(79 days)
The C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level therapy. The mask is reusable and for single patient use only. It is intended for adult patients in a home or hospital/institutional environment.
The C2 Nasal Mask consists of a tubular mask body, nasal interface cradle with cushion, two nasal interface cradle adapters, two exhalation devices, elbow with swivel, single split strap headgear, headgear clips and cloth cover. Standard 22 mm flexible tubing provided with a CPAP or Bi-level device connects to the mask at the elbow with swivel. The headgear provided with the mask is a single strap that splits to wrap around the top and back portions of the user's head. Velcro tabs at each end of the headgear are used to secure a clip that is used to fasten the headgear to the mask body. To remove the mask from the user's face, the user may slide the stretchable headgear over their head, unfasten the Velcro tabs and slide the straps through the clips that are attached to the mask, or release a clip from the mask body.
The provided text is a 510(k) summary for the C2 Nasal Mask, which is a medical device. This document focuses on the regulatory submission and substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria for a new or novel device feature.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Design verification tests" mentioned refer to internal product development testing to ensure the device meets its own design requirements and risk analysis, not necessarily a performance study against specific, publicly reported acceptance criteria for AI or diagnostic accuracy as typically seen in device submissions for software or imaging analysis.
The relevant sections from the document indicate:
- Premarket Notification 510(k) Section 9 - 510(K) Summary: States general information about the device and its predicate.
- Substantial Equivalence: "Design verification tests were performed on the C2 Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This statement confirms tests were done and met criteria, but does not provide the specifics of those criteria or results.
- Intended Use/Indications for Use: Describes what the mask is for.
- Device Description: Details the components of the mask.
In summary, this 510(k) submission details the regulatory approval process for a physical medical device (nasal mask), focusing on its substantial equivalence to a predicate device. It does not provide the kind of performance study data or acceptance criteria that would be relevant for a software-based or AI-driven diagnostic 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).