(154 days)
The Darlinghurst Vented mask is a non-invasive accessory used for channeling airflow to a patient from positive airway pressure (PAP) devices.
The mask is:
- to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure therapy has been prescribed
- disposable devices, intended for short-term treatment (up to 7 days) of a single patient, in the hospital environment only.
The Darlinghurst NV-AAV mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device.
The mask is:
- to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure ● therapy has been prescribed
- a disposable device, intended for short-term treatment (up to 7 days) of a single patient, in the ● hospital environment only
- intended to be used with breathing circuits or positive pressure ventilation (PPV) devices that provide their own method of venting expired or supplemental gases.
The Darlinghurst masks are externally placed masks covering the mouth and the nose of the patient. They provide a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. The masks connect via a standard (female ISO5356-1) conical connector to a conventional air delivery hose between the mask elbow and the positive airway-pressure source.
They are held in place with a common adjustable headgear that straps the mask to the face.
Darlinghurst masks are disposable devices that can be used for a maximum period of 7 days, on a single-patient and in the hospital/institutional environment only.
Both Darlinghurstmask variants are very similar in design and function. The only difference between the Darlinghurst 'Vented' and the Darlinghurst 'NV-AAV' is in the elbow component.
Whilst both variants of the mask include a built-in Anti-Asphyxia Valve (AAV) to allow the patient to continue to breathe fresh air in the event of a positive air-pressure supply failure or impediment,
- . The Darlinghurst Vented mask includes additional built-in diffuse exhaust ports to provide a continuous air leak that flushes out CO2 and prevent it from being rebreathed by the patient
- The Darlinghurst NV-AAV design does not incorporate built-in passive exhaust ● ports. This non-vented variant of the mask requires a separate part of the breathing circuit (e.g. an active exhaust valve in the ventilator or an additional leak valve) to vent the expired air (including CO2).
All other components of the masks are common to both Darlinghurst variants.
Darlinghurst masks are intended to be used under the conditions and purposes indicated in the labelling provided with the product.
Darlinghurst masks are prescription devices, supplied non-sterile.
The provided document describes the FDA 510(k) clearance for the ResMed Darlinghurst Vented and Darlinghurst NV-AAV masks, which are non-invasive accessories for positive airway pressure (PAP) devices.
1. Table of acceptance criteria and the reported device performance:
The document presents a table summarizing various bench tests conducted and their corresponding pass/fail results. While explicit acceptance criteria (numerical thresholds) are not fully detailed for each test, the general acceptance criterion is that the device "PASS"es the test, implying it meets predefined performance targets.
| Bench Test Category | Test Name | Darlinghurst NV-AAV Performance | Darlinghurst Vented Performance |
|---|---|---|---|
| CO2 Flushing | Functional dead-space measurements normal use | N/A (Not Applicable) | PASS |
| Functional dead-space measurements Single fault condition | PASS | PASS | |
| Physical dead-space measurement | PASS | PASS | |
| AAV Performance | Activation (Open to Atmosphere) | PASS | PASS |
| Deactivation (Close to Atmosphere) | PASS | PASS | |
| Inspiratory resistance | PASS | PASS | |
| Expiratory resistance | PASS | PASS | |
| Inadvertent activation | PASS | PASS | |
| Inadvertent de-activation | PASS | PASS | |
| AAV Durability | PASS | PASS | |
| Mask Characteristics | Pressure-flow test - Total mask flow | N/A (Not Applicable) | PASS |
| Pressure-flow test - Un-intentional leak | PASS | N/A (Not Applicable) | |
| Mask Impedance | PASS | PASS | |
| Assembly Integrity (post cleaning) | Normal use | PASS | PASS |
| Reasonable abuse | PASS | PASS | |
| Pressure-flow test (post cleaning) | PASS | PASS | |
| AAV Activation/De-activation (post cleaning) | PASS | PASS | |
| Ease of Cleaning | Ease of cleaning - geometry accessibility | PASS | PASS |
| Material Safety | Biocompatibility of all mask components (ref: ISO 10993-1) | PASS | PASS |
| Transportation and Storage | Performance after storage under simulated extreme environmental conditions | PASS | PASS |
| Performance after shock and vibration simulating extreme transportation environment | PASS | PASS |
The report states that the characteristics listed above ensure that clinicians are able to prescribe the appropriate therapy when using the new device. The CO2 performance data demonstrates re-breathing to be substantially equivalent to the predicates.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a specific "sample size" in terms of number of individuals or devices for each test. Instead, it refers to "bench testing" which typically involves testing of representative samples of the device. The data provenance is implied to be from laboratory testing performed by ResMed Ltd, an Australian company, as part of their 510(k) submission. The exact country of origin of the data is not specified beyond the manufacturer's location. The studies are retrospective in the sense that they are conducted on manufactured devices in a laboratory setting to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The "ground truth" in this context refers to established technical standards and the performance of predicate devices, which are assessed through objective laboratory measurements rather than expert human interpretation of medical images or conditions. The study is a comparison to a predicate device and relevant industry standards (e.g., ISO 17510-2:2007 for CO2 performance, ISO 10993-1 for biocompatibility).
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human interpretation or diagnosis is involved. Here, the tests are objective bench tests with pass/fail outcomes against established technical criteria or comparison to a predicate device.
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:
This information is not applicable. The device is a medical mask and not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical mask, not an algorithm.
7. The type of ground truth used:
The "ground truth" used for assessing the device's performance relies on several factors:
- Established technical standards: Such as ISO 17510-2:2007 for CO2 re-breathing and ISO 10993-1 for biocompatibility.
- Performance of predicate devices: The Darlinghurst masks were compared against the Hans Rudolph 6600 Series V2 (for Vented) and Hans Rudolph 6700 Series V2 (for NV-AAV). The established performance characteristics of these predicate devices served as a benchmark for substantial equivalence.
- Engineering specifications and design requirements: The "PASS" results indicate that the device met its predefined engineering specifications derived from relevant standards and predicate device performance.
8. The sample size for the training set:
This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set. The development of the masks likely involved iterative design and testing, but not in the context of "training data."
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 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).