(156 days)
The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment
The AirFit N20 is an externally placed vented respiratory mask covering the patient's nose. It provides a seal such that pressure from a positive air pressure (PAP) source is directed to the patient's airway non-invasively via the nose. The mask connects to the positive pressure source through a conventional air tubing via a standard conical connector. The mask is held in place with adjustable head straps.
The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. The cushion and headgear are available in various sizes to fit a wide patient population.
The AirFit N20 is a prescription device supplied non-sterile.
This document is a 510(k) premarket notification for the ResMed AirFit N20, a vented nasal mask, seeking clearance for expanded reprocessing claims. It is an FDA regulatory submission, not a study report describing an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be provided as the document does not pertain to such a device.
The document discusses the substantial equivalence of the AirFit N20 with added reprocessing claims to a previously cleared predicate device. It details non-clinical testing performed to demonstrate that the expanded reprocessing claims do not affect the intended performance or raise new questions of safety or effectiveness.
Here's a breakdown of the non-clinical testing mentioned, which serves as the "study" demonstrating the device meets its expanded claims, though it is not an AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (related to expanded reprocessing claims) | Reported Device Performance (after expanded reprocessing) |
|---|---|
| Bioburden Efficacy: Cleaning and microbicidal efficacy must be maintained. | The device meets the same cleaning and microbicidal bioburden efficacy performance as the predicate device. |
| Performance Specifications: Maintain original performance specifications (Mask Pressure-Flow, mechanical integrity). | The device continues to meet the same performance specifications as the predicate device. This included: |
- Mask Pressure-Flow tests per ISO 17510:2015.
- Relevant mask mechanical integrity tests: visual inspection, assembly integrity, headgear connection integrity, simulated body weight crush test, and free fall drop test. |
| Residual Toxicity: Device must remain safe after reprocessing. | Demonstrated using appropriate Cytotoxicity biocompatibility tests, performed in accordance with ISO 10993-5:2009. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of devices/units tested. The document refers to "the subject device" implying a representative sample was used for the non-clinical tests.
- Data Provenance: The tests were conducted internally or by contracted labs as part of the regulatory submission process by ResMed Ltd. (Australia) for their device. This is prospective testing for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This is not applicable as this is not an AI/ML device study. Ground truth in this context would refer to established standards and test methods (e.g., ISO standards, biocompatibility protocols) against which the physical device performance is measured. The "experts" would be the engineers, scientists, and technicians conducting and interpreting these non-clinical tests. Their specific numbers and qualifications are not provided in this regulatory summary.
4. Adjudication Method for the Test Set:
- Not applicable as this is not an AI/ML device study. Decisions are based on objective measurements against predefined acceptance criteria from international standards (e.g., ISO 17510:2015, ISO 10993-5:2009).
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
- Established
standards and validated test methods:- Bioburden efficacy test protocols (implicitly following relevant standards for cleanliness and disinfection).
- ISO 17510:2015 for Mask Pressure-Flow tests.
- Specific mechanical integrity test protocols (visual inspection, assembly integrity, etc.).
- ISO 10993-5:2009 for Cytotoxicity biocompatibility tests.
- The ground truth is the performance of the predicate device and the specified limits/requirements within the applicable standards.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This is not an AI/ML 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).