(112 days)
The Swift™ Air channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The Swift Air is:
- to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
- intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
The Swift™ Air provides an interface such that air flow from a positive pressure source is directed to the patient's nasal nares. The mask is held in place with adjustable headgear that straps the mask to the face.
Swift™ Air is a prescription device supplied non-sterile.
This document describes the premarket notification for the ResMed Swift™ Air nasal mask. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Predicate Device(s) | Acceptance Criteria | Reported Device Performance (Swift™ Air) |
|---|---|---|---|
| Intended Use | Mirage FX (K102746) | Identical intended use as the predicate device, for use with Positive Air Pressure therapy equipment and the same patient population. | Identical intended uses: Channels airflow noninvasively to a patient from a PAP device (CPAP or bilevel), for patients > 66 lb/30 kg, single-patient re-use in home, multi-patient re-use in hospital/institutional environment. |
| Biocompatibility | Swift™ FX (K090244) | All materials used in the construction must be deemed as safe as those of the predicate devices, in accordance with FDA Guidance #G95-1 and ISO 10993-1. Specific tests for heated humidified gas pathway (ISO 10993-3, -5, -6, -10) and skin contact (ISO 10993-5, -10). | All materials used in the construction of the new mask are deemed as safe as those of the predicate devices. Appropriate biological tests (ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, ISO 10993-10 Sensitization for heated gas pathway; ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation for skin contact) were conducted and passed. |
| CO2 Performance (Venting) | Ultra Mirage II (K050359) | Adequate venting to flush out expired CO2, satisfying predefined pass/fail criteria and being substantially equivalent to the predicate device. | CO2 performance of the new device (both vent types) was tested, including physical and functional dead-space measurements. The device satisfied all predefined pass/fail criteria and was shown to be substantially equivalent to the predicate Ultra Mirage II. |
| Pressure-Flow Characteristics & Flow Impedance | Swift™ FX (K090244) | Identical pressure-flow characteristics and flow impedance to the predicate device, operating on the same ResMed flow generator settings. | Pressure-flow and through impedance bench test results of the new mask were substantially equivalent to the predicate Swift FX. |
| Mechanical Integrity & Performance | (General Safety) | Withstand simulated normal use and reasonable abuse scenarios, and the effects of storage temperature, humidity, and transportation shock & vibration. | Mechanical integrity and performance were tested to simulated normal use and reasonable abuse scenarios. The device was tested to demonstrate it can withstand storage temperature, humidity, and transportation shock & vibration. Device development complies with ISO 14971:2007 (risk management). |
| Cleaning and Reuse | (General Safety) | Device can be safely reused (single-patient home, multi-patient hospital) following validated disinfection protocols, and function as intended after specified cleaning/disinfection cycles. | Validation of cleaning and reuse was completed. After 20 cycles of cleaning/disinfection in accordance with described methods, the device was shown to function as intended. The device satisfied pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The review document does not specify a "test set" in the context of clinical data for performance evaluation of the Swift™ Air mask. The evaluation relied heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence.
- Clinical Data: "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate substantial equivalence to the predicate devices." This indicates no new clinical studies with a specific patient "test set" were conducted for the Swift™ Air for this submission.
- Bench Testing: The sample sizes for the various bench tests (CO2 performance, pressure-flow, mechanical integrity, cleaning/reuse) are not explicitly stated in the provided text. The data provenance is presumed to be internal laboratory testing conducted by ResMed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, the evaluation was based on bench testing and comparison to predicate devices, not on expert-adjudicated clinical patient data or specific "ground truth" established by experts for a test set.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not performed. This device is a medical accessory, and its effectiveness is determined by its physical and functional characteristics in delivering CPAP/Bilevel therapy, rather than diagnostic interpretation requiring human readers.
6. Standalone Performance Study (Algorithm only without Human-in-the-Loop Performance)
Yes, implicitly. The performance data presented (CO2, pressure-flow, mechanical integrity, cleaning/reuse) represents the "standalone" performance of the device itself, under bench test conditions. This is the equivalent of "algorithm only" in the context of a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the Swift™ Air device in this submission was established by:
- Predicate Device Performance: The primary "ground truth" was the established performance and safety profiles of the predicate devices (Mirage FX, Swift™ FX, Ultra Mirage II) that have already been cleared by the FDA.
- Industry and Regulatory Standards: Adherence to standards such as FDA Guidance #G95-1, ISO 10993-1 (Biocompatibility), ISO 14971:2007 (Risk Management), and ISO 5356-1:2004 (Conical Connectors) served as additional "ground truth" for safety and performance requirements.
- Predefined Pass/Fail Criteria: For the bench tests (e.g., CO2 performance, mechanical integrity), "predefined pass/fail criteria" were used as the immediate ground truth, though these criteria would have been derived from relevant standards and predicate performance.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of this device. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
§ 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).