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510(k) Data Aggregation
(206 days)
This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.
This product is not intended to be used on patients with bypassed upper airways.
This product is not intended to be life-sustaining or life-supporting.
This product is not intended for apneic ventilation.
The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.
The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.
Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.
Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source
This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards & predicate comparison) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Flow Rate Accuracy: +/- 10% | Accuracy of +/- 10% (Identical to Primary Predicate) |
| Operating Temperature Range: (Comparable to predicates) | 64°F to 79°F (18 °C to 26 °C) |
| % Oxygen Control: 21 – 100% | 21 – 100% (Identical to Predicates) |
| % Oxygen Control Accuracy: (Based on ISO 11195:2018) | +/- 5% |
| Oxygen Supply Alarm: Triggers if pressure < 40psi | Issues alarm if < 40psi (Equivalent to Predicate) |
| FiO2 Alarm: Triggers if unable to achieve set FiO2 | Device alarms if unable to achieve set FiO2 |
| Power-fail Alarm: Audible alarm for t > 2 minutes | Audible alarm for time, t > 2 minutes |
| Disconnection Alarm: Activated in < 5 seconds | Activated in < 5 seconds |
| Obstruction Detected/Flow Alarm: Activated in < 5 seconds | Activated in < 5 seconds |
| General Alarm: For internal faults | Activated for internal faults |
| Compliance with ANSI/AAMI ES 60601-1:2005/A2:2021 | Tested and confirmed compliant |
| Compliance with IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Tested and confirmed compliant |
| Compliance with IEC 62304:2006 + A1:2015 (Software Lifecycle) | Tested and confirmed compliant |
| Compliance with IEC60601-1-6:2010+AMD1:2013+AMD2:2020 (Usability) | Tested and confirmed compliant |
| Compliance with ISO 17664-2:2021 (Processing of healthcare products) | Tested and confirmed compliant |
| Compliance with IEC 62366-1:2015 + A1:2020 (Usability Engineering) | Tested and confirmed compliant |
| Compliance with AIM 7351731 Rev 3:2021 (EMC for RFID Readers) | Tested and confirmed compliant |
| Compliance with ISO 80601-2-90:2021 (Respiratory high-flow equipment) | Tested and confirmed compliant |
| Compliance with ISO 11195:2018 (Gas mixers for medical use) | Tested and confirmed compliant (specifically for % O2 accuracy) |
| Compliance with ANSI/AAMI ST98:2022 (Cleaning validation) | Tested and confirmed compliant |
The remaining requested information is not applicable to this 510(k) submission as it pertains to an AI/software-driven diagnostic device, which the "F&P Optiflow Air/Oxygen Flow Source" is not. The document describes a physical medical device (breathing gas mixer) with its performance verified through non-clinical bench testing and compliance with relevant safety and performance standards for such equipment.
- Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance testing against engineering specifications and relevant standards for a hardware device, not a test set of data for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic AI is not relevant for this hardware device.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specified output values (e.g., flow rate, oxygen concentration) measured by calibrated equipment during engineering and validation testing, as required by the listed standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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