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510(k) Data Aggregation
(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 | <5 mL/min at 70 ± 3.5 cmH2O | <5 mL/min at 70 ± 3.5 cmH2O |
Note: The submission asserts "The filtration of the two devices shows that the filtration performance is identical," meaning the RT016 is expected to perform identically to the predicate device for these critical features.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for the test set. The language used refers to "performance testing" and "results of the performance testing" without detailing the number of units tested. The data provenance is presumed to be from the manufacturer (Fisher & Paykel Healthcare) and conducted in their facilities or contracted labs, likely within New Zealand (country of origin of the submitter). The testing is retrospective in the sense that it relies heavily on the established performance of the predicate device's components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device performance study (bench testing) for filtration and physical characteristics, not a diagnostic imaging study requiring expert interpretation or ground truth establishment by clinical experts.
4. Adjudication Method for the Test Set
Not applicable for this type of technical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (breathing circuit bacterial filter). This device does not involve human reader interpretation or diagnostic effectiveness that an MRMC study would assess.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a "standalone" physical filter, in the context of typical AI/software device terminology, this question refers to algorithmic performance. Since the RT016 is a physical filter and not a software algorithm, this question is not applicable. The performance described is the inherent physical filtration and flow characteristics of the device.
7. The Type of Ground Truth Used
The ground truth used for performance validation is based on standard engineering and microbiology test methods for filters (e.g., measuring bacterial and viral filtration efficiency, resistance to flow, internal volume, compliance, and gas leakage according to recognized standards like BS EN ISO 23328-1:2008 for the salt test). The "ground truth" for the RT016's expected performance is derived directly from the previously established and accepted performance of its identical filter media and components from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This refers to a physical medical device. There is no "training set" in the context of an AI/machine learning model. The device's design is based on established engineering principles and materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI model, there is no ground truth established in that sense. The device's performance is validated through physical and microbiological bench testing against industry standards and comparisons to its predicate.
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