Last synced on 24 June 2022 at 11:05 pm

External Airway

Page Type
Product Code
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Physical State
The device is a silicone collar that is attached by adhesive and stays on with negative pressure suction.
Technical Method
The device provides negative pressure (suction)to the neck through a tube that attaches to the wall outlet of a central vacuum system. The negative pressure is monitored by a user provided regulator that displays the pressure.
Target Area
The target area is the surface of the mandible and neck which overlay the upper airway tract.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5105
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5105 External negative pressure airway aid

§ 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.

[82 FR 60867, Dec. 26, 2017]

External Airway

Page Type
Product Code
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Physical State
The device is a silicone collar that is attached by adhesive and stays on with negative pressure suction.
Technical Method
The device provides negative pressure (suction)to the neck through a tube that attaches to the wall outlet of a central vacuum system. The negative pressure is monitored by a user provided regulator that displays the pressure.
Target Area
The target area is the surface of the mandible and neck which overlay the upper airway tract.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5105
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5105 External negative pressure airway aid

§ 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.

[82 FR 60867, Dec. 26, 2017]