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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 Criterion | COPA™ Performance (Reported) | Notes / Source |
|---|---|---|
| A. Functional and Design Conformance | ||
| 1. Conformance to ISO 5364 (Oropharyngeal airways) requirements | Verified 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 occlusion | Cuff 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 devices | Cuff 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 (p2 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 |
§ 868.5110 Oropharyngeal airway.
(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.