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510(k) Data Aggregation

    K Number
    K090120
    Device Name
    REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Date Cleared
    2009-03-24

    (62 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061468,K982415
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    REFSTAR® PLUS with QWIKPATCH® External Reference Patch: The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.

    REFSTAR® PLUS Cable: The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.

    Device Description

    The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable. This submission focuses on establishing substantial equivalence to a predicate device, rather than a clinical study proving performance against acceptance criteria in the typical sense of AI/algorithm performance.

    Therefore, many of the requested categories are not applicable to this type of submission. However, I will extract the available information and indicate where information is not present.

    1. Table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Mechanical integrity (Implicit)Passed bench testing to validate mechanical integrity.
    Electrical integrity (Implicit)Passed bench testing to validate electrical integrity.
    Performance with CARTO® and NOGA® Systems (Implicit: "provide a reference point for catheter tip location")Passed bench testing to validate performance with CARTO® and NOGA® Systems.
    Substantial Equivalence to Predicate Device (Explicit requirement for 510(k) clearance)Found substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended use, operating principles, fundamental scientific technology, design and performance.

    2. Sample size used for the test set and the data provenance

    This section is not applicable. The submission describes "bench testing" for mechanical and electrical integrity and performance with systems. It does not refer to a test set of data derived from patients or human subjects. The provenance of any data used for bench testing is not specified.

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

    This section is not applicable. Ground truth for a clinical or AI performance study is not relevant here as it's a device safety and performance validation through bench testing, not a clinical trial or AI algorithm evaluation.

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

    This section is not applicable. There was no clinical test set requiring adjudication.

    5. 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

    This section is not applicable. This is not an AI device, and no MRMC study was conducted or referenced. The device provides a reference point for catheter tip location within existing navigation systems (CARTO® and NOGA®), rather than AI assistance to human readers.

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

    This section is not applicable. This device is an external reference patch and cable, not a standalone algorithm. Its function is to provide an input (reference point) to the CARTO® and NOGA® systems, which are themselves non-fluoroscopic navigation systems.

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

    This section is not applicable in the context of clinical "ground truth." The "ground truth" for the bench testing would have been established by engineering specifications, calibration standards, and expected performance parameters when integrated with the CARTO® and NOGA® systems.

    8. The sample size for the training set

    This section is not applicable. This is not an AI/machine learning device, so there is no concept of a training set.

    9. How the ground truth for the training set was established

    This section is not applicable, as there is no training set for this device.

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