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510(k) Data Aggregation

    K Number
    K992406
    Device Name
    VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    1999-08-06

    (17 days)

    Product Code
    GEI,K97
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K974022,K963783
    Why did this record match?
    Device Name :

    VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM

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

    The Mitek VAPR™ System, when used with a VAPR™ 2.3mm End Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

    Device Description

    The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study information for the VAPR™ 2.3mm End Effect Electrode.

    Note: The provided document is a 510(k) summary for a Special 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device for a device modification. This type of submission typically does not contain detailed performance studies with acceptance criteria, ground truth, expert reviews, or MRMC studies in the same way a de novo or PMA submission for a novel AI/software device would. The performance assessment here is primarily framed around the established safety and performance of the predicate device and the validation of the modification.

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceComments
    Safety and Performance (General): Device modification maintains the safety and performance characteristics of the predicate device."Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."The document states that validation testing was conducted for the device modification to demonstrate continued safety and performance. Specific quantifiable performance metrics or acceptance thresholds are not detailed in this summary, as is typical for a Special 510(k) where the primary argument is substantial equivalence to a pre-existing, approved device. The "results of validation testing" are not explicitly presented.
    Substantial Equivalence to Predicate Device"Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VAPT™ 2.3mm End Effect Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act."This is the overarching "acceptance criterion" for a 510(k) submission. The performance is deemed acceptable because it is demonstrably similar to a device already deemed safe and effective.
    Indications for Use (Unchanged)"The Mitek VAPR™ System, when used with a VAPR™ 2.3mm End Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist."The indications for use are identical to those of the predicate and are maintained with the modified device.

    Study Details (as inferable from the document)

    Given the nature of this 510(k) submission (a Special 510(k) for a device modification), the detailed "study" as one might expect for a novel AI/software device is not present in the public summary. The "study" mentioned here refers to the internal validation and verification processes conducted by the manufacturer to ensure the modified device still meets its design requirements and is substantially equivalent to the predicate.

    1. Sample Size Used for the Test Set and Data Provenance:

      • Sample Size: Not specified in the provided summary. Validation testing would involve a certain number of test units or trials, but these specifics are not public in this type of document.
      • Data Provenance: Not specified. This would be internal Mitek testing.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

      • Number of Experts/Qualifications: Not applicable for this type of submission focused on hardware modification and substantial equivalence. "Ground truth" in the context of device performance refers to objective physical measurements or functional assessments, not human expert interpretation of data.

    3. Adjudication Method for the Test Set:

      • Adjudication Method: Not applicable. Performance testing for an electrosurgical electrode would typically involve engineering tests, bench testing, and potentially animal or cadaver studies, not expert adjudication in the manner of diagnostic image interpretation.

    4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

      • MRMC Study: No. This type of study is for diagnostic devices where human readers interpret data, often with and without AI assistance. This device is an electrosurgical electrode, not a diagnostic AI system.

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

      • Standalone Performance: Not applicable. This device is hardware (an electrosurgical electrode) that inherently requires a human operator for its intended use. There is no "algorithm only" performance to speak of.

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

      • Type of Ground Truth: For an electrosurgical electrode, ground truth would relate to measurable physical parameters (e.g., tissue temperature, ablation depth, cutting speed, hemostasis efficacy) and functional performance criteria verified through bench testing, pre-clinical (animal/cadaver) studies, and potentially clinical observation (though clinical data is not explicitly mentioned as being generated for this specific 510k). The summary mentions "validation testing" and "performance testing," which implies objective, measurable outcomes rather than subjective expert consensus.

    7. The sample size for the training set:

      • Sample Size: Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

      • Ground Truth Establishment for Training Set: Not applicable, as there is no training set for a hardware device.
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