(55 days)
The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.
Mirage FFM Series 2 is a respiratory mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bi-level devices.
The provided text describes the Mirage Full Face Mask Series 2 and its substantial equivalence to the predicate device, Mirage FFM. The primary focus of this submission is to validate the addition of a new sterilization method (Sterrad 100S System) for multi-patient use.
Here's an analysis based on the information provided, keeping in mind that this document is a 510(k) submission, which focuses on substantial equivalence rather than detailed performance studies like those for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| For High-Level Disinfection (Liquid Chemicals): | Validation performed: Mirage FFM Series 2 was validated for multiple-patient use with: |
- 3.4% glutaraldehyde solution (e.g., Cidex Plus)
- 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g., Cidex PA).
Semi-critical mask components withstand 15 cycles of high-level disinfection. (The predicate Mirage FFM was already validated for these methods, and the new device maintains this.) |
| For Sterilization (Sterrad 100S System): | Validation performed: Mirage FFM Series 2 was validated for multiple-patient use with sterilization using the Sterrad 100S System made by ASP (K991999).
Semi-critical mask components withstand 15 cycles of sterilization. |
| Functional Integrity after Disinfection/Sterilization (15 cycles): | Implied successful performance as the device is deemed "substantially equivalent" and the sterilization method "does not affect safety and effectiveness." |
| Material Compatibility after Disinfection/Sterilization: | Implied successful performance, as the materials in air-path are identical to the predicate, and new materials (headgear, port caps) are deemed compatible with the cleaning/sterilization processes. |
| Headgear (non-critical item) does not require high-level disinfection/sterilization: | The headgear is classified as a non-critical item and thus does not require high-level disinfection/sterilization, as stated. |
| Valve membrane and air tubing replacement requirement (post-disinfection/sterilization for multi-patient use): | The user instructions highlight that the valve membrane and air tubing cannot be disinfected/sterilized and must be replaced before reusing on another patient. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance or a specific patient cohort for the sterilization validation. The validation is focused on the device's ability to withstand disinfection/sterilization processes.
- Sample Size: Not explicitly stated for number of units tested or patient data. The statement "15 cycles" refers to the number of disinfection/sterilization cycles the components were subjected to.
- Data Provenance: Not applicable in the context of country of origin for clinical data, as this is a device reprocessing validation, not a clinical trial. The validation was conducted to support the 510(k) submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this submission relates to the efficacy of the disinfection/sterilization processes and the material integrity of the device components. This is typically established through laboratory testing and engineering analysis rather than expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-reviewed "test set" requiring adjudication.
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 is a medical device for respiratory therapy, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Performance Standards for Disinfection/Sterilization: The ability of the device components to withstand 15 cycles of specified high-level disinfection methods and the Sterrad 100S System sterilization method, while maintaining functionality and material integrity.
- Material Compatibility: Confirmation that the materials used are compatible with the reprocessing methods and maintain their intended properties.
- Predicate Device Equivalence: The foundation of the submission is demonstrating substantial equivalence to the predicate "Mirage FFM," which means its performance and safety characteristics, including its reprocessing capabilities, are comparable.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning for this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is generally referred to as "Performance Data" within the submission. It involves validation studies related to the reprocessing of the device for multi-patient use.
- The Mirage FFM Series 2 was subjected to 15 cycles of:
- High-level disinfection with 3.4% glutaraldehyde solution.
- High-level disinfection with 0.08% peroxyacetic acid and 1% hydrogen peroxide.
- Sterilization with the Sterrad 100S System made by ASP.
- A "conditioning cycle" for each reprocessing method included disassembly, cleaning, disinfection/sterilization, and re-assembly.
- The acceptance criterion was that the "semi-critical mask components can withstand 15 cycles" of these processes. While the specific metrics of "withstanding" (e.g., burst pressure, leakage, material degradation assessment) are not detailed in this summary, they would have been part of the underlying validation reports.
- The "performance data" effectively demonstrates that the device's semi-critical components retain their integrity and functionality after repeated reprocessing, thus supporting its suitability for multiple-patient use with these methods. The conclusion of substantial equivalence further implies that this reprocessing does not compromise the device's safety or effectiveness compared to the predicate.
§ 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).