(231 days)
This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.
The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces.
The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.
The medical device in question is the "F&P Optiflow™ Flow Diverter", a nonrebreathing valve (Product Code: CBP).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance (performance) criteria with numerical targets. Instead, it states that "Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness." It implies that the device met the safety and performance standards outlined in the listed ISO and IEC standards.
However, based on the comparison table with the predicate device, we can infer some key performance characteristics. The document emphasizes equivalence to the predicate device, the "OJR215 Pressure Relief Manifold (K173770)".
| Characteristic / Acceptance Criteria (Inferred) | F&P Optiflow™ Flow Diverter (Subject Device) Performance | OJR215 Pressure Relief Manifold (Predicate Device) Performance | Comments (for equivalence) |
|---|---|---|---|
| Indications for Use | In-line pressure relief, limits system pressure within stated specs, for hospital use by qualified professionals. | Protects neonates, infants, children from excessive inspiratory pressure in downstream occlusion in continuous flow systems via nasal cannula. For flow rates 0.5-36 L/min. Upstream of patient, single use, prescription only. | Equivalent (despite slight wording differences, the core function of pressure relief in a respiratory circuit is comparable). |
| Availability | Prescription use (Part 21 CFR 801 Subpart D) | Prescription use (Part 21 CFR 801 Subpart D) | Identical |
| Intended Use Environment | Hospital | Hospital/Institutional | Identical |
| Users | Qualified healthcare professionals | Qualified healthcare professionals | Identical |
| Ambient Operating Temperature | 18 to 26 °C (64.4 to 78.8°F) | 18 to 26 °C (64.4 to 78.8°F) | Identical |
| Shelf Life | Up to 7 years | 3 years | Different (Subject device has longer shelf life, which is generally a performance improvement from a user's perspective, but would have required stability testing). |
| Storage Temperature | -10°C to +50 °C (14 to 122 °F) | -10°C to +50 °C (14 to 122 °F) | Identical |
| Sterility | Device not provided sterile. | Device not provided sterile. | Identical |
| Operating Pressure - Maximum Pressure | Maximum system pressure of 60cmH2O at maximum rated flow rate of 70L/min | Maximum relief pressure is 75 cm H2O at maximum rated flow of 36 L/min. | Equivalent (Both devices are designed to provide pressure relief; the specific maximum pressures and flow rates differ but are within acceptable ranges for their respective claims. The subject device operates at a lower maximum pressure but at a higher maximum flow). |
| Flow Range | 5-70 L/min | 0.5-36 L/min | Equivalent (Both cover a range of flow rates, the subject device covers a higher range). |
| Application/Therapy | Nasal High Flow Therapy | Nasal High Flow Therapy | Identical |
| Principles of Operation | Valve seals, allows gas flow; if relief pressure exceeded, shaft moves, seal opens, pressure relieved, flow diverted to atmosphere. | Valve seals, allows gas flow; if relief pressure exceeded, shaft moves, seal opens, pressure relieved, flow diverted to atmosphere. | Equivalent |
| Inlet Connection | DISS 1240 | Inlet barb | Different (Requires compatibility verification) |
| Outlet Connection | F&P female safety connection | 22mm female taper connection as per ISO 5356-1 | Different (Requires compatibility verification) |
| Housing Material | Polycarbonate | ABS | Equivalent (Both are suitable medical-grade plastics). |
| Plunger Seal Function | Rests on valve body, accurately relieves pressure by opening when relief pressure is reached. | Seals manifold valve during normal use, accurately relieves pressure by opening when relief pressure is reached. | Equivalent |
| Spring Pressure Relief Valve Mechanism | Shaft moved by valve seal that moves when set pressure is exceeded. | Shaft moved by a spring pressure relief valve that moves when set pressure is exceeded. | Equivalent |
| Manifold Shroud / Tamper Prevention | Rear and front caps prevent user modification to preset pressure relief. | Prevents access to pre-set operating pressures and tampering. | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The testing described is non-clinical performance testing against standards. Therefore, concepts like sample size for clinical test data, country of origin, or retrospective/prospective data are not applicable here. The testing would have involved multiple units of the device under various conditions described by the cited standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context. The performance is assessed against engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable. There's no human interpretation or diagnostic assessment that would require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a mechanical pressure relief valve, 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-based device.
7. The type of ground truth used:
The "ground truth" for this device would be its performance against the objective criteria defined in the referenced industry standards (e.g., ISO 80601-2-74:2017 for respiratory humidifying equipment, IEC 60601-1 for basic safety and essential performance, ISO 80601-2-90:2021 for respiratory high-flow therapy equipment). This includes measurements such as maximum pressure relief, flow rates, temperature tolerances, and mechanical integrity, as well as adherence to design principles and safety features.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary:
The document describes a 510(k) submission for a non-AI, mechanical medical device. The "acceptance criteria" are primarily established by compliance with recognized international and national standards for medical devices and respiratory equipment (ISO, IEC, CGA), as well as demonstrating substantial equivalence to a predicate device. The "study" proving this is a series of non-clinical performance and safety tests conducted in accordance with these standards. The concepts of clinical test sets, ground truth by experts, and training sets for algorithms are not relevant to this type of device submission.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).