(230 days)
This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.
Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).
This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).
The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.
Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Biological Evaluation (ISO 10993-1:2018) | Conforms to requirements |
| Basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017) | Conforms to requirements |
| General requirements for basic safety and essential performance (IEC 60601-1 Ed 3.2:2020) | Conforms to requirements |
| Anaesthetic and respiratory equipment - Conical connectors (ISO 5356-1:2015) | Conforms to requirements |
| Usability engineering (IEC 62366-1:2015 + A1:2020) | Conforms to requirements |
| Flow Range: 5 to 70 L/min | Achieves 5 to 70 L/min (Identical to predicate) |
| Shelf Life: 18 months | Achieves 18 months (Identical to predicate) |
| Storage Temperature: -10 °C to +50 °C | Achieves -10 °C to +50 °C (Identical to predicate) |
| Reusability and Duration of Use: Single patient use only for a maximum period of 24 hours | Complies (Identical to predicate) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
- Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.
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 respiratory gas delivery interface, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used:
The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).