(263 days)
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.
The Airvo 3 provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.
The F&P Airvo 3 is a high-flow device comprised of heated humidifier with integrated flow source, intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P Airvo 3 can be reprocessed for use on multiple patient interfaces, heated breathing tube, and water chambers are disposable and are for single patient use only, however, the internal outlet elbow is high-level-disinfected for multi-patient use.
The F&P Airvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The flow is adjustable, where a separate source of oxygen independently controlled can be input and mixed with the entrained air. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P Airvo 3 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
The provided text pertains to the FDA 510(k) clearance of the F&P Airvo 3 device, a high flow humidified oxygen delivery device. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, focusing on non-clinical performance data and adherence to recognized standards.
However, the document does not contain information regarding:
- Specific acceptance criteria values and reported device performance in a table for each performance test.
- Sample sizes used for test sets, their data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- The specific type of ground truth used (e.g., pathology, outcomes data), if applicable to this type of device.
- Sample size for training sets.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical (bench) testing and adherence to recognized standards to demonstrate substantial equivalence, rather than clinical study results with human participants or AI performance metrics.
Therefore, I can provide the available information from the document, but many of your requested points cannot be answered based on the input.
Available Information from the Document:
1. A table of acceptance criteria and the reported device performance
The document states that comparative performance testing was performed to demonstrate substantial equivalence and to meet the Special Controls requirements of 21 CFR 868.5454. It lists the categories of performance testing but does not provide a table with specific quantitative acceptance criteria or detailed reported device performance values for each.
| Test Category | Basis for Evaluation | Specific Acceptance Criteria & Reported Performance |
|---|---|---|
| Blending accuracy | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Flow rate accuracy | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Continuous use thermal stability | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Humidification output | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Biocompatibility | ISO 10993-1, ISO 18562-1 (recognized by FDA). | "demonstrates an appropriate biocompatibility profile for the device." (No specific criteria/values provided.) |
| Electrical Safety | ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012 | "The system complies with... demonstrated the appropriate electrical safety profile for the device." (No specific criteria/values provided.) |
| EMC | IEC 60601-1-2:2014, AIM Standard 7351731 Rev. 2.00 2017-02-23 | "The system complies with... demonstrated the appropriate electromagnetic compatibility profile for the device." (No specific criteria/values provided.) |
| Alarms | ANSI AAMI IEC 60601-1-8:2006 and A1:2012 | Testing performed, implies compliance. (No specific criteria/values provided.) |
| Software | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software verification, validation and hazard analysis was conducted, and documentation was provided as recommended." (No specific criteria/values provided.) |
| Cleaning/Reprocessing | AAMI TIR30:2011 | Outlet Elbow classified as semi-critical, subject to cleaning and high-level disinfection. (No specific criteria/values for cleaning effectiveness provided.) |
| SpO2 Sensing (New Feature) | Internal testing by F&P | "F&P has conducted testing that demonstrates that the SpO2 and pulse rate values calculated by the pulse oximetry system are not corrupted during communication to the Airvo 3 and are displayed accurately on the user interface." (No specific criteria/values provided.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data summarized relates to non-clinical (bench) tests rather than human clinical studies.
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)
This information is not provided in the document. The device is a medical equipment (high flow humidified oxygen delivery device), not an imaging or diagnostic AI device that typically relies on expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The F&P Airvo 3 is a medical device, not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an AI algorithm but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in detail. For physical performance tests (like blending accuracy, flow rate accuracy, thermal stability, humidification output), the "ground truth" would implicitly be defined by the measurement standards and calibrated reference equipment used during bench testing. For biocompatibility, it's adherence to ISO standards; for electrical safety, adherence to IEC/ANSI AAMI standards.
8. The sample size for the training set
This information is not provided in the document. This device does not appear to involve machine learning or AI models with "training sets" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided in the document. As noted above, this type of device does not typically have "training sets" or "ground truth" established in this manner.
§ 868.5454 High flow humidified oxygen delivery device.
(a)
Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Alarm testing must be performed;
(ii) Continuous use thermal stability testing must be performed;
(iii) Humidity output testing must be performed; and
(iv) Blender performance testing must evaluate fraction of inspired oxygen (
Fi O2 ) blending accuracy.(3) Performance data must validate cleaning instructions for any reusable components of the device.
(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) A description of available
Fi O2 ranges for different flowrates and inlet gas pressures;(ii) Instructions for applicable flowrates for all intended populations;
(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
(v) A description of all alarms and their functions.