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High Flow/High Velocity Humidified Oxygen Delivery Device

Page Type
Product Code
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
Physical State
This device can have a means of delivering humidified high flow and/or high velocity oxygen that may include high flow nasal cannula. The device may have a mechanical means of blending oxygen to the appropriate concentration.
Technical Method
The device introduces humidified high flow and/or high velocity oxygen into the respiratory system.
Target Area
Lung, airways, nasal passages
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5454
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5454 High flow humidified oxygen delivery device

§ 868.5454 High flow humidified oxygen delivery device.

(a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

(i) Alarm testing must be performed;

(ii) Continuous use thermal stability testing must be performed;

(iii) Humidity output testing must be performed; and

(iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2) blending accuracy.

(3) Performance data must validate cleaning instructions for any reusable components of the device.

(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) A description of available FiO2 ranges for different flowrates and inlet gas pressures;

(ii) Instructions for applicable flowrates for all intended populations;

(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;

(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and

(v) A description of all alarms and their functions.

[83 FR 54007, Oct. 26, 2018]

High Flow/High Velocity Humidified Oxygen Delivery Device

Page Type
Product Code
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
Physical State
This device can have a means of delivering humidified high flow and/or high velocity oxygen that may include high flow nasal cannula. The device may have a mechanical means of blending oxygen to the appropriate concentration.
Technical Method
The device introduces humidified high flow and/or high velocity oxygen into the respiratory system.
Target Area
Lung, airways, nasal passages
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5454
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5454 High flow humidified oxygen delivery device

§ 868.5454 High flow humidified oxygen delivery device.

(a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

(i) Alarm testing must be performed;

(ii) Continuous use thermal stability testing must be performed;

(iii) Humidity output testing must be performed; and

(iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2) blending accuracy.

(3) Performance data must validate cleaning instructions for any reusable components of the device.

(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) A description of available FiO2 ranges for different flowrates and inlet gas pressures;

(ii) Instructions for applicable flowrates for all intended populations;

(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;

(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and

(v) A description of all alarms and their functions.

[83 FR 54007, Oct. 26, 2018]