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510(k) Data Aggregation

    K Number
    K110894
    Device Name
    CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
    Manufacturer
    BAYER HEALTHCARE
    Date Cleared
    2012-03-28

    (364 days)

    Product Code
    LFR,JJX,NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K091820,K073231,K070438
    Predicate For
    K121087,K121190,K122370
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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. The system consists of a Contour NEXT LINK Wireless 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 from 20 to 600 mg/dL.

    The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in selftesting by people with diabetes as a quality control check.

    The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit dlucose values to Medtronic MiniMed Paradigm Insulin pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME Monitor 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 Description

    The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System is intended to transmit blood glucose results to compatible Medtronic Minimed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic Minimed insulin pumps to Medtronic's Minimed PC based data management software.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Contour® NEXT LINK Wireless Blood Glucose Meter, extracted from the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Precision (Repeatability - ISO 15197 Section 7.2.2): Internal acceptance criteria are Cpk > 0.65 at all levels.Pass: All Cpk's greater than 0.65.
    Precision (Intermediate Precision - ISO 15197 Section 7.2.3): Internal acceptance criteria are Cp > 1.0 at all levels.Pass: All Cp’s above 1.0.
    Accuracy (System Accuracy - ISO 15197 Section 7.3): 95% of results within ±15 mg/dL for glucose < 75 mg/dL, and 95% of results within ±20% for glucose ≥ 75 mg/dL.Pass for Contour NEXT reagent strips.- YSI Glucose < 75 mg/dL: 100% (51 of 51) within ±15 mg/dL.- YSI Glucose ≥ 75 mg/dL: 100% (249 of 249) within ±20%.
    Linearity/Assay Reportable Range: Cpk ≥ 0.65 at all levels.Pass: Values measured across the intended glucose measuring range.
    Detection Limit (Extreme Glucose Levels): For blood with extreme glucose levels, the meter must display "Low" or "High" glucose error messages.Pass: All extremely low and extremely high samples generated "Low" or "High" error messages as appropriate.
    Analytical Specificity (Hematocrit): Mean difference from YSI reference values < 10 mg/dL or 10%.Pass: At all Hct levels, the mean difference from the reference values met the acceptance criterion.
    Analytical Specificity (Interfering Substances): Interfering substances should not have a significant effect on performance (except where noted, like ascorbic acid above 10 mg/dL causing +10% assay bias).Pass: Interfering substances, except for ascorbic acid, did not have a significant effect. Ascorbic acid above 10 mg/dL can cause a +10% assay bias, but therapeutic range is lower.
    RF Communication (BGM result to insulin pump): Medtronic pumps successfully receive values at 4 feet in 8 orientations; corrupted data recognized and not processed. Meter transmits BG values to receiving device at 4 feet at 916.5 MHz every 5 seconds for up to 12 attempts. Meter stops transmitting after receiving ACK or after 60 seconds without ACK. RF transmit feature can be turned On/Off. Meter has a 6-digit ID.Pass: EMC testing confirmed no incorrect value was accepted or displayed by the pump per RF and product specifications.
    Pass-through function (RF of pump data through BGM to PC): Meter, when connected to PC USB, enables communication between compatible Medtronic MiniMed device and PC for data/settings download to Medtronic data management software.Pass: Data transfer and pass-through mode testing demonstrated successful operation.
    Clinical Performance: 95% of results within ±20% (≥ 75 mg/dL) or within ±15 mg/dL (<75 mg/dL) of YSI results (for Contour NEXT LINK wireless meter using Contour NEXT reagent strips).Pass.- Fingerstick: 100% (110 of 110) within ±15 mg/dL or 20%.- AST Palm: 97.3% (106 of 109) within ±15 mg/dL or 20%.

    Study Information

    1. Sample size used for the test set and the data provenance:

      • Precision (Repeatability): Not explicitly stated as a "test set" in the context of patients, but involved 3 lots of Contour Next reagent strips and 10 Contour NEXT LINK wireless meters.
      • Precision (Intermediate Precision): 3 levels of Contour NEXT control, 3 Contour NEXT strip lots, 10 Contour NEXT LINK wireless meters over 10 days.
      • Accuracy (System Accuracy): 100 fresh capillary blood specimens. Data provenance is "Mishawaka site," implying an internal, likely prospective study.
      • Linearity/Assay Reportable Range: Not explicitly stated as a patient "test set." Involved 3 lots of Contour Next reagent strips, 8 aliquots of venous blood pool, 24 replicates on eight meters for linearity. For low-end cutoff, blood adjusted to 15 mg/dL.
      • Detection Limit: For low analytical range, 24 replicates on eight breadboard meters with glycolyzed 42% Hct whole blood samples at ~10, 15, and 20 mg/dL glucose. For extreme low/high, 8 meters tested with 72 reagent strips at 5 mg/dL, and 288 reagent strips at 900 mg/dL and above.
      • Analytical Specificity (Hematocrit): Unspecified number of blood samples evaluated at 15, 20, 30, 42, 55, 65% Hct across various glucose concentrations, with 3 reagent strip lots on 5 Contour NEXT LINK wireless meters in triplicate. High altitude simulation used 2 reagent strip lots on 5 meters in duplicate.
      • Analytical Specificity (Interfering Substances): Various substances tested, but no specific sample size for a "test set" is provided.
      • RF Communication: N of 30 meter and pump pairs.
      • Pass-through function: Not explicitly stated with a numerical sample size.
      • Clinical Performance (Fingerstick): 110 adults (aged 19-86). Data provenance is a "clinical trial" which is typically prospective.
      • Clinical Performance (AST Palm): 109 subjects. Data provenance is a "clinical trial" which is typically prospective.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not specified. For accuracy and clinical performance studies, the ground truth was established by a YSI™ glucose analyzer (Yellow Springs Instruments Stat Plus 2300 analyzer). The YSI is traceable to the hexokinase method, which is a recognized reference method. This is a laboratory instrument, not human experts.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable as the ground truth was established by a reference laboratory instrument (YSI glucose analyzer), not by human interpretation or consensus.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No MRMC comparative effectiveness study was done. This device is a blood glucose meter, and its performance is evaluated against a reference standard (YSI glucose analyzer), not against human reader interpretations. There is no AI component mentioned in the context of human assistance.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • Yes, the performance of the device itself (the blood glucose meter system) was evaluated in standalone mode against the YSI reference method for accuracy and clinical performance. The results reported in the tables reflect the algorithm's performance.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth for glucose measurements (Accuracy and Clinical Performance) was established by the YSI™ glucose analyzer, which is a laboratory reference method. For other technical aspects like detection limits and RF communication, ground truth or acceptance was based on predefined technical specifications and error messages.

    7. The sample size for the training set:

      • The document describes performance testing and clinical trials directly. It does not provide information about a separate "training set" in the context of machine learning. The studies described are for validation of the device's performance.

    8. How the ground truth for the training set was established:

      • Not applicable, as a machine learning "training set" is not mentioned or described in the provided regulatory summary.
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