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510(k) Data Aggregation
(95 days)
The AirFit™ N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit™ N10 is:
to be used by patients (> 66 lb/30 kg) 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 AirFit™ N10 is an externally worn mask that provides an air seal, such that air flow from a positive pressure source is directed to the patient's nose. The mask is held in place with an adjustable headgear. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel. The mask may be cleaned with mild soap.
continuous air leak to prevent rebreathing of dead space CO2
AirFit™ N10 is a prescription device supplied non-sterile.
Here's an analysis of the provided text regarding the AirFit™ N10 Traditional 510(k) submission, focusing on the acceptance criteria and the study used to demonstrate equivalence.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against strict, novel acceptance criteria in a clinical study. Therefore, some of the requested information (especially for AI/ML device evaluations like MRMC studies, specific expert qualifications for ground truth, and separate training/test sets with large sample sizes) is not applicable or directly available in this type of submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench/Non-clinical Tests) | Reported Device Performance (Satisfied/Equivalent) |
|---|---|
| CO2 Washout Performance: Ensure adequate venting to flush out expired CO2, including physical and functional dead-space measurements. | Satisfied: "The device satisfied all predefined" (implicitly, the CO2 washout requirements) and was found to be substantially equivalent to the predicate Ultra Mirage II device (K050359). |
| Pressure Flow and Flow Impedance: Equivalent to predicate devices. | Substantially Equivalent: "Pressure-flow and through impedance bench test results of the new mask were also substantially equivalent to the predicate Swift FX Nano device (K123789)." |
| Mechanical Integrity Performance: Withstand simulated normal use and reasonable abuse scenarios, storage temperature, humidity, and transportation shock & vibration. | Satisfied: "Mechanical integrity performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration." "The device satisfied the pass/fail criteria." |
| Cleaning and Reuse (Single/Multi-patient): Function as intended after validated disinfection protocols (e.g., 20 cycles). | Satisfied: "Validation of cleaning and reuse was completed... After 20 cycles of cleaning/disinfection... the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices." |
| Biocompatibility (Path of heated humidified gas pathway - permanent external communicating devices): Adherence to ISO 10993-1 for Genotoxicity, Cytotoxicity, Implantation, and Sensitization. | Passed: "The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were: ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation and ISO 10993-10 Sensitization." |
| Biocompatibility (Permanent skin contact components): Adherence to ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. | Passed: "The appropriate biological tests conducted and passed for components considered to be in permanent skin contact, in accordance with FDA guidance #G95-1, were: ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation." |
| Risk Management: Compliance with ISO 14971:2007. | Complied: "development of the AirFit™ N10 device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical data for performance evaluation. The evidence is based on bench testing of the device itself, rather than a dataset of patient cases. For the cleaning/disinfection tests, the testing involved a single device (or set of components) undergoing 20 cycles. Biocompatibility tests would involve material samples.
- Data Provenance: The data is from bench testing conducted by ResMed Ltd. The country of origin for the testing itself is not specified but would presumably be associated with the manufacturer's R&D facilities. This is a prospective assessment of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This device is a physical mask, and the evaluation is based on objective, quantifiable physical and material properties (CO2 washout, pressure-flow, mechanical integrity, biocompatibility). Clinical "ground truth" established by experts in the typical sense for AI/ML devices is not relevant here. The evaluation relies on established engineering and material science standards.
4. Adjudication Method for the Test Set
- Not Applicable: There was no "adjudication" of expert opinions for a test set as this was not an AI/ML device or a clinical observational study requiring such consensus. The acceptance criteria are based on objective pass/fail thresholds for physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No: No MRMC comparative effectiveness study was done. This type of study focuses on human reader performance with and without AI assistance, which is irrelevant for a physical CPAP mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable: This is not an algorithm or software device. The "standalone" performance refers to the device's physical function as outlined in the bench tests.
7. The Type of Ground Truth Used
- For the physical/material tests, the "ground truth" aligns with:
- Objective Measurement Standards: e.g., defined CO2 levels, pressure differentials, physical integrity thresholds, and chemical properties for biocompatibility.
- Comparative Equivalence: Demonstrating that the device performs "substantially equivalent" to predicate devices as measured by these objective standards.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of an AI/ML algorithm for this physical device submission. The design and development of the device would involve iterative testing and refinement, but this is distinct from "training data" for a machine learning model.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there's no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" during device development (design, prototyping, and early testing) would be based on engineering specifications, user needs, and established medical device standards.
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