(492 days)
The cNEP Airway Management System is to be used as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.
The cNEP Airway Management System is a silicone rubber collar that is attached to the neck by a hydrogel and provides negative suction through a regulated vacuum source (see Figure 1). The vacuum suction allows the device to provide a patent airway during mild to moderate sedation.
1. Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| In Vitro Cytotoxicity | To assess the biological reactivity of device extracts | Non-cytotoxic | Non-cytotoxic |
| Sensitization | To assess the sensitization potential of device extracts | Non-sensitizing | Non-sensitizing |
| Irritation | To assess the irritation potential device extracts | Non-irritating | Non-irritating |
| Bench Testing | |||
| Collar Seal Maintenance | Demonstrate that the collar seal is not lost and maintained a seal during the procedure | Un-occluded reading gauge reading should equal occluded gauge reading | Pass |
| Patient Repositioning | Demonstrate the ability to reposition a patient while wearing the device | Device must remain on subject at operating vacuum. | Pass |
| Jaw Thrust | Demonstrate the ability for a caregiver to execute mandibular advancement (jaw thrust) while the device is applied | Ability to displace mandible forward. | Pass |
| Ability to Talk | Demonstrate the patient can talk with medical professionals while wearing the device | The subject must be able to speak during use. | Pass |
| Mouth Accessibility | Demonstrate medical professional can have full access to the patient's mouth while wearing the device | Device remains in place when patient opens their mouth. | Pass |
| Device Application on Side | Demonstrate the ability for a caregiver to apply the device to a patient while he/she is lying on their side | Device can be applied to subject. | Pass |
| Operational Testing at High and Low Temperature | Demonstrate accuracy of the operational vacuum zone cutoff boundary | Vacuum level within $40 \pm 2$ cm H2O | Pass |
| Drop Test | Demonstrate the device's ability to resist damage associated with inadvertent dropping | Device does not have damage and pass functional test | Pass |
| Low and High Temperature Storage | Demonstrate the device's ability to function properly after being stored in a hot/cold environment | No visual damage and pass functional test | Pass |
| Device Leakage | Demonstrate the device maintains vacuum | Vacuum level to be greater than 40 cmH2O | Pass |
| Clinical Study (5iS-009) | |||
| Primary Endpoint: Respiratory Impairment (RI) Incidents | The frequency of respiratory impairment (RI) events (decline in oxygenation or apneas > 15s) in the treatment (cNEP) group compared to the control group. | Statistically significant reduction in RI events in the cNEP group compared to control. | Mean RI events: Control = 3.5, cNEP = 1.92. Statistically significant difference for oxygen supplementation (p=0.01) and apnea events (p=0.0006). |
| Secondary Endpoint: Safety (Adverse Events) | The safety of cNEP Airway Management System as determined by adverse events reported by the investigators. | Acceptable safety profile with no serious device-related adverse events. | Cutaneous erythema in 41.3% of cNEP users, resolved within 20 minutes. No effect on heart rate or respiration. |
| Secondary Endpoint: Incidence of RI subjects | The incidence of subjects with one or more RI in the treatment group compared to the control group. | Reduction in incidence of subjects with one or more RI in the cNEP group. | Not explicitly reported as a separate number, but implied by the primary endpoint results. |
| Secondary Endpoint: Frequency of Interventions | The frequency of interventions to alleviate RI in the treatment group compared to the control group. | Reduction in interventions required to alleviate RI in the cNEP group. | 10% in cNEP group required increased oxygen, 3% required jaw thrust. 42% in control group required increased oxygen. |
| Clinical Study (5iS-010 & 5iS-10B) | |||
| Primary Endpoint: Carotid Blood Flow | The change in common carotid blood flow measured at baseline and at the end of timed exposure to cNEP. | No statistically significant detrimental change in carotid blood flow. | No statistically significant difference in common carotid blood flow between control and cNEP treatment arm. Trivial overall increase in blood flow observed. |
| Secondary Endpoint: Safety (Adverse Events) | The safety of cNEP Airway Management System as determined by adverse events observed by the investigators. | Acceptable safety profile with no serious device-related adverse events. | No device-related adverse events reported. |
| Secondary Endpoint: Safety (Vital Signs) | The safety of cNEP Airway Management System as determined by assessing any change in vital signs measured at baseline and compared to while on cNEP. | No statistically significant detrimental changes in vital signs. | No statistically significant difference in vital signs (systolic BP, diastolic BP, heart rate, respiratory rate) between groups. |
2. Sample Sizes and Data Provenance
- Study 5iS-009:
- Test Set Sample Size: 54 subjects (24 control, 30 treatment).
