(231 days)
The F&P Evora Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Evora Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Evora™ Full Face Mask (hereafter named "Evora Full") is a non-invasive compact full-face mask that seals underneath the patient's nose and lips. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurised air from a continuous positive airway pressure device (CPAP or Bi-level). The exhaust holes on the seal of the mask allow exhaled air to be flushed out while the system is in operation. The Evora Full mask is a prescription only device, provided in non-sterile state
This document is a 510(k) summary for the F&P Evora™ Full Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its own performance metrics against expert ground truth.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document as it outlines a substantial equivalence argument for a medical device.
However, I can extract information regarding some performance data and the comparison to the predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state acceptance criteria in the format of a requirement with a corresponding performance metric for the subject device to pass. Instead, it compares the subject device's technical specifications to those of the predicate device (F&P Vitera™ Full Face Mask, K190713). Substantial equivalence implies that the differences do not raise new questions of safety or effectiveness.
| Design / Technological Characteristic | Predicate Device (F&P Vitera™ Full Face Mask, K190713) | Subject Device (F&P Evora™ Full Face Mask) | Comments (Implying "Acceptance" through Equivalence) |
|---|---|---|---|
| Classification | 21 CFR §868.5905 | 21 CFR §868.5905 | Identical |
| Intended Use/Indications for Use | The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses. | The F&P Evora Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Evora Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses. | Identical |
| Availability | Prescription use only (Part 21 CFR 801 Subpart D) | Prescription use only (Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Adult (> 30kg) | Adult (> 30kg) | Identical |
| Application | CPAP or Bi-Level therapy | CPAP or Bi-Level therapy | Identical |
| Operating Environment | Home, hospital or other clinical setting | Home, hospital or other clinical setting | Identical |
| Pressure Range | 4 to 30 cmH2O | 4 to 30 cmH2O | Identical |
| Resistance to Flow (at 50 L/min) | 0.24 ± 0.15 cmH2O | 0.9 ± 0.3 cmH2O | This difference does not raise new questions of safety and effectiveness. |
| Resistance to Flow (at 100 L/min) | 0.47 ± 0.15 cmH2O | 2.2 ± 0.3 cmH2O | This difference does not raise new questions of safety and effectiveness. |
| Dead Space (Small/S-M) | Small: 245.8 cc | S-M: 162.6 cm3 | This difference does not raise new questions of safety and effectiveness. |
| Dead Space (Large/L) | Large: 321.8 cc | L: 164.1 cm3 | This difference does not raise new questions of safety and effectiveness. |
| Sound Power Level | 29.8 dBA, with uncertainty 2.5 dBA | 28.2 dBA, with uncertainty 2.5 dBA | Substantially equivalent |
| Sound Pressure Level | 21.8 dBA, with uncertainty 2.5 dBA | 20.2 dBA, with uncertainty 2.5 dBA | Substantially equivalent |
| Shelf-Life | 5 years | 2 years | This difference does not raise new questions of safety and effectiveness. |
| Breathing Circuit | Single Inspiratory Tube | Single Inspiratory Tube | Identical |
| Operating Temperature | 5 to 40°C | 5 to 40°C | Identical |
| Storage Temperature | -20 to 50°C | -20 to 50°C | Identical |
| Swivel | 22mm ISO conical connector | 22mm ISO conical connector | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Reusability | Reusable - Multi Patient Use | Reusable - Multi Patient Use | Identical |
| High Level Disinfection Methods | 80°C for 10 mins, 75°C for 30 mins, 90°C for 1 min | 90°C for 1 min | Equivalent. The subject device contains a subset of the high-level disinfection methods compared to the predicate. |
| Accessory (Oxygen/Pressure Port) | Available as a separate part (900HC452) | Available as a separate part (900HC452) | Identical. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a 510(k) summary for a medical device (face mask), not an AI/software device. There is no mention of a "test set" in the context of an algorithm's performance. The "performance data" refers to non-clinical tests conducted on the physical device components. There is no information regarding country of origin or retrospective/prospective nature of any specific data beyond the general regulatory context.
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 document is not about an AI/software device that requires expert-established ground truth for a test set.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance would be engineering specifications and standards compliance, as demonstrated by the non-clinical tests listed.
8. The sample size for the training set
Not applicable. This is not an AI/software device that would have a training set.
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).