(466 days)
Not Found
G900092, G960100
No
The summary describes a physical airway device and its clinical performance, with no mention of software, algorithms, or AI/ML techniques.
No.
The device is used to establish and maintain an airway during anesthesia, which is a supportive function rather than a direct treatment for a disease or condition. The clinical studies describe its use in anesthesia and maintaining a clear airway, not in therapeutic intervention.
No
Explanation: The device description and performance studies focus on airway management, ventilation, and patient comfort during anesthesia, and there is no mention of diagnosing a disease or condition. The clinical studies compare its performance to other airway devices, not diagnostic tools.
No
The summary describes bench testing of sterile prototypes, cadaver studies, and clinical studies involving device placement and maintenance, indicating a physical device rather than software. The predicate devices are also physical airway management devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information describes a device used for airway management in adults during anesthesia, specifically targeting anatomical sites like the pharynx, nasopharynx, and trachea. This is a device used in vivo (within the body) to maintain an airway, not a test performed on a sample in vitro (outside the body).
- Performance Studies: The performance studies focus on the device's ability to establish and maintain an airway, ease of use, physiological tolerance, and complications related to airway management. These are not studies evaluating the accuracy of a diagnostic test.
Therefore, the device described is an airway management device used during anesthesia, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharynx, oropharynx, nasopharynx, vallecula
Indicated Patient Age Range
anesthetized adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A European study of twenty patients. Information summarized in attached abstracts (attachment 3). An Australian study of 100 patients. Adverse events and interventions recorded on videotape, by verbal commentary, and hand-written notes. Assessment of device positioning (fiberoptically, from within the device), postoperative sore throat, and skill acquisition. A randomized, controlled, multi-site study under IDE G960100 to compare the COPA device to the LMA in patients undergoing spontaneously breathing general anesthesia.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preliminary Feasibility Studies:
- An earlier design of this device was evaluated in a clinical study under IDE G900092 with ten patients.
- Results: No difference between positive inspiratory pressure necessary to generate adequate ventilation volumes before placement (face mask only), during placement with COPA cuff deflated, or during placement with COPA cuff inflated. Use of the device did not affect end-tidal carbon dioxide concentrations. No patient had a complication.
Functional Testing:
- Bench testing of sterile prototypes verified conformance to ISO 5364 -- Oropharyngeal airways for: molding tolerances, dimensions of 15 mm connectors and airway, resistance to collapse of the buccal end, resistance to distortion.
- Bench testing also verified integrity and consistency of the product in: airway integrity, resting volumes and diameters of cuffs, cuff integrity, cuff herniation over the distal end of the airway, strength of the tail-airway bond, disconnect force of the connector from the breathing circuitry.
- Cadaver studies (Attachment 5) comparing COPA device to predicate devices.
- Results: Cuff appropriately placed and occludes nasopharynx, displaces base of tongue and epiglottis anteriorly, and seals posterior pharynx when inflated. Seals oropharynx at lower pressures than Sheridan Combi-Tube and Laryngeal Mask Airway. Does not extend inferiorly past vallecula or into esophagus, reducing potential for glottic or tracheal stimulation.
Clinical Studies:
- A. Conducted August 1995: European study of twenty patients.
- Results: Device placement and maintenance of a patent airway were easy. Anesthetic sequelae (coughing, bucking, sore throat) were minor and comparable to tracheal tubes and laryngeal mask airways. Anesthetic doses for placement and maintenance similar to predicate devices.
- B. Conducted July 1996: Two-site Australian study on 100 patients for spontaneously breathing anesthesia.
