(89 days)
The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.
The provided text refers to a 510(k) premarket notification for the "Infant Flow Nasal CPAP Masks." This is a medical device submission seeking clearance based on substantial equivalence to predicate devices, rather than a de novo submission requiring extensive clinical trials to prove efficacy. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics, large-scale clinical study details, MRMC studies, ground truth establishment for training, etc.) is not present in the provided document.
Here's an analysis based on the available information:
Key Takeaway: The submission leverages the existing clearances of similar CPAP systems and states that no additional clinical tests were performed because the mask's function is the same as the already cleared prongs in the Infant Flow System, with only differences in facial mounting and labeling. The core argument for equivalency relies on non-clinical testing demonstrating no differences in safety or effectiveness when using the mask compared to the prongs.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Metric | Device Performance | Notes |
|---|---|---|---|
| Safety | No significant differences in safety compared to predicate and existing components of the Infant Flow System. | "Non-clinical testing of the Infant Flow System using the mask as compared to the prongs demonstrated no differences in safety..." | The document highlights that the mask provides the "same function" as the nasal prongs from the previously cleared Infant Flow System. |
| Effectiveness | No significant differences in effectiveness compared to predicate and existing components of the Infant Flow System in providing CPAP. | "...or effectiveness." | The document indicates that the mask is "similar in purpose" to other CPAP masks and provides the "same function" as the nasal CPAP prongs already part of the Infant Flow System. |
| Performance (Functional Equivalence) | Ability to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or recovering from RDS. | This is the stated intended use and functionality, asserted to be equivalent to the existing prongs. | The mask is described as a "silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs." |
No specific quantitative acceptance criteria or detailed performance metrics are provided in the document. The basis for clearance is substantial equivalence, primarily supported by the argument that the mask functions identically to already cleared components within the same system.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical test set as described in the prompt. The document explicitly states: "Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs and the SensorMedics Infant Flow Mask, no additional clinical tests were performed or submitted in the premarket notification."
- Data Provenance: The "non-clinical testing" mentioned is not detailed, so its provenance (country of origin, retrospective/prospective) is unknown. It's likely internal lab testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No clinical test set with ground truth established by experts is described for this specific device (the mask). The determination of safety and effectiveness relied on "non-clinical testing" and a claim of functional equivalence to previously cleared devices/components.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring expert adjudication is described for this 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?
- Not applicable. This device is a nasal CPAP mask, not an AI diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device (mask), not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Not applicable for this specific device's clearance. The "ground truth" for the clearance of the mask was the established safety and effectiveness of the predicate devices and the existing prongs within the Infant Flow System, as determined by previous FDA clearances (K962848, K974303, K960359, K945740). The current submission relies on non-clinical testing to demonstrate the mask's equivalence to those established components.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI system is involved.
§ 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).