(122 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 modified ResMed AirFit N20 is a non-invasive vented respiratory mask that provides a silicone air seal around the patient's nose and upper lip. The mask is held in place with adjustable head straps. Air flow from a positive air pressure (PAP) source is directed to the patient's airway non-invasively. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel.
The modified AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. For home use, the mask may be cleaned in warm soapy water.
The AirFit N20 is a prescription device supplied non-sterile.
This document describes the regulatory submission for the ResMed AirFit N20, a non-invasive vented respiratory mask. The submission, K161978, is a modification of a previously cleared predicate device, AirFit N20 (K153673), aiming to demonstrate substantial equivalence.
Based on the provided information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance: | ||
| CO2 rebreathing | Demonstrated to be in accordance with ISO 17510:2015. (Implied: Acceptable CO2 levels, comparable to predicate) | Verified to meet predetermined acceptance criteria and substantially equivalent to predicate. |
| Total mask flow | Demonstrated to be in accordance with ISO 17510:2015. (Implied: Flow characteristics comparable to predicate) | Verified to meet predetermined acceptance criteria and substantially equivalent to predicate. |
| Flow resistance | Demonstrated to be in accordance with ISO 17510:2015. (Implied: Resistance characteristics comparable to predicate) ----------------------------------------------------------- | Verified to meet predetermined acceptance criteria and substantially equivalent to predicate. |
| Through impedance | Demonstrated to be in accordance with ISO 17510:2015. (Implied: Impedance characteristics comparable to predicate) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Verified to meet predetermined acceptance criteria and substantially equivalent to predicate. |
| Operating pressure range | Similar to predicate | Similar performance to predicate. |
| Pressure flow | Similar to predicate | Similar performance to predicate. |
| Flow impedance characteristics | Similar to predicate | Similar performance to predicate. |
| PAP device settings ("Pillows, Mirage or Swift") | Operate on the same ResMed flow generator settings as predicate ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Operates on the same settings as predicate. |
| Mechanical Integrity: | ||
| Home cleaning for single patient reuse | Verified under simulated normal use and reasonable abuse scenarios. (Implied: Maintains integrity and function after home cleaning) | Verification confirmed it met predetermined acceptance criteria. |
| Reprocessing for multi-patient reuse | Verification under simulated normal use and reasonable abuse scenarios, including cleaning efficacy, disinfection efficacy, post-disinfection/sterilization performance, and residual toxicity evaluation. (Implied: Maintains integrity and function, remains safe for multi-patient reuse after reprocessing) | Verification confirmed it met predetermined acceptance criteria. |
| Transportation | Verified under simulated normal use and reasonable abuse scenarios. (Implied: Withstands transportation without damage or loss of function) | Verification confirmed it met predetermined acceptance criteria. |
| Storage | Verified under simulated normal use and reasonable abuse scenarios. (Implied: Maintains integrity and function during storage) | Verification confirmed it met predetermined acceptance criteria. |
| Biocompatibility: | In accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 for modified components using new materials with patient exposure classifications of permanent external communicating device (tissue) and/or permanent skin contact. (Implied: No unacceptable biological risks) | Evaluation conducted, relying on predication for components with previously cleared materials. |
| Material Specifications: | Use of polymeric construction materials for pneumatic and structural components and foam padded fabrics for the head strap. ISO 5356-1 compliant 22mm diameter swivel for connection to PAP delivery hose. | Similar to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific tests (e.g., number of masks tested for CO2 rebreathing, or number of cleaning/reprocessing cycles). It mentions "testing to simulated normal use and reasonable abuse scenarios," suggesting laboratory-based testing.
- Data Provenance: The testing was conducted by ResMed Ltd, an Australian company, for a device intended for international markets (indicated by FDA submission). The data is retrospective in the sense that it's bench testing and verification/validation conducted by the manufacturer, not a prospective clinical trial. There is no mention of data from human subjects in the testing phase beyond what is implicitly covered by biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device submission primarily relying on bench testing and engineering verification/validation against international standards (e.g., ISO 17510:2015, ISO 10993 series) and comparison to a predicate device, rather than human expert-established ground truth for a diagnostic output. The "ground truth" here is the adherence to established engineering specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable for this type of submission. The evaluation is based on objective measurements against pre-defined engineering and performance criteria and adherence to recognized standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document explicitly states: "Clinical data was not relied upon to demonstrate Substantial Equivalence to the predicate device. Bench testing demonstrates that the modified AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the previously cleared predicate AirFit N20 device (K153673)." Therefore, an MRMC study is not relevant to this submission.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
Yes, in the sense that the device's functional and mechanical performance was evaluated in isolation ("bench testing") against pre-defined specifications and standards. This is not an AI algorithm, but a physical medical device; its "standalone performance" refers to its intrinsic characteristics and operation.
7. Type of Ground Truth Used
The "ground truth" for this device, as described in the submission, is based on:
- International Standards: Primarily ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy Masks and application accessories) and ISO 10993 series for biocompatibility.
- Engineering Specifications: Predetermined acceptance criteria derived from the device's design requirements and performance characteristics of the legally marketed predicate device (K153673).
- Predicate Device Performance: The original AirFit N20 (K153673) serves as a benchmark for "similar performance."
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no AI/ML training set.
§ 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).