- Results: Clear airway in 98% during manually assisted breathing (MAB), 100% during spontaneous breathing (SB) and emergence. Useful interventions: jaw lift and head rotation. Less useful: size changes, slight withdrawal, changing cuff volume. Most interventions in first three minutes of each phase. Jaw lift (manual or mechanical chinlift) required for 21.4% of time during SB. SpO2 briefly fell to 87-89% on six occasions. During SB, vocal cords visible in 29%, epiglottis in 90%. Excellent emergence characteristics. Mild sore throat in 4%. Tentative evidence for skill acquisition. Investigators concluded COPA suitable for spontaneous breathing anesthesia. Most patients require interventions for clear airway. Performance characteristics of a "hands-free" face mask/Guedel airway. Well tolerated, low complication rate.
- C. Completed September 1996: Randomized, controlled, multi-site study under IDE G960100 comparing COPA and LMA in spontaneously breathing general anesthesia (COPA: 302 patients, LMA: 151 patients).
- Results: COPA and LMA are equivalent in ease of use, physiological tolerance, and minor/major complications. LMA associated with fewer airway manipulations, but both equivalent in establishing safe and effective airway for spontaneously breathing anesthetized adults. No unanticipated adverse device effects, life-threatening problems, or deaths. Time to hands free airway (seconds): COPA 229 (310), LMA 137 (121). Significantly shorter for LMA (p=0.004). Significantly more patients did not achieve a hands free airway with COPA (29/302 = 9.6%) than LMA (1/150 = 0.66%) (p2 or continuous support: COPA 107/295 (36.3%), LMA 0/150 (0%)
- Total: COPA 295 (100%), LMA 150 (100%)
- Major and minor problems reported:
- aspiration: COPA 1/302 (0.3%), LMA 0/151 (0%), p=0.479
- regurgitation: COPA 2/302 (0.7%), LMA 1/151 (0.7%), p=1.000
- laryngospasm: COPA 6/302 (2%), LMA 2/151 (1.3%), p=0.614
- succinylcholine given: COPA 5/302 (1.7%), LMA 0/151 (0%), p=0.112
- wheeze: COPA 1/302 (0.3%), LMA 0/151 (0%), p=0.479
- 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.
0
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9655721'. The numbers are written in a cursive style, with some of the digits connected to each other.
Non-Confidential Safety and Effectiveness Summary
Preliminary Feasibility Studies
MAR 28 1997
An earlier design of this device was evaluated in a clinical study under IDE G900092. In that study, ten patients were studied with the device in place during emergence from a short general anesthetic. There was no difference between positive inspiratory pressure necessary to generate adequate ventilation volumes before placement of the device, (face mask only), during placement with the COPA™ cuff deflated, or during placement with the COPA"" cuff intflated. Use of the device did not affect end-tidal carbon dioxide concentrations. No patient had a complication as a result of participating in the study.
Design Modifications
While the preliminary studies demonstrated the feasibility of the COPA™ device, they also implied that a change in the shape of the inflatable cuff would improve that reliability of the device. All later studies were performed on devices with a cuff design as indicated in the attached drawing.
Functional Testing
Bench testing of sterile prototypes verified conformance to ISO 5364 -- Oropharyngeal airways, in its requirements for:
- molding tolerances ﻨﺴ
- dimensions of 15 mm connectors and airway 2.
- resistance to collapse of the buccal end 3.
-
- resistance to distortion
Bench testing of sterile prototypes also verified the integrity and consistency of the product in the following areas:
- airway integrity 1.
- resting volumes and diameters of cuffs 2.
-
- cuff integrity
- cuff herniation over the distal end of the airway 4.
-
- strength of the tail-airway bond
- disconnect force of the connector from the breathing circuitry 6.
The functionality of the COPA™ device was compared to that of predicate devices in cadaver studies. (See attachment 5) The results of these studies show that:
- The cuff is appropriately placed in the pharynx when the device is placed as directed in the product insert. -When inflated, the cuff occludes the nasopharynx and displaces the base of the tongue and epiglottis anteriorly while sealing the posterior pharynx.
- The cuff seals the oropharynx at lower pressures than both the Sheridan Combi-Tube and the Laryngeal 2. Mask Airway.
