(124 days)
The F&P Eson Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Eson Nasal Mask is intended for single-patient adult use in the home and multiple-patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Eson™ is a respiratory mask which is non-invasive. The silicone seal is positioned over the nose and it seals on the area around the nose and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor to received pressurized gases. On the elbow are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The F&P Eson™ Nasal Mask has a diffuser system that is designed to diffuse air that is expelled from the mask. This reduces the draft. The diffuser does not significantly change the amount of air flowing from the mask, therefore the mask can be used with or without the diffuser system. The air may also be humidified and/or oxygen enriched. An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.
The provided document describes a 510(k) submission for the F&P Eson™ Nasal Mask. This submission focuses on demonstrating substantial equivalence to a predicate device (Fisher & Paykel Healthcare Zest™ Nasal Mask) rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Here's an analysis based on your request, highlighting what information is available and what is not available in the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured/compared?) | Reported Device Performance (What did the F&P Eson™ do?) |
|---|---|
| Performance (general) | Substantially equivalent to predicate device (Zest™ Nasal Mask) |
| Biocompatibility | Substantially equivalent to predicate device (Zest™ Nasal Mask) |
| Intended Use | Matches predicate device (CPAP or Bi-Level Ventilator treatment, single-patient adult home use, multiple-patient adult hospital/clinical use) |
| Design Differences (e.g., RollFit Seal, ball elbow, diffuser, headgear, headgear clips) | Described as design features, but not explicitly stated as performance metrics with acceptance criteria. The document claims they reduce draft, increase movement range, increase stability, etc., but without quantifiable performance against a specific standard or predicate. |
Missing Information: The document does not provide specific quantifiable acceptance criteria (e.g., "leak rate less than X L/min," "pressure drop less than Y cmH2O"). Instead, it relies on a qualitative claim of "substantial equivalence" to the predicate device for performance and biocompatibility.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing" and "test reports" (in Appendix B, which is not provided), implying non-clinical, bench-top testing rather than human subject testing with a "test set" in the context of clinical performance.
- Data Provenance: Not explicitly stated for specific test data. The manufacturer is based in Auckland, New Zealand. The tests were "compared to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask," which implies the testing was done by or for the manufacturer.
- Retrospective or Prospective: Not applicable as it pertains to non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This type of information is relevant for studies involving human interpretation or diagnosis. The provided documentation focuses on non-clinical engineering and biocompatibility comparisons.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- No. This is a medical device (nasal mask) and not an AI/imaging diagnostic device. Therefore, MRMC studies are not relevant to this submission.
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 (expert consensus, pathology, outcomes data, etc.)
- For non-clinical performance: The "ground truth" was established by comparing the F&P Eson™ Nasal Mask's characteristics and performance to the predicate device (Fisher & Paykel Healthcare Zest™ Nasal Mask). This means the predicate device's established performance was used as the benchmark for "substantial equivalence."
- For biocompatibility: The "ground truth" would be established against recognized biocompatibility standards and comparison to the predicate device's known biocompatibility.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device Performance and Study:
The "study" described in the 510(k) summary is a set of non-clinical tests comparing the F&P Eson™ Nasal Mask to its predicate device, the Fisher & Paykel Healthcare Zest™ Nasal Mask, for performance and biocompatibility. The conclusion states that these tests "demonstrate substantial equivalence." The actual test reports containing specific data are referenced as being in "Appendix B," which is not provided here.
The document does not detail specific, measurable acceptance criteria that the device had to meet independently. Instead, the primary "acceptance criterion" for this 510(k) submission was to demonstrate that the F&P Eson™ Nasal Mask is substantially equivalent to the predicate device in terms of safety, effectiveness, technological characteristics, and intended use.
§ 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).