(74 days)
The Mirage Quattro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Quattro is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.
The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.
The Mirage Quattro provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.
The Mirage Quattro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The Mirage Quattro is a prescription device supplied non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ResMed Mirage Quattro device:
ResMed Mirage Quattro - Acceptance Criteria and Study Analysis
This 510(k) summary focuses on a "Special 510(k): Device Modification" for the ResMed Mirage Quattro, comparing it to a previously cleared version (K063122). The primary modification appears to be an extended therapy pressure range.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for parameters like CO2 performance or pressure-flow characteristics. Instead, it relies on substantiating equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy Equivalence to Predicate Device (K063122) | Conclusion: "The modified Mirage Quattro is as safe and effective as the previously cleared Mirage Quattro device." |
| Identical Intended Use | "it has the same intended use" |
| Identical Technological Characteristics (overall) | "it has identical technological characteristics to the previously cleared device" (except for the extended pressure range, which was verified). This includes: sealing via silicone interface, various sizes for fit, integrated vents for CO2 flushing, anti-asphyxia valve (AAV), conventional air delivery hose connection (ISO 5356-1:2004), moulded plastic/silicone components and fabric/nylon headgear, all materials deemed safe (ISO10993-1). |
| No New Questions of Safety or Effectiveness | "the modified device did not raise any new questions of safety or effectiveness" |
| CO2 Performance Equivalence | "The CO2 performance of the modified device and the previously cleared device are substantially equivalent." |
| Pressure-Flow Characteristics and Flow Impedance Equivalence | "The pressure-flow characteristics and flow impedance of both the modified device and the predicate device are identical." |
| Operability on Same Flow Generator Settings | "Both the modified device and the previously cleared device are designed to operate on the same Full Face ResMed flow generator settings." (Note: The only difference mentioned is an extension of the therapy pressure range.) |
| Extended Therapy Pressure Range (4-20cmH2O to 4-40cmH2O) - Verified | "Verification testing of the modified device did not raise any new questions of safety and efficacy." |
| Reusability in Home and Hospital/Institution Environment | "Both the modified device and the previously cleared device can be reused in the home and hospital / institution environment." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This indicates that no clinical "test set" with human subjects was used for this modification. The testing was entirely bench-based, meaning it likely involved laboratory equipment and simulations rather than patient data.
- Sample Size for Test Set: Not applicable, as testing was bench-based.
- Data Provenance: Not applicable, as no human data was collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted. The assessment was based on engineering and performance specifications, likely evaluated by internal ResMed engineers and regulatory affairs personnel.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states, "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This rules out any clinical studies, including MRMC studies, for this particular modification.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not directly applicable in the context of a medical device like a mask, which is a physical interface and not an algorithm or AI. The testing performed would be considered "standalone" in the sense that it was bench testing of the device itself, without human interaction.
7. The Type of Ground Truth Used
The "ground truth" for this modification was primarily:
- The performance specifications and characteristics of the predicate device (Mirage Quattro K063122), which had previously demonstrated safety and efficacy.
- Engineering and performance test results (e.g., pressure-flow, CO2 flush, material safety) showing that the modified device met these specifications and performed equivalently or acceptably within the extended pressure range.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm or AI model was involved in this device modification.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning algorithm or AI model was involved.
§ 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).