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510(k) Data Aggregation

    K Number
    K063844
    Device Name
    REPROCESSED HEART STABILIZERS AND POSITIONERS
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2007-03-15

    (79 days)

    Product Code
    NQG,NOG
    Regulation Number
    870.4500
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K964445
    Why did this record match?
    Reference Devices :

    K964445

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

    Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

    Device Description

    Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction.

    Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.

    AI/ML Overview

    This submission is for reprocessed heart stabilizers and positioners, and the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full study with acceptance criteria and detailed performance data like a clinical trial for a novel device.

    Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory document. The focus here is on functional and safety testing to show the reprocessed device performs as intended and is equivalent to the original.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Functional Equivalence: Device must perform its intended function (stabilize, move, lift, and position the heart) as effectively as the predicate device."Representative samples of reprocessed heart stabilizers and positioners underwent functional testing to demonstrate appropriate functional characteristics." (No specific metrics or quantitative results provided)
    Cleaning Procedures Validation: Reprocessing must effectively clean the devices."Process validation testing was done to validate the cleaning... procedures." (No specific metrics or validation methods detailed)
    Sterilization Procedures Validation: Reprocessing must effectively sterilize the devices."Process validation testing was done to validate the... sterilization procedures." (No specific metrics or validation methods detailed)
    Packaging Validation: Reprocessing must ensure proper packaging for sterility and integrity."Process validation testing was done to validate the... device packaging." (No specific metrics or validation methods detailed)
    Visual and Functional Inspection: All reprocessed products must pass visual and functional checks."In addition, the manufacturing process includes visual and functional testing of all products produced." (No specific failure rates or inspection criteria provided)
    Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, indications for use, and methods of construction."The reprocessed heart stabilizers and positioners are substantially equivalent to the Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445)... This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction."

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

    • Test Set Sample Size: Not explicitly stated. The document mentions "representative samples" for functional testing and "all products produced" for manufacturing process testing, but no specific number of devices or tests.
    • Data Provenance: Not specified, but generally, such testing would be conducted internally by SterilMed, Inc. It is retrospective in the sense that it's testing on devices that have undergone reprocessing.

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

    • This is not applicable to a 510(k) for a reprocessed medical device. The "ground truth" here is the original device's performance characteristics, and the reprocessing is validated against maintaining those characteristics, not against expert interpretation of data.

    4. Adjudication Method for the Test Set

    • Not applicable. This is not a study involving human readers or expert adjudication of ambiguous cases.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for AI-assisted diagnostic devices, which is not the nature of this reprocessed instrument.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

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

    7. The Type of Ground Truth Used

    • The "ground truth" used for this submission is the performance specifications and characteristics of the original, new Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445). The reprocessing process and the reprocessed devices are validated to ensure they meet these established specifications, effectively performing identically to the new device.

    8. The Sample Size for the Training Set

    • Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

    • Not applicable, as there is no training set.
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