(63 days)
The Quattro Air Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system.
The Quattro Air Mask System is:
- . to be used by patients (weighing >66 lb/30 kg) for whom positive airway pressure therapy has been prescribed.
- intended for single patient re-use in the home environment and multi-patient re-use in ● the hospital/institutional environment ..
The Quattro Air is an externally placed mask covering the mouth and the nose of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. It is held in place with an adjustable headgear that straps the mask to the face.
Quattro Air is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Quattro Air is a prescription device supplied non-sterile.
The Quattro Air device, a vented full face mask, underwent several non-clinical tests to demonstrate its substantial equivalence to predicate devices (Mirage Quattro, Mirage FX, and Ultra Mirage FFM). The studies focused on functional performance, mechanical integrity, cleaning validation, and biocompatibility.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| CO2 Performance | Adequate venting to flush out expired CO2 (defined by pass/fail criteria and substantial equivalence to predicate devices) | The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices through physical and functional dead-space measurements. |
| Anti-Asphyxia Valve (AAV) Performance | Ensure patient can breathe fresh air if airflow is impeded (defined by pass/fail criteria and substantial equivalence to predicate devices) | The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
| Pressure-Flow Characteristics and Through Impedance | Clinicians can prescribe appropriate therapy (defined by pass/fail criteria and substantial equivalence to predicate devices) | The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
| Mechanical Integrity and Performance | Withstand normal use, reasonable abuse, storage temperature, humidity, and transportation shock & vibration (defined by pass/fail criteria based on system specifications and FDA Guidance) | The device satisfied the specific pass/fail criteria and was shown to be substantially equivalent to the predicate devices for normal use, reasonable abuse scenarios, storage temperature, humidity, and transportation shock & vibration. |
| Cleaning Validation | Function as intended after cleaning/disinfection for single-patient and multi-patient re-use (defined by pass/fail criteria and substantial equivalence to predicate devices after 20 cycles) | After 20 cycles of cleaning/disinfection in accordance with specified methods, the device was shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
| Biocompatibility | Compliance with ISO 10993-1 for prolonged or permanent tissue contact (cytotoxicity, sensitization, irritation, genotoxicity, implantation tests as required) | All externally communicating components with either prolonged (24 hours - 30 days) or permanent (>30 days) tissue contact were validated with cytotoxicity, sensitization, irritation, genotoxicity, and implantation tests as required. Components with skin contact underwent cytotoxicity, sensitization, and irritation testing. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of masks tested for CO2 performance). It refers to "the device" in a general sense, implying that representative samples were used for each test.
The data provenance is non-clinical testing data, conducted by the manufacturer, ResMed. There is no mention of country of origin for the data or if it was retrospective or prospective, as these are typically not applicable to non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies described are non-clinical bench tests. The "ground truth" for these tests would be established by validated test methodologies, industry standards (like ISO 10993-1), and FDA guidance, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple readers.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The submission states that "bench testing is sufficient to demonstrate safety and efficacy of the new Quattro Air mask, as was the case with the predicate devices," and that "Use of vented masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community." This indicates that clinical studies involving human readers were not performed or deemed necessary.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This section is not applicable. The Quattro Air is a physical medical device (mask), not an AI algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests consisted of:
- Validated test methodologies: Standardized procedures for measuring CO2 re-breathing, AAV performance, pressure-flow characteristics, mechanical integrity, and cleaning effectiveness.
- Industry Standards: Specifically, ISO 10993-1 for biocompatibility.
- System Specifications and FDA Guidance: For mechanical integrity and performance.
- Performance of Predicate Devices: Used as a benchmark for substantial equivalence comparisons.
8. Sample Size for the Training Set
This section is not applicable. The Quattro Air is a physical device and not an AI or machine learning model. Therefore, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
§ 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).