- The COPATM airway does not extend inferiorly past the vallecula or into the esophagus. Therefore, it does 3. not raise the potential for glottic or tracheal stimulation in an anesthetized patient.
1
Clinical Studies
-
A. Conducted August 1995.
The current design was evaluated in a European study of twenty patients. The results of this study, as summarized in the attached abstracts, (attachment 3) show that: -
Device placement and maintenance of a patent airway were easy. 1.
-
Anesthetic sequelae (coughing, bucking, and sore throat) were minor and comparable to those 2 occurring with use of tracheal tubes and laryngeal mask airways.
-
Anesthetic doses needed for device placement and maintenance are similar to those needed for the 3. predicate devices.
-
B. Conducted July 1996
A two-site Australian study was conducted on 100 patients to evaluate the COPA™ device for spontancously breathing anesthesia. During airway maintenance with the COPA™ device, adverse events and interventions were recorded on videotape, and by verbal commentary and hand-written notes. An assessment was made of device positioning (fiberoptically, from within the device), postoperative sore throat, and skill acquisition. The COPATM device provided a clear airway in 98% of the patients during manually assisted breathing (MAB), 100% during spontaneous breathing (SB) and emergence from anesthesia. Useful interventions were jaw lift and rotation of the head. Less useful were size changes, withdrawing the COPA 104 device slightly, or changing cuff volume. Most interventions occurred during the first three minutes of each phase. Jaw lift (manual or mechanical chinlift) was required for 21.4% of the time during SB. The oxygen saturation (SpO2) briefly fell to 87-89% on six occasions. During SB the vocal cords were visible (from a vantage point of just inside the distal tip of the device)in 29% and the epiglottis in 90%. Emergence characteristics were excellent. Mild sore throat occurred in 4%. There was tentative evidence for skill acquisition. The investigators concluded that the cuffed oropharyngeal airway is suitable for spontaneous breathing anesthesia. Most patients require one or more interventions to provide a clear airway. The device has the performance characteristics of a relatively "hands-free" face mask/Guedel airway. It is well tolerated and has a low complication rate.
- C. Completed September 1996
A randomized, controlled, multi-site study was carried out under IDE G960100 to compare the safety, efficacy, and utility of the COPA " device to that of the laryngeal mask airway (LMA) in patients undergoing spontaneously breathing general anesthesia. The results of this study indicate that the COPA™ device and the LMA are equivalent devices in terms of 1) ease of use, 2)physiological tolerance and 3)minor and major complications. Although the LMA was associated with fewer airway manipulations, both devices were equivalent in establishing a safe and effective airway for spontaneously breathing anesthetized adults. There were no reports of unanticipated adverse device effects on the health or safety of the patients, or any life threatening problems or deaths caused by or associated with either tested device in this study. The time to hands free airway (seconds) was 229 (310) for the COPA and 137 (121) for LMA. It was significantly shorter for the LMA (p=0.004.) There were significantly more patients who did not achieve a hands free airway with the COPA (29/302 = 9.6%) than the LMA (1/150 = 0.66%) (p2 or continuous support | 107/295 (36.3) | 0/150 (0) |
| Total | 295 (100) | 150 (100) |
Airway manipulations post-incision - propofol off. Total (%)
2
| Major and minor problems reported are summarized in the following table: | ||||
|---|---|---|---|---|
| Problems occurring during use of the device: events/patients (%) | ||||
| type | COPA | LMA | p value | |
| Chi Squared | ||||
| aspiration | 1/302 (0.3) | 0/151 (0) | 0.479 | |
| regurgitation | 2/302 (0.7) | 1/151 (0.7) | 1.000 | |
| laryngospasm | 6/302 (2) | 2/151 (1.3) | 0.614 | |
| succinylcholine given | 5/302 (1.7) | 0/151 (0) | 0.112 | |
| wheeze | 1/302 (0.3) | 0/151 (0) | 0.479 | |
| hypoxia (SaO2 |