(702 days)
Not Found
No
The device description focuses on mechanical components and air pressure delivery, with no mention of AI or ML technologies. The performance studies compare flow and pressure characteristics, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel." Additionally, its function in delivering nCPAP for Sleep Apnea addresses a medical condition.
No
The provided text explicitly states that the device's "Intended Use / Indications for Use" is as a "therapeutic device." It is used for delivering nCPAP as a treatment and does not mention any diagnostic capabilities.
No
The device description clearly outlines physical components such as cannulae, cuffs, tubes, and a foam pad, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "therapeutic device" used for delivering nCPAP as a treatment for Sleep Apnea. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a device that facilitates the delivery of air pressure to the patient's airways. It does not describe any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical sites mentioned (nares, nasal passage, oral pharynx, trachea, lungs) are where the device interacts with the patient's respiratory system, not where biological samples would be collected or analyzed for diagnostic purposes.
- Performance Studies: The performance studies focus on the device's ability to deliver flow and pressure for nCPAP therapy and patient tolerance, not on the accuracy or reliability of diagnostic measurements.
- Predicate Device: The predicate device is also a nasal CPAP circuit, further indicating its therapeutic nature.
In summary, the Airways Nasalflair is a therapeutic device used to deliver positive airway pressure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel. Nasalflair is used by patients who have been prescribed nCPAP as a treatment for Sleep Apnea. Nasalflair may be used with CPAP and flow generators capable of generating 20 t 2 cmH20 pressure via a 22mm I.D. main flow air supply tube.
Product codes
BZD
Device Description
Nasalflair is a device that fits into patient's nares in a way that makes a substantially airtight seal, which facilitates the delivery of nasal Continuous Positive Airway Pressure (nCPAP) The device has two cannulae that fit into the patient's therapy. nares. Surrounding the tip of each cannulae are cuffs that inflate to create a seal around the cannulae just inside the The cuffs are inflated through an aperture in the nares. cannulae wall with the same air and pressure the patient is Pressure inside the inflated cuffs is equal to the breathing. pressure in the airway, thereby providing an adequate airtight seal. The cuffed cannula tips are elliptical, and swivel for They snap onto and off of the J pieces maximum patient comfort. to facilitate cleaning and economical replacement. The J pieces They also have a fixed have a tab to hold a stabilizing strap. The J pieces curve orifice to provide a vent for exhalation. back up over the nose to the forehead area where they connect to A corrugated tube connects the Y piece to the flow a Y piece. generator.
Prescribed positive pressure is produced and regulated by the flow generator. Gas flow travels from the flow generator through a 22mm I.D. corrugated tube that connects to the Nasalflair wye piece which splits the flow and sends it through two flexible lSmm I.D tubes, each connects to a J shaped piece having cuffed cannulae that fit into patient's nares directing the air flow into the nasal passage, oral pharynx, trachea, and into the lungs .
The Y piece is attached to a soft nylon lined foam pad that rests on the patient's forehead and is held in place with adjustable hook/loop straps. Different types of head gear may be used depending on individual patient preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nares, nasal passage, oral pharynx, trachea, lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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
Not Found
Summary of Performance Studies
Safety: Performance testing (with consideration to flow and pressure) through Nasalflair and Adams Circuit were completed and compared using five different commercially available CPAP flow generators at four pressure levels (5cmH20, 10cmH20, 15cmH20, 20cmH20). The results demonstrated that Nasalflair and Adams Circuit are substantially equivalent at providing flow and pressure appropriate for nCPAP therapy.
Effectiveness: Clinical trials were completed with ten patients using Nasalflair. Patients were selected who could not tolerate the mechanical pressure needed to create an air tight seal when using the Adams Circuit. The study found that Nasalflair's inflatable cuff sealing mechanism provides improved comfort compared to the mechanical pressure of the Adams Circuit, allowing patients to tolerate higher CPAP pressures. Ten patients have been using Nasalflair for >24 months and found it to be a safe and effective interface for positive pressure breathing therapy.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
1997
510 (K) SUMMARY NASAL CANNULA FOR CONTINUOUS POSITIVE AIRWAY PRESSURE R-AN (73) CLASS: II BZD
l. Submitted by:
Airways Limited Inc. 144 Lower Main Street Matawan, NJ. 07747 . Tel. 908-583-8003 Fax. 908-583-6335
Contact Person:
Wayne W. Disanza
Date:
Sept. 9, 1996
Device name:
Nasalflair
-
- Predicate device:
Puritan Bennett . Single Patient Use Nasal CPAP AN-FRE-SE Class II (K900164) 02D Adams Circuit
- Predicate device:
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3. Description of Nasalflair:
Nasalflair is a device that fits into patient's nares in a way that makes a substantially airtight seal, which facilitates the delivery of nasal Continuous Positive Airway Pressure (nCPAP) The device has two cannulae that fit into the patient's therapy. nares. Surrounding the tip of each cannulae are cuffs that inflate to create a seal around the cannulae just inside the The cuffs are inflated through an aperture in the nares. cannulae wall with the same air and pressure the patient is Pressure inside the inflated cuffs is equal to the breathing. pressure in the airway, thereby providing an adequate airtight seal. The cuffed cannula tips are elliptical, and swivel for They snap onto and off of the J pieces maximum patient comfort. to facilitate cleaning and economical replacement. The J pieces They also have a fixed have a tab to hold a stabilizing strap. The J pieces curve orifice to provide a vent for exhalation. back up over the nose to the forehead area where they connect to A corrugated tube connects the Y piece to the flow a Y piece. generator.
