(85 days)
The Swift LT channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift LT 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 LT 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 LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Swift LT is a prescription device supplied nonsterile.
The document describes the 510(k) summary for the ResMed Swift™ LT nasal mask, a medical device for channeling airflow from a positive airway pressure device to a patient. The submission asserts substantial equivalence to predicate devices (Mirage Swift and Ultra Mirage II Mask) rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not directly applicable or available from the provided text.
The submission states: "Bench testing is sufficient to demonstrate safety and efficacy of the Swift LT, as was the case with the predicate device." This indicates that the regulatory pathway relies on demonstrating performance comparable to existing, legally marketed devices through bench testing, rather than an independent clinical study against predefined acceptance criteria for novel performance.
However, based on the provided text, we can infer the basis for demonstrating substantial equivalence, which acts as the de facto "acceptance criteria" here:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no explicit "acceptance criteria" for a novel device performance study are presented, the "acceptance criteria" for this 510(k) submission are based on demonstrating "substantial equivalence" to the predicate devices. The reported device performance is presented as a comparison to these predicates.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as compared to predicates) |
|---|---|
| Same/Reworded Intended Use | Swift LT has the same, though reworded, intended use as the predicate devices. (Intended Use: channels airflow noninvasively from a positive airway pressure device to adult patients (> 66 lb/30 kg); for single-patient re-use in home, multi-patient re-use in hospital/institutional environment.) |
| Similar Technological Characteristics | Seal Interface: New device and predicates provide a seal via silicone interface; offered in various sizes. |
| Vent Holes: Both incorporate vent holes for continuous air leak to minimize CO2 rebreathing; design does not interfere with performance. | |
| Connectors: Both connect to conventional air delivery hoses via standard conical connectors (ISO 5356-1:2004). | |
| Materials: Both constructed using molded plastic, silicone components, and fabric/nylon headgear; all materials deemed safe (ISO 10993-1). | |
| Operation with Flow Generators: Both designed to operate on the same ResMed flow generator settings (Mirage or Swift). | |
| Pressure-flow characteristics and flow impedance: Substantially equivalent to predicate devices. | |
| CO2 performance: Substantially equivalent to predicate Ultra Mirage II. | |
| Reuse: Both can be reused in home and hospital/institution environment. | |
| No New Questions of Safety and Effectiveness | The submission explicitly states "it does not raise new questions of safety and effectiveness." The differences are in the number of components, design/geometry, and component interface. |
| At least as Safe and Effective as Predicates | The submission explicitly states "it is at least as safe and effective as the predicate devices Mirage Swift and Ultra Mirage II." Bench testing was deemed sufficient for this demonstration. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission relies on "bench testing" and comparison of technological characteristics rather than a clinical "test set" with human subjects to evaluate new performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No patient-level test set requiring expert ground truth was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No patient-level test set requiring adjudication was described.
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:
- Not applicable. This device is a medical mask for positive airway pressure therapy, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a mechanical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / No direct "ground truth" as described for a clinical study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, against which the new device's characteristics and performance (e.g., CO2 performance, pressure-flow characteristics) were compared via bench testing.
8. The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable / Not provided. (See point 8)
§ 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).