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510(k) Data Aggregation

    K Number
    K955721
    Device Name
    CUFFED OROPHARYNGEAL AIRWAY (COPA)
    Manufacturer
    MALLINCKRODT MEDICAL
    Date Cleared
    1997-03-28

    (466 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a medical device, the COPA™ (Cuffed Oropharyngeal Airway), and a series of studies evaluating its performance. The text discusses preliminary feasibility studies, design modifications, functional (bench) testing, and several clinical studies.

    It's important to note that this document is a summary and lacks specific acceptance criteria in a formal, quantitative manner that would be typical for a device's regulatory approval against pre-defined performance goals. Instead, the "acceptance criteria" are implied by the comparative nature of the studies against predicate devices (LMA, face mask/Guedel airway) and the general assessment of safety and effectiveness.

    Given the information, here's an attempt to structure the response as requested, interpreting implied acceptance criteria from the study goals and findings:

    1. Table of Implied Acceptance Criteria and Reported Device Performance

    Implied Acceptance CriterionCOPA™ Performance (Reported)Notes / Source
    A. Functional and Design Conformance
    1. Conformance to ISO 5364 (Oropharyngeal airways) requirementsVerified conformance to: molding tolerances, dimensions of 15mm connectors and airway, resistance to collapse of the buccal end, resistance to distortion.Functional Testing (Bench testing of sterile prototypes)
    2. Airway integrity and consistency (e.g., cuff, bond strength)Verified: airway integrity, resting volumes and diameters of cuffs, cuff integrity, cuff herniation over distal end, strength of tail-airway bond, disconnect force of connector from breathing circuitry.Functional Testing (Bench testing of sterile prototypes)
    3. Appropriate placement and airway occlusionCuff appropriately placed in the pharynx; when inflated, it occludes the nasopharynx, displaces tongue base/epiglottis anteriorly, and seals posterior pharynx. Does not extend past the vallecula or into the esophagus, avoiding glottic/tracheal stimulation.Functional Testing (Cadaver studies - compared to predicate devices)
    4. Cuff seals at lower pressures than predicate devicesCuff seals the oropharynx at lower pressures than both the Sheridan Combi-Tube and Laryngeal Mask Airway.Functional Testing (Cadaver studies - compared to predicate devices)
    B. Clinical Effectiveness - Airway Maintenance & Ease of Use
    1. Easy device placement and maintenance of patent airway"Device placement and maintenance of a patent airway were easy." (European Study) Provided a clear airway in 98% (MAB), 100% (SB), 100% (emergence from anesthesia) in the Australian study. Equivalent to LMA in ease of use (Randomized Controlled Study).Clinical Study A (European), Clinical Study B (Australian), Clinical Study C (Randomized Controlled)
    2. Anesthetic doses comparable to predicate devices"Anesthetic doses needed for device placement and maintenance are similar to those needed for the predicate devices."Clinical Study A (European)
    3. Time to hands-free airway (compared to LMA)229 seconds (COPA) vs 137 seconds (LMA). Significantly longer for COPA (p=0.004).Clinical Study C (Randomized Controlled)
    4. Proportion of patients achieving hands-free airway (compared to LMA)9.6% (29/302) did not achieve hands-free airway with COPA vs 0.66% (1/150) with LMA. Significantly higher for COPA (p<0.001).Clinical Study C (Randomized Controlled)
    5. Need for airway manipulations (compared to LMA)Significantly more manipulations with COPA: 36.3% (>2 or continuous support) vs 0% (LMA). Total (%) 0 Manipulations: COPA 45.8% vs LMA 96%. "Although the LMA was associated with fewer airway manipulations, both devices were equivalent in establishing a safe and effective airway." Australian study indicates 21.4% required jaw lift during SB.Clinical Study C (Randomized Controlled) - Table "Airway Manipulations", Clinical Study B (Australian)
    6. Time to spontaneous breathing (compared to LMA)COPA 7.3 minutes vs LMA 6.7 minutes. Not significantly different (p=0.44).Clinical Study C (Randomized Controlled)
    C. Clinical Safety & Complication Rates
    1. Minor anesthetic sequelae comparable to predicate devices"Anesthetic sequelae (coughing, bucking, and sore throat) were minor and comparable to those occurring with use of tracheal tubes and laryngeal mask airways." Mild sore throat occurred in 4% (Australian study).Clinical Study A (European), Clinical Study B (Australian)
    2. Overall physiological tolerance and complications comparable to LMA (main study)Equivalent to LMA in physiological tolerance and minor/major complications. No unanticipated adverse device effects or life-threatening problems/deaths.Clinical Study C (Randomized Controlled)
    3. Specific adverse events comparable to LMA (main study)No significant difference (p>0.05) for: Aspiration, regurgitation, laryngospasm, succinylcholine given, wheeze, hypoxia (SaO2<92%), failed use, bucking, shivering, gagging, coughing, stridor, nasogastric tube inserted, movement. Significantly less blood detected with COPA: 5.8% vs 15.3% for LMA (p=0.001). Significantly less hiccuping with COPA: 1.7% vs 5.3% for LMA (p=0.029). Significantly less continuous chin support for LMA: 29.8% (COPA) vs 0% (LMA) (p=0.001).Clinical Study C (Randomized Controlled) - Table "Major and minor problems". Note: The table structure implies that a lower percentage is generally better for problems. The p-values indicate statistical significance when comparing COPA to LMA for each problem.
    4. Oxygen saturation maintenanceSpO2 briefly fell to 87-89% on six occasions (Australian study).Clinical Study B (Australian)