- Data Provenance: Retrospective (implied by study design referring to "routine colonoscopy"), country of origin not specified.
- Study 5iS-010:
- Test Set Sample Size: 8 subjects.
- Data Provenance: Not specified (implied prospective by protocol description), country of origin not specified.
- Study 5iS-10B:
- Test Set Sample Size: 9 subjects.
- Data Provenance: Not specified (implied prospective by protocol description), country of origin not specified.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- The provided text does not mention the use of experts to establish ground truth for the clinical studies in the context of adjudication or independent review.
- For Study 5iS-009, the "Primary Endpoint" definitions for respiratory impairment (decline in oxygenation by pulse oximetry and apneas defined by AASM Scoring Manual, 2007) and "Secondary Endpoints" such as "adverse events reported by the investigators" imply that these assessments were made by the investigators themselves, rather than a separate panel of experts for ground truth establishment.
- For studies 5iS-010 and 5iS-10B, the "Primary Endpoint" refers to carotid blood flow by Doppler ultrasound, which is an objective measurement. "Adverse events observed by the investigators" again suggests investigator-based assessment.
4. Adjudication Method for the Test Set
- The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 consensus) for the clinical studies or the establishment of ground truth for the test sets. Assessments appear to be based on direct measurements (e.g., pulse oximetry, Doppler ultrasound) or investigator reports.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The studies described are clinical trials comparing the device to standard care or assessing its impact on physiological parameters, not studies evaluating human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The cNEP Airway Management System is a physical medical device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study was not conducted.
7. Type of Ground Truth Used
- Study 5iS-009:
- Primary Endpoint: Objective physiological measurements (pulse oximetry for oxygenation decline, AASM 2007 criteria for apnea duration)
- Secondary Endpoints: Investigator-reported adverse events and observations (e.g., need for interventions).
- Studies 5iS-010 & 5iS-10B:
- Primary Endpoint: Objective physiological measurements (Doppler ultrasound for common carotid blood flow).
- Secondary Endpoints: Investigator-observed adverse events and vital sign measurements.
8. Sample Size for the Training Set
- Not applicable. As this is a physical device, there is no "training set" in the context of machine learning or AI.
9. How Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this physical device.
§ 868.5105 External negative pressure airway aid.
(a)
Identification. An external negative pressure airway aid is a prescription device that applies negative pressure to a patient's neck to aid in providing a patent airway during procedures requiring anesthesia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must document any adverse events observed during clinical use, including impaired blood flow, and demonstrate that the device performs as intended under anticipated conditions.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated patient positions, does not fail during use, and does not lose negative pressure capability. The following testing should be performed:
(i) Ability of the device to maintain a seal during various patient positions;
(ii) Device leakage testing to demonstrate the device maintains vacuum;
(iii) Drop testing to ensure the device does not incur functional damage after dropping the device; and
(iv) Functional testing after high and low storage temperature.
(3) All patient contacting components must be demonstrated to be biocompatible.
(4) Labeling must include:
(i) A summary of clinical testing results, including any adverse events and evidence that effectiveness has been achieved.
(ii) Technical specifications of the device, including collar sizes, maximum duration of use, operating temperature, and storage temperature range.
(iii) Technical specifications of the vacuum source, including maximum vacuum level and operational vacuum level.
(iv) Instructions for use that includes how to place the device, determination of size, verification of suction, reference to training materials, and information on troubleshooting the device if it does not attach properly.
(v) A warning to screen patients for carotid artery disease due to the probable risk of the device to dislodge arterial plaques in the carotid artery.
(vi) A warning to exclude patients with anatomical abnormalities.
(vii) A warning not to use the device during medical procedures involving medications that contain propofol.