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510(k) Data Aggregation

    K Number
    K984435
    Device Name
    MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
    Manufacturer
    MEDTRONIC VASCULAR
    Date Cleared
    1999-01-07

    (27 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K960356,K923367,K980534,K905175
    Why did this record match?
    Reference Devices :

    K960356, K923367, K980534

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.

    Device Description

    The Medtronic KHONSARI Annuloplasty Band [Model H609M] is an implantable, flexible, adjustable band. The band reduces and stabilizes the mitral valve annulus in patients undergoing mitral valve repair. The body of the band is made of braided polyester and has drawstrings that permit segments of the annulus to be independently shortened.

    The band contains a flexible (non-metallic) radiopaque marker that enables radiographic visualization of its entire length. Eight radially spaced surgeon's flags indicate recommended locations for implantation sutures. Each annuloplasty band is attached to a holder. A circumferential groove in the holder protects the drawstrings from entrapment by the implanting sutures. The stem of the handle is malleable to facilitate seating of the band during placement.

    The four adjustable drawstrings are coiled within cylindrical canisters on the holder. A retaining suture secures each end of the band to the holder. The drawstrings will automatically release from the holder as it is removed from the band.

    AI/ML Overview

    The provided document is a 510(k) summary for the Medtronic KHONSARI™ Annuloplasty Band. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or most of the particular points requested in the prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types).

    The document focuses on demonstrating substantial equivalence to a previously cleared device (Medtronic SCULPTOR® Annuloplasty Ring) based on similar materials, manufacturing processes, intended use, and existing performance data from the predicate device.

    Here's an attempt to answer the questions based only on the provided text, with many fields necessarily left blank or marked as "Not provided in the document."

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Explicitly stated)Reported Device Performance (as per the document)
    Manufacturing Process Validation: Meet all procedure requirements."The modified manufacturing processes meet all procedure requirements."
    Physical Performance: Device performs as intended after routine sterilization and accelerated aging cycles."Physical performance studies were conducted to verify that the device performs as intended after routine sterilization and accelerated aging cycles."
    Sterilization Validation: Sterility assurance level (SAL) of 10^-6 at a minimum sterilization dose of 25kGy."Based on the results of the study, the sterility assurance level (SAL) of the sterilization process was qualified at 10^-6 sterilization level at a minimum sterilization dose of 25kGy."
    Biocompatibility: No changes to warrant new or additional testing."No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of the device components."
    Intended Use/Performance (General): Modifications do not affect intended use or performance."The verification/validation studies demonstrate that the modifications to the manufacturing process are appropriate and do not affect the intended use of the product."

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: Not provided in the document. The studies mentioned are described generally (e.g., "Physical performance studies," "Sterilization validation"), but no specific sample sizes for these tests are reported.
    • Data Provenance: Not applicable/Not provided. The "studies" described are engineering and manufacturing validation tests, not clinical studies with patient data from a specific country or with a retrospective/prospective design.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Not applicable/Not provided. The "test set" in this context refers to validation tests of the device's physical properties and manufacturing processes, not a dataset requiring expert interpretation for ground truth.

    4. Adjudication Method for the Test Set

    • Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints, which is not the type of study described here.

    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

    • Not applicable. This device is a medical implant (annuloplasty band) and not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study involving AI assistance for human readers would have been conducted or reported for this type of submission.

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

    • Not applicable. This is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    • For the engineering and manufacturing validation described: The "ground truth" would be established engineering specifications, established sterilization standards, and material property measurements. The document states that the processes "meet all procedure requirements" and the device "performs as intended."

    8. The Sample Size for the Training Set

    • Not applicable/Not provided. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The manufacturing process validation and performance studies are not described as involving a training set.

    9. How the Ground Truth for the Training Set was Established

    • Not applicable/Not provided. As there is no training set (as per question 8), this question is not relevant.
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