(70 days)
The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX is: to be used by adult 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 FX provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Swift FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Swift FX is a prescription device supplied nonsterile.
This document describes a 510(k) premarket notification for a medical device called Swift™ FX, a vented nasal mask. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study against specific acceptance criteria for a novel device. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.
Analysis of the Provided Text for Acceptance Criteria and Study Information:
The document is a 510(k) summary, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It primarily relies on comparisons to existing devices and bench testing, rather than extensive clinical trials with specific acceptance criteria as might be seen for a novel, high-risk device.
Here's an breakdown based on your request, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't outline specific, quantitative acceptance criteria in a table format with corresponding numerical performance results for the Swift™ FX. Instead, it asserts "substantial equivalence" based on various characteristics:
| Feature/Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Swift™ FX) |
|---|---|---|
| Intended Use | Same as predicate devices (Swift LT, Ultra Mirage II) | Channels airflow noninvasively to a patient from a PAP device; for adult patients (> 66 lb/30 kg); single-patient re-use in home, multi-patient re-use in hospital/institutional environment. Meets criteria by being "the same." |
| Technological Characteristics | Similar to predicate devices | Provides a seal via silicone interface; offered in various sizes; incorporates vent holes for continuous air leak; connects to conventional air delivery hose via standard conical connectors; constructed using molded plastic, silicone, and fabric/nylon headgear; components fabricated using materials deemed safe (ref: ISO 10993-1). |
| Material Safety | Materials deemed safe (ref: ISO 10993-1) | All components fabricated using materials deemed safe. Meets criteria. |
| Flow Generator Settings | Operates on same Mirage or Swift ResMed flow generator settings as predicate | New device and predicate are designed to operate on the same Mirage or Swift ResMed flow generator settings. Meets criteria. |
| Pressure-Flow Characteristics & Flow Impedance | Substantially equivalent to predicate devices | Both new device and predicate device are substantially equivalent. Meets criteria. |
| CO2 Performance | Substantially equivalent to predicate Ultra Mirage II | The CO2 performance of the new device and the predicate device are substantially equivalent. Meets criteria. |
| Reusability | Reusable in home and hospital/institution environment | New device and predicate device can be reused in the home and hospital/institution environment. Meets criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states: "Bench testing is sufficient to demonstrate safety and efficacy of the Swift FX, as was the case with the predicate device."
- Sample Size: Not specified. "Bench testing" typically refers to laboratory simulations and does not involve human subjects in a "test set" in the way clinical studies do. The number of masks or components tested is not mentioned.
- Data Provenance: The data primarily comes from bench testing conducted by ResMed. There is no mention of country of origin for the data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable/Not provided. The "ground truth" in this context is established through engineering and performance specifications during bench testing by the manufacturer, comparing the new device against the known performance of predicate devices. There is no mention of independent "experts" adjudicating clinical data for a test set.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. Since there's no "test set" in the clinical sense needing adjudication, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images. The Swift™ FX is a respiratory mask, and its assessment does not involve human readers interpreting "cases" in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The Swift™ FX is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. Its performance is inherent in its design and physical characteristics.
7. The Type of Ground Truth Used:
- The "ground truth" for the Swift™ FX's performance is essentially the engineering specifications and established performance characteristics of the predicate devices (Swift LT and Ultra Mirage II). The new device is considered "safe and effective enough" if its bench test results are "substantially equivalent" to these known and accepted predicate devices. This falls under engineering/performance data comparison rather than pathology or outcomes data.
8. The Sample Size for the Training Set:
- Not applicable. As a physical medical device, the Swift™ FX does not involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing process are guided by engineering principles and quality management systems (ResMed's 21 CFR Part 820 compliant Quality Management System).
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.
§ 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).