuracy, precision). Instead, it states:
"Verification and validation testing against well-established methods showed that the CONTOUR® NEXT test Strips with the proposed, alternative foiled packaging, performed as intended and met the system specifications."
This implies that the acceptance criteria are the "system specifications" and "well-established methods" for glucose measurement devices. The reported device performance is that the new packaging met these specifications. However, no specific numerical data or thresholds are provided in this summary.
Given the nature of the device (blood glucose monitoring system) and the regulatory context (FDA 510(k) summary), the implicit acceptance criteria would relate to the accuracy, precision, and clinical usability of the blood glucose measurements compared to a reference method, typically governed by standards like ISO 15197. The document asserts that these were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing (the "test set") or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "Verification and validation testing."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth, as this type of device (blood glucose meter) typically uses laboratory reference methods for ground truth, not expert human interpretation of images.
4. Adjudication Method for the Test Set
The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies involving human readers or interpretation of complex data (like medical images) where there can be disagreement among experts. For a blood glucose monitoring system, the ground truth is established through a laboratory reference method, so no adjudication method as described would be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for imaging devices or AI tools that assist human interpretation. Since this device is a blood glucose meter, which provides a quantitative measurement, an MRMC study is not applicable or described. The device does not assist human readers in diagnosing or interpreting images, but rather provides a direct numerical measurement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This device is an in-vitro diagnostic device that provides a direct measurement, not an AI algorithm for interpretation. Therefore, the concept of "standalone performance" in the context of an algorithm without human-in-the-loop is not applicable. The device itself is the "standalone" measurement system.
7. Type of Ground Truth Used
While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth for performance evaluation is typically established using a laboratory reference method (e.g., a YSI STAT 2300 Glucose & Lactate Analyzer or similar highly accurate laboratory instrument) that measures glucose concentration in blood samples. This provides a gold standard against which the device's measurements are compared. The phrase "well-established methods" strongly implies the use of such a reference standard.
8. Sample Size for the Training Set
This document describes a 510(k) submission for a change in packaging for an existing device. It does not indicate that this submission involves a "training set" in the context of machine learning. Blood glucose meters are electrochemical or optical devices, not machine learning algorithms that require training data. Therefore, the concept of a "training set" as it pertains to AI/ML is not applicable here.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the context of AI/ML for this device, this question is not applicable.
Summary of what the document implies about the study:
The document indicates that the study performed was a verification and validation of the new packaging's effect on the performance of the existing CONTOUR® NEXT test strips. The key finding is that the test strips in the new foil pouch packaging deliver performance that "met the system specifications" when tested against "well-established methods" (likely laboratory reference methods). Additionally, "Usability testing was conducted on the proposed foiled packaging to ensure that the packaging was easy to use and labeling understood by typical customers." This suggests that the study primarily focused on ensuring the new packaging did not negatively impact the established analytical performance of the test trips, and that it was still user-friendly.
§ 862.1345 Glucose test system.
(a)
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.(b)
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.