(126 days)
The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device. The Pixi Pediatric mask is: • to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) or bilevel therapy has been prescribed • intended for single-patient re-use in the home environment and single-patient re-use in the hospital/institutional environment
The Pixi Pediatric Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. The Pixi Pediatric Mask is a prescription device supplied non-sterile. The new device provides a seal to the patient's face via a silicone elastomer interface whereas the predicate mask uses an alternative elastomer. Both the masks incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 re-breathed by the patient. The design of the mask components in the new mask is such that the incorporation of these vent-holes does not interfere with the intended performance of the mask. Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors. The new device is constructed using molded plastic and silicone components and fabric / nylon headgear. All the components are fabricated using materials deemed safe (ref: ISO 10993-1). The main differences between the new device and the predicate is in the components, their design/geometry and how individual components interface with each other.
This submission is for a medical device (Pixi™ Pediatric Mask), not an AI/ML powered device, therefore, the requested information in the prompt is not applicable. This document is a 510(k) premarket notification indicating that the device has been found substantially equivalent to a predicate device and is approved for market.
Here is a summary of the available information:
Device: Pixi™ Pediatric Mask
Predicate Device: MiniMe Pediatric Mask (K090935)
Intended Use: To channel airflow noninvasively from a CPAP or bilevel device to children aged 2-7, for single-patient re-use in home or hospital/institutional environments.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Adequate venting as demonstrated by physical and functional deadspace analysis | The mask design provides adequate venting, and CO2 performance is substantially equivalent to the predicate device. |
| Mechanical integrity during normal use and reasonable abuse scenarios | Assembly integrity testing demonstrated mechanical integrity. |
| Biocompatibility of components | Material safety testing demonstrated biocompatibility of components (ref: ISO 10993-1). |
| Cleaning, transport, and storage conditions validated | Cleaning, transport, and storage conditions were validated. |
| Pressure-flow and flow-impedance characteristics measured | Pressure-flow and flow-impedance characteristics were measured. |
2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on bench testing and substantial equivalence to a predicate device rather than clinical data from a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission relies on bench testing and substantial equivalence to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was done. The submission states that "Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For the purposes of this submission, the "ground truth" for proving safety and efficacy was established through bench testing for physical and functional performance, material safety, and mechanical integrity, and by demonstrating substantial equivalence to an already legally marketed predicate device (MiniMe Pediatric Mask). The claim is that the device "does not raise new questions of safety and effectiveness" and "is at least as safe and effective."
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.
§ 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).