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510(k) Data Aggregation
(380 days)
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas. The RT236 is used for flow rates between 0.3 and 4 L/min, and the RT235 is for flow rates greater than 4 L/min, for infant patients.
The RT138 and RT141 dual heated neonatal breathing circuits are classified as 'Breathing System Heater' according to 21 CFR §868.5270. Infant breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimises the formation of condensate. The RT138 is for gas flows of 0.3 - 4 L/min and the RT141 is for gas flows greater than 4 L/min.
This document describes a 510(k) premarket notification for the Fisher & Paykel Healthcare RT138 and RT141 Dual Heated Neonatal Breathing Circuits. The core of the submission revolves around demonstrating substantial equivalence to predicate devices (RT130 and RT131 Neonatal Breathing Circuits) rather than presenting a novel device with extensive performance studies against acceptance criteria in the typical sense of a diagnostic AI product.
Therefore, the requested information cannot be fully populated as it applies more directly to a diagnostic AI device's performance evaluation. However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance (Inferred from conclusions) |
|---|---|---|
| Materials Biocompatibility | Bio-compatibility according to ISO 10993-1, or prior use in a predicate device, or justification for minimal testing. | All materials either evaluated per ISO 10993-1, previously used in predicate, or justification provided. |
| Inspiratory and Expiratory Limb Performance | Meet design and functional requirements for gas flow, temperature maintenance, and condensate minimization. (Specific metrics not provided). | Meets design and performance functional requirements. |
| Electrical and Thermal Safety | Compliance with relevant electrical and thermal safety standards. (Specific standards not provided). | Meets design and performance functional requirements. |
| Intended Use Equivalence | Capable of delivering humidified breathing gases for infant patients, consistent with predicate devices. | Intended use is the same as the predicate devices. |
| Safety and Effectiveness Equivalence | Equivalent to or better than predicate devices in terms of safety, effectiveness, and performance. | RT138 and RT141 are equivalent to or better than the predicate devices in terms of safety, effectiveness and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing" which would imply a test set, but it's focused on engineering and material performance rather than clinical data. It's likely that a small number of physical devices were tested for each category.
- Data Provenance: Not specified, but given the manufacturer is based in New Zealand, the testing would likely have been conducted internally or within a testing facility in New Zealand or a collaborating country. The data is most likely prospective in the sense that the tests were conducted specifically for this submission on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this submission. The "ground truth" here is established through engineering and material testing against predefined specifications and standards, not through expert clinical consensus on patient data. The "experts" would be engineers, materials scientists, and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data reviews (e.g., expert reads of medical images). This document describes engineering and material testing.
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
No. This is not an AI or diagnostic imaging device, and therefore, an MRMC comparative effectiveness study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI or diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is primarily:
- Engineering Specifications and Standards: The device's performance (e.g., gas flow, temperature, electrical safety) is measured against predetermined design specifications and relevant international standards (e.g., ISO 10993-1 for biocompatibility).
- Predicate Device Performance: The RT138 and RT141 are compared to the performance characteristics of the previously cleared RT130 and RT131. In areas like the inspiratory limb, being "identical in all aspects" to the predicate acts as a form of ground truth.
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. As above, no training set was used.
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