(56 days)
The Hospital Full Face Mask is intended for single patient use for adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy in hospitals or clinics. This is a disposable mask. It is intended to be used for the short-term (maximum 7 days) treatment of a single patient only, then discarded.
The Hospital Full Face Mask is a respirator mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bilevel devices. The Hospital Full Face Mask is strapped to the patient's face covering the nose and mouth. It is connected via tubing to a CPAP or bilevel flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way. The Hospital Full Face Mask comes in 3 sizes, small, medium and large. Each size comprises a frame, cushion and cushion clip.
This 510(k) summary describes a premarket notification for the ResMed Hospital Full Face Mask, a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Mirage Full Face Mask Series 2.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific leakage rates, pressure limits, material degradation percentages) that the new device needed to meet. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device, the Mirage Full Face Mask Series 2.
The "Performance Data" section states: "Testing is provided to demonstrate that the Hospital Full Face mask is substantially equivalent to the Full Face Mask series 2. The original testing that was performed for the Full Face Mask Series 2 was reviewed as an input to the selected test methods."
Therefore, the reported device performance is that the ResMed Hospital Full Face Mask performs substantially equivalently to the Mirage Full Face Mask Series 2.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device (K023244) in terms of: | "The Hospital Full Face Mask is substantially equivalent to the Mirage Full Face Mask Series 2." |
| - Intended use | Similar intended use, with the Hospital mask being single patient use only for short-term. |
| - Operating principle | Same operating principle (strapped to face, connected to CPAP/bilevel to apply positive pressure). |
| - Technological characteristics | Same technological characteristics (comes in 3 sizes, comprises frame, cushion, clip). |
| - Manufacturing process | Same manufacturing process. |
| Biocompatibility of materials | Materials are either predicate, comply with ISO10993-1, or were tested for conformance to ISO10993-1. |
| Not affecting safety and effectiveness of the device | "The changes in design do not affect safety and effectiveness of the Hospital Full Face Mask." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any performance testing. It mentions "Testing is provided to demonstrate that the Hospital Full Face mask is substantially equivalent" and refers to "the original testing that was performed for the Full Face Mask Series 2."
- Test Set Sample Size: Not specified.
- Data Provenance: Not explicitly stated as "country of origin." The submitter is ResMed Ltd, located in Australia, but the testing itself might have occurred elsewhere. The reference to "ResMed's state of the art knowledge and procedures" suggests internal company testing. It is a retrospective review of testing previously performed for the predicate device, along with new testing for the current device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this type of device submission. The submission is for a physical medical device (mask interface), not an AI/ML algorithm that requires expert-established ground truth for classification or prediction. The "ground truth" here is the performance characteristics of the predicate device and the new device's ability to meet those.
4. Adjudication Method for the Test Set:
This information is not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or for establishing ground truth in AI/ML performance evaluations involving human interpretation. For a physical device, performance is evaluated against engineering and usability standards.
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 full face mask, not an AI or imaging diagnostic tool that would involve human readers or AI assistance for interpretation.
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 device; it does not involve algorithms or AI.
7. The Type of Ground Truth Used:
The primary "ground truth" used for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Mirage Full Face Mask Series 2). The new device's performance is compared against the known and accepted performance of this predicate. Additionally, ISO10993-1 standards serve as a ground truth for biocompatibility.
8. The Sample Size for the Training Set:
This information is not applicable. The device 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:
This information is not applicable. As stated above, this device does not involve a training set for an AI/ML algorithm.
§ 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).