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510(k) Data Aggregation

    K Number
    K123353
    Device Name
    CIQ CONTROLLER, CIQ WANDS
    Manufacturer
    ARTHROCARE CORPORATION
    Date Cleared
    2013-04-05

    (156 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K070374,K063538,K033257,K014290,K091674
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

    • Adenoidectomy
    • Head, Neck, Oral, and Sinus Surgery
    • Myringotomy with Effective Hemorrhage Control
    • Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
    • Papilloma Keloids
    • Submucosal Tissue Shrinkage
    • Traditional Uvulopalatoplasty (RAUP)
    • Tissue in the Uvula/Soft Palate for the treatment of Snoring
    • Cysts
    • Mastoidectomy
    • Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
    • Neck Mass
    • Submucosal Palatal Shrinkage
    • Tonsillectomy (including palatine tonsils)
    • Tumors
    Device Description

    The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ ENT Plasma Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).

    The CIQ Wands are bipolar, single use, radiofrequency-based electrosurgical devices designed for use with the CIQ Controller for specific indications in otorhinolaryngology (ENT) procedures.

    The CIQ Controller is a bipolar, high frequency electrosurgical generator with an integrated peristaltic pump for saline delivery.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the ArthroCare® Coblator IQTM ENT System, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria/OutcomeReported Device Performance
    Bench TestingEvaluate the performance of the Coblator IQ ENT System compared to predicate devices."The test results demonstrate that the Coblator IQ ENT System meets all design and performance specifications."
    Animal TestingCompare the tissue effects using the Coblator IQ ENT System as compared to predicate devices."Based on the test results, the proposed devices are substantially equivalent to the predicate devices."
    Clinical Testing(Not applicable for this submission)"No clinical data are included in this submission."
    Substantial EquivalenceDemonstrated equivalence to predicate devices (ArthroCare ENT Plasma Wands & ArthroCare Coblator IQ System (Controller)) in terms of safety and effectiveness, despite minor changes in performance specifications, materials, labeling, and minor software changes to the controller. The changes should not affect the safety or efficacy of the devices."The modified CIQ Wands are substantially equivalent to the predicate ArthroCare ENT Plasma Wands. The modification to performance specifications, materials, and labeling are minor changes, and do not affect the safety or efficacy of the devices. ... However, these changes do not affect the safety or efficacy of the device."

    Study Details:

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

      • Bench Testing: The specific number of devices or tests conducted for bench testing is not explicitly stated. The data provenance is internal to the manufacturer (ArthroCare Corporation).
      • Animal Testing: The specific number of animals or studies is not explicitly stated. The data provenance is internal to the manufacturer (ArthroCare Corporation).
      • Clinical Testing: No clinical test set was used, as "No clinical data are included in this submission."

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

      • Not applicable/Not specified. The studies conducted (bench and animal) for substantial equivalence typically rely on predefined specifications and direct observational/measurement comparisons, not expert human interpretation for ground truth.

    3. Adjudication Method for the Test Set:

      • Not applicable/Not specified. Given the nature of the bench and animal testing described (comparison to predicate devices and specifications), an adjudication method relying on multiple human reviewers is not relevant.

    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 study was done. This device is an electrosurgical system, not an AI-powered diagnostic or assistive tool for human readers.

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

      • Not applicable. This device is a surgical instrument system, not an algorithm. Its performance is evaluated through its physical and functional characteristics.

    6. The Type of Ground Truth Used:

      • Bench Testing: Engineering specifications and performance metrics derived from predicate devices or established industry standards.
      • Animal Testing: Macroscopic and microscopic tissue effects, likely evaluated against established biological responses or direct comparison to predicate device effects.

    7. The Sample Size for the Training Set:

      • Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device's design and operation would implicitly come from the extensive history and development of similar electrosurgical technologies and predicate devices.

    8. How the Ground Truth for the Training Set was Established:

      • Not applicable, as no training set was explicitly used in the context of AI/ML. The device's "ground truth" for design and manufacturing would be based on established engineering principles, material science, and regulatory requirements for medical devices.
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