(702 days)
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.
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.
Despite the request for a comprehensive analysis, the provided text for K951944 on the "Nasalflair" device is a 510(k) summary from 1997, focusing on substantial equivalence to a predicate device rather than rigorous efficacy or safety studies with specified acceptance criteria.
Therefore, many of the requested categories for device acceptance criteria and study details cannot be fully or accurately addressed from the provided limited information.
Here's an attempt to extract and infer information based on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Explicitly Stated or Inferred) | Reported Device Performance (Nasalflair) |
|---|---|---|
| Flow and Pressure Equivalence | Sufficient flow to maintain desired CPAP pressure and satisfy peak inspiratory demands at rest across various CPAP generators and pressure levels (5, 10, 15, 20 cmH2O). | "Nasalflair and Adams Circuit are substantially equivalent at providing flow and pressure appropriate for nCAPA therapy." (Based on performance testing) |
| Airtight Seal Mechanism | Ability to create a "substantially airtight seal" for nCPAP delivery. | Achieves airtight seal with an inflatable cuff on the inner wall of the nares. (Mechanism different from predicate but achieves same function) |
| Patient Comfort/Toleration (Inferred) | Improved patient comfort/toleration compared to predicate, especially at higher CPAP pressures. | 10 patients intolerant to Adams Circuit due to mechanical pressure/discomfort tolerated Nasalflair. "Have found Nasalflair to be a safe and effective interface..." |
| Long-term Use (Inferred Safety/Effectiveness) | Safe and effective for extended use. | 10 patients used Nasalflair for >24 months, finding it safe and effective. |
| Nasal Dryness (Mitigation) | Ability to address potential nasal dryness. | Initial reports of nasal dryness mitigated by adding humidity, which is routine with predicate. Label cautions for optional humidity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 patients for the clinical "effectiveness" evaluation. Performance testing (flow and pressure) used "five different commercially available CPAP flow generators" and "four different pressure levels" within a lab setting, not a patient-specific test set.
- Data Provenance: The clinical evaluation involved patients who "consented to use it as such" (not FDA approved at the time of the study), implying a prospective, small-scale clinical observation within a clinical setting. The country of origin is not explicitly stated, but the submission is from a US company (Matawan, NJ). It's likely a small-scale, internal clinical observation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "effectiveness" section describes a clinical observation with patients but does not detail how ground truth regarding their comfort, tolerance, or perceived effectiveness was formally established (e.g., through structured assessments by independent experts).
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the "clinical trials" (more an observational patient series), a formal adjudication method for patient outcomes or "ground truth" is unlikely to have been documented or implemented in the way it would be for a modern clinical trial assessing specific endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this device. The Nasalflair is a medical device (nasal cannula for CPAP), not an AI diagnostic or interpretive system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. The Nasalflair is a physical medical device, not an algorithm. Performance testing on flow and pressure was a standalone evaluation of the device's physical properties.
7. The Type of Ground Truth Used
- For Performance Testing (Flow and Pressure): "Substantial equivalence" to the predicate device's flow and pressure characteristics was the "ground truth" or benchmark. This was measured against established physical principles of fluid dynamics.
- For "Effectiveness" (Clinical Observation): The "ground truth" was largely anecdotal and observational:
- Patients' inability to tolerate the predicate device due to mechanical pressure.
- Patients' reported tolerance, comfort, and ongoing use of the Nasalflair, indicating perceived safety and effectiveness for positive pressure breathing therapy.
- Observation of mitigation strategies for side effects (e.g., adding humidity for dryness).
8. The Sample Size for the Training Set
This concept is not applicable in the context of this 1997 medical device submission. The Nasalflair is a physical device, not an AI model requiring a training set. The clinical observations were more akin to pilot testing or early user feedback, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
As above, this is not applicable as there was no "training set" for an AI model. For the clinical observations, the "ground truth" was established through direct patient experience and feedback (e.g., "Patients were selected who could not tolerate the mechanical pressure..."), and the clinicians' observations of continued use and reported satisfaction.
§ 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).