Prescribed positive pressure is produced and regulated by the flow generator. Gas flow travels from the flow generator through a 22mm I.D. corrugated tube that connects to the Nasalflair wye piece which splits the flow and sends it through two flexible lSmm I.D tubes, each connects to a J shaped piece having cuffed cannulae that fit into patient's nares directing the air flow into the nasal passage, oral pharynx, trachea, and into the lungs .
The Y piece is attached to a soft nylon lined foam pad that rests on the patient's forehead and is held in place with adjustable hook/loop straps. Different types of head gear may be used depending on individual patient preference.
- Intended use:
The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel. Nasalflair is used by patients who have been prescribed nCPAP as a treatment for Sleep Apnea. Nasalflair may be used with CPAP and flow generators capable of generating 20 t 2 cmH20 pressure via a 22mm I.D. main flow air supply tube.
2
Statement of Comparison to Predicate Device: 5.
The Airways Nasalflair is substantially equivalent to the Puritan patient interfaces used with CPAP and BiPAP™ flow generators capable of generating 20 ± cmH20 pressure via a 22mm I.D. main Both devices use similar head gear to hold flow air supply tube. the device over the patient's face engaging and sealing the nasal airway during sleep. Adams Circuit head gear may be used with Nasalflair and vice versa. Both devices produce a substantially airtight fit at the nares opening to produce CPAP. Nasalflair makes an airtight seal with an inflatable cuff on the inner wall The Adams Circuit makes an airtight seal with of the nares. mechanical pressure against the opening of the nares. Nasalflair and Adams Circuit provide nCPAP pressure and flow characteristics that are substantially equivalent.
Safety and Effectiveness: 6 .
SAFETY :
Performance testing, (with consideration to flow and pressure) through Nasalflair and Adams Circuit were completed and compared. While flow performance standards have not been established for devices of this type, it is important the device provide sufficient flow to maintain the desired CPAP pressure and satisfy peak inspiratory demands of patients at rest.
Testing was performed using five different commercially available CPAP flow generators. These flow generators were selected to provide a representative cross section of flow generators used by patients when prescribed nCPAP therapy.
Each flow generator was adjusted to operate at four different pressure levels. These pressure levels, 5cmH20, 10cmH20, 15cmH20, 20cmH20, represent the maximum range of preseure use during nCPAP therapy.
The results of the testing demonstrates that Nasalflair and Adams Circuit are substantially equivalent at providing flow and pressure appropriate for nCAPA therapy.
3
EFFECTIVENESS :
Clinical trials have been completed with ten patients using Nasalflair. The patients were informed Nasalflair is not an FDA approved device and consented to use it as such.
Patients were selected who could not tolerate the mechanical pressure needed to create an air tight seal when using the Adams Circuit. The subtle yet important difference between the two interfaces focuses on how the airtight seal is made at the nares openings, and how each affects patient comfort. Adams Cìrcuit head gear needs to maintain tension on the straps that hold the nasal pillows snugly into the nares. The higher the prescribed CPAP pressure, the more tension is required to maintain the airtight fit.
Patients with prescribed CPAP pressure above 10cmH20 are frequently unable to tolerate the amount of tension required to get a proper seal. They tolerate the tension for a few days, but then stop the prescribed treatment due to discomfort, soreness, tissue breakdown or persistent leakage.
replaced Adams Circuit in 10 of these cases. Nasalflair has Nasalflair head gear straps do not need to maintain tension to hold the nasal cannulae into the nares. The head gear straps only need to be snug enough to maintain the position of the cannulae in the nares. The airtight seal is made with the inflation of the cuffs on the cannulae in the nares. The cuffs are inflated with the same qas and CPAP pressure the patient is The higher the CPAP pressure, the higher the cuff breathing. inflation pressure. Head gear straps do not need to be made tighter to accomplish an air-tight seal with higher CPAP pressures. Also, pressure from the inflated cuffs is distributed evenly around the cuff surface where it contacts the nares, avoiding pressure points that are usually present with mechanical forces .
Some patients on long term use of Nasalflair reported nasal dryness. Humidity was added into the breathing air which eliminated the nasal dryness. Humidity is routinely added to the air when the Adams Circuit is used. The Nasalflair label cautions that optional humidity may be added to the air to avoid nasal dryness.
Ten patients have now been using Nasalflair for >24 months. They have found Nasalflair to be a safe and effective interface for positive pressure breathing therapy.
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