(203 days)
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No
The device description and performance studies focus on the mechanical function and flow characteristics of the mask and adapter, with no mention of AI or ML.
No.
The device is described as an "accessory for compatible nebulizers" and an "adapter" that enables nebulized drugs to be delivered. It facilitates a therapeutic process but is not a standalone therapeutic device itself.
No
Explanation: The device is described as an accessory for compatible nebulizers, enabling the delivery of nebulized drugs to patients requiring elevated inspired oxygen. Its function is to facilitate drug delivery rather than to diagnose a condition.
No
The device description clearly describes a physical adapter made of Santoprene, a thermoplastic elastomer material, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver nebulized drugs and elevated inspired oxygen concentrations to patients. This is a therapeutic and respiratory support function, not a diagnostic one.
- Device Description: The description details a mask and adapter for delivering medication and oxygen to a patient's airway. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, screening, or monitoring of a disease or condition
The device is clearly intended for direct patient treatment and respiratory support, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is -intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Aerosol Adapter for the Hi-Ox® is an adapter that enables standard small-volume nebulizers (use only cup type, gas driven nebulizers without tee-fittings or air entrainment ports) with either 18 mm OD or 22 mm ID outlet ports to be adapted to the Hi-Ox® . This will enable patients to be treated with nebulized products while receiving high concentrations of oxygen at moderate flow rates of 8 -10 lpm. The valves in the Hi-Ox® have been tested and found to function normally after nebulization of some commonly nebulized drugs in aqueous formulations. However, the valves could malfunction if the prescribed drug creates a sticky residue on the valves. The practitioner should observe the patient's respiration and the function of the Hi-Ox valves during and after nebulization of drugs via the Hi-Ox80
The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for
the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer.
The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Flow resistance of all the one-way valves in the Hi-Ox® employed have been found to be well below the design target of
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
SMDA Summary: ର)
Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter - Summary of Safety and Effectivenesss
| Company: | SensorMedics Corporation |
|---|---|
| Address: | 22705 Savi Ranch Parkway |
| Yorba Linda, CA 92887 | |
| Telephone: | 714 283-2228 |
| Fax: | 714 283-8426 |
Contact:
Yvette Lloyd
Proprietary Name:
Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter
Common Name:
Oxygen Mask with Nebulizer Adapter
Intended Use:
The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is -intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.
Description of the Device:
The Aerosol Adapter for the Hi-Ox® is an adapter that enables standard small-volume nebulizers (use only cup type, gas driven nebulizers without tee-fittings or air entrainment ports) with either 18 mm OD or 22 mm ID outlet ports to be adapted to the Hi-Ox® . This will enable patients to be treated with nebulized products while receiving high concentrations of oxygen at moderate flow rates of 8 -10 lpm. The valves in the Hi-Ox® have been tested and found to function normally after nebulization of some commonly nebulized drugs in aqueous formulations. However, the valves could malfunction if the prescribed drug creates a sticky residue on the valves. The practitioner should observe the patient's respiration and the function of the Hi-Ox valves during and after nebulization of drugs via the Hi-Ox80
The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for
1
the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer.
The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.
Clinical and Non-Clinical Tests of Equivalency:
Most aerosol adapters, which are considered as Class I devices, connect a nebulizer either directly to a disposable aerosol mask or via a right-angle adapter to a mouthpiece. The Aerosol Adapter for the Hi-Ox 0 is equivalent to a right-angle adapter that connects a nebulizer to a mask. The Aerosol Adapter for the Hi-Ox80 would have the same effects on nebulizer performance as any other tee-fitting for nebulizer connections.
Flow resistance of all the one-way valves in the Hi-Ox® employed have been found to be well below the design target of