(68 days)
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
The filter is comprised of a female (22 mm) filter housing, filter media and male (22 mm) filter housing. The filter media is a depth-type, electrostatic, hydrophobic media which traps microbiological and particulate matter. The filter media is held in place between the female and male filter housings. Both the female and male filter housings have standard 22 mm diameter connectors which have been designed to comply with ISO 5356-1.
Here's a summary of the acceptance criteria and study information for the RT016 Inspiratory Filter, based on the provided text:
Acceptance Criteria and Device Performance Study for the RT016 Inspiratory Filter
This submission focuses on establishing substantial equivalence to a predicate device, the RT019 Inspiratory/Expiratory Filter (K050927), rather than defining new acceptance criteria and proving the device meets them in a standalone study. The key argument is that the RT016 shares identical critical components and performance characteristics with the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly the performance specifications of the predicate device, which the RT016 is claimed to match due to identical components and design in critical functions.
| Performance Characteristic | Acceptance Criteria (from predicate/shared components) | Reported Device Performance (RT016) |
|---|---|---|
| Bacterial Filtration Efficiency | >99.9997% | >99.9997% |
| Viral Filtration Efficiency | >99.99% | >99.99% |
| Filtration Efficiency (Salt Test) | 98.17% | 98.17% |
| Resistance to flow @ 15 L/min | 0.35 ± 0.06 cmH2O | 0.35 ± 0.06 cmH2O |
| Resistance to flow @ 30 L/min | 0.71 ± 0.12 cmH2O | 0.71 ± 0.12 cmH2O |
| Internal volume | 38 mL | 38 mL |
| Compliance | 0.13 mL/cmH2O | 0.13 mL/cmH2O |
| Gas leakage |
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).