    2. Sample Sizes and Data Provenance

    • Preliminary Feasibility Study (IDE G900092):
      • Sample Size: 10 patients
      • Data Provenance: Not explicitly stated, but implies a clinical setting. Retrospective/Prospective unclear, likely prospective for the study itself.
    • Clinical Study A (European Study, August 1995):
      • Sample Size: 20 patients
      • Data Provenance: European (Specific country not stated). Likely prospective for the study itself.
    • Clinical Study B (Australian Study, July 1996):
      • Sample Size: 100 patients
      • Data Provenance: Australia (Two sites). Likely prospective.
    • Clinical Study C (Randomized Controlled Study, IDE G960100, Completed September 1996):
      • Sample Size: COPA™ arm: 302 patients (for most problems, 295 for airway manipulations); LMA arm: 151 patients (for most problems, 150 for airway manipulations).
      • Data Provenance: No specific country mentioned, but "multi-site study" implies clinical centers. Likely prospective, given it's a randomized, controlled trial.

    3. Number of Experts and Qualifications for Ground Truth

    The document does not explicitly state the number of experts used to establish ground truth for the clinical studies, nor their specific qualifications (e.g., "radiologist with 10 years of experience").

    • For the functional (cadaver) studies, the conclusions drawn ("The cuff is appropriately placed...", "The cuff seals...") would have been made by medical professionals, likely anesthesiologists or anatomists, but this is not detailed.
    • For the clinical studies, "investigators" and "clinical sites" are mentioned, implying medical professionals (anesthesiologists, nurses) were involved in patient care, data collection, and assessment of outcomes like ease of placement, airway patency, and adverse events. The "Adverse events and interventions were recorded on videotape, and by verbal commentary and hand-written notes" in the Australian study, indicating direct clinical observation.

    4. Adjudication Method for the Test Set

    The document does not explicitly describe an "adjudication method" in the typical sense (e.g., 2+1, 3+1 consensus by independent reviewers for a classification task). Data was collected through direct observation, videotape, verbal commentary, and handwritten notes. In randomized controlled trials (Clinical Study C), data collection is generally standardized per protocol, and outcomes are either objective measures or physician-reported findings. Discrepancies, if any, would typically be resolved by study investigators or a data monitoring committee, but this is not detailed.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, a MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This document describes the evaluation of a medical device (COPA™) for airway management, not an AI-assisted diagnostic or interpretive system. The comparative effectiveness studies cited (Clinical Study C) compare the COPA™ device against a predicate device (LMA) in human patients.

    6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

    No, this is not an AI/algorithm-based device. The COPA™ is a physical medical device for airway management. Therefore, a "standalone algorithm performance" study is not applicable. All studies involve the device being used by human operators (clinicians) in patients or cadavers.

    7. Type of Ground Truth Used

    The ground truth for the studies described is primarily:

    • Direct Clinical Observation/Assessment: In the clinical studies, outcomes such as ease of placement, maintenance of patent airway, anesthetic sequelae (coughing, sore throat), adverse events (e.g., hypoxia, laryngospasm), time to hands-free airway, time to spontaneous breathing, need for manipulations, etc., were assessed by observing patients, often recorded by clinicians (e.g., "videotape, and by verbal commentary and hand-written notes" in the Australian study).
    • Physiological Measurements: Objective data like positive inspiratory pressure, end-tidal carbon dioxide concentrations, oxygen saturation (SpO2).
    • Fiberoptic Assessment: In the Australian study, device positioning and visualization of vocal cords/epiglottis were assessed fiberoptically.
    • Cadaveric Observation: For functional testing, direct observation of cuff placement, occlusion, and interaction with anatomy in cadavers.
    • Bench Testing Standards: Conformance to ISO standards for physical characteristics.
    • Patient Outcomes/Symptoms: Postoperative sore throat, presence of blood, gagging, etc., are patient-reported or clinician-observed symptoms.

    8. Sample Size for the Training Set

    This concept is not applicable here. The COPA™ is a physical medical device, not a machine learning model. There is no "training set" in the context of developing an algorithm. The "training" for the device's design and use would involve iterative design/testing and clinician training.

    9. How Ground Truth for the Training Set Was Established

    Again, this is not applicable as there is no "training set" as understood in machine learning. The design and refinement of the device (what might be loosely analogous to "training" in a product development cycle) was guided by:

    • Preliminary Feasibility Studies: Identified areas for improvement (e.g., cuff shape).
    • Bench Testing: Provided objective data against standards for physical properties.
    • Cadaver Studies: Informed optimal placement and functional mechanics.
    • Early Clinical Studies: Gave feedback on ease of use, complications, and patient tolerance, leading to design modifications and further studies.

    These iterative evaluations and modifications informed the final design, but this is not "ground truth for a training set" in the AI sense.

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