(28 days)
The Mirage Micro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Micro is:
- to be used by adult patients (>66lb / >30kg) 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 headgear colour of the modified device has changed. The color of the outer layer of the fabric is being changed from dark blue to tan. All other aspects of the device remain unchanged.
The modified Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labelling provided with the product.
The modified Mirage Micro is a prescription device supplied nonsterile.
Both the masks incorporate vent holes to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks. Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004)
Both masks have provisions for connecting oxygen and pressure sensing tubing via luer ports.
Both masks are constructed using molded plastic components and fabric headgear. All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1).
Both the modified device and the previously cleared device can be reused in the hospital / institution environment.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Same intended use as the predicate device (Mirage Micro Mask K072940). | The modified Mirage Micro has the same intended use: channeling airflow non-invasively to adult patients from a positive airway pressure device (CPAP or bilevel system), for single-patient re-use at home and multi-patient re-use in hospital/institutional environments. |
| Similar technological characteristics to the predicate device. | The only change is the headgear color (from dark blue to tan). All other aspects (vent holes, connectors, provisions for oxygen/pressure sensing, construction materials, re-use capability) remain identical to the predicate device. |
| Does not raise new questions of safety and effectiveness. | The change in headgear color is asserted not to affect technological characteristics when used with a compatible ResMed flow generator, and the outer layer of the fabric does not come into contact with the patient, therefore not requiring ISO 10993-1. This implies no new safety or effectiveness concerns. |
| At least as safe and effective as the previously cleared Mirage Micro (K072940). | Due to the cosmetic nature of the change (headgear color) and the assertion that it does not affect the device's function or patient contact, the device is considered substantially equivalent in safety and effectiveness to the predicate. |
| Bench testing not required as the change has no effect on technological characteristics when used with a compatible ResMed flow generator. | No bench testing was performed due to the nature of the change. This implicitly serves as an acceptance criterion being met by the product's unchanged functional aspects. |
| The headgear color change (from dark blue to tan) does not affect performance. | The document states, "The headgear colour of the modified device has changed... All other aspects of the device remain unchanged." and "The headgear performance of the modified device and the previously cleared device are substantially equivalent." This indicates the color change did not impact performance. |
| All components are fabricated using materials deemed safe (ref: ISO 10993-1). | "All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." This implies that while the outer layer of the headgear fabric doesn't come into patient contact, other components still adhere to this standard, ensuring overall safety. |
| Design of vent-holes does not interfere with the intended performance of the masks. | "Both the masks incorporate vent holes to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks." This characteristic is maintained from the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document is for a Special 510(k) for a minor device modification (headgear color change). No new clinical or performance test data was generated with a specific test set. The submission relies on a comparison to the predicate device and the assertion that the change is cosmetic and does not impact performance.
- Data Provenance: Not applicable for a new test set. The basis for substantial equivalence is the prior clearance of the predicate device (Mirage Micro Mask K072940) and the established safety and effectiveness of vented nasal masks with CPAP/Bilevel therapy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new ground truth was established for a test set as part of this Special 510(k) submission.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication was used.
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:
- No. This device is a passive medical device (a mask); it does not involve AI or human readers for interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a passive medical device and does not involve any algorithms or software-driven performance that would require standalone testing.
7. The type of ground truth used:
- The ground truth for the safety and effectiveness of the device is based on the prior clearance and established performance of the predicate device (Mirage Micro Mask K072940). The current submission argues that the modified device is substantially equivalent because the change is purely cosmetic (headgear color) and does not alter the fundamental design, materials, or intended use that were proven safe and effective by the predicate.
8. The sample size for the training set:
- Not applicable. This device is a passive medical device, and this submission is for a minor modification. It does not involve machine learning or AI, and therefore no training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set involved, no ground truth needed to be established for it.
§ 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).