(480 days)
The RT265 and RT266 infant breathing circuits are intended to deliver humidified breathing gases for administration to an infant patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidifies gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways, for example use of an endotracheal tube.
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.
The RT265 and RT266 dual heated infant 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 minimise the formation of condensate.
The RT265 and RT266 are dual-heated breathing circuits, unchanged from the predicate devices (RT235 and RT236). This means that there is a heater wire in both the inspiratory and expiratory limb.
The inspiratory limb is identical in all aspects to that of the predicate device. The expiratory limb is of a different design to that of the predicate, reflecting the change in material.
This document is a 510(k) summary for the Fisher & Paykel Healthcare RT265 and RT266 Dual Heated Infant Breathing Circuits. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way typically expected for AI/ML devices. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.
Therefore, many of the requested categories are not applicable to this document. However, I can extract the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Non-Clinical Tests) |
|---|---|
| Pneumatic performance equivalent to predicate | Testing performed; showed substantial equivalence |
| Single fault and fire prevention equivalent to predicate | Testing performed; showed substantial equivalence |
| Patient leakage current equivalent to predicate | Testing performed; showed substantial equivalence |
| Performance equivalent to predicate | Testing performed; showed substantial equivalence |
| Duration of use equivalent to predicate | Testing performed; showed substantial equivalence |
| Overall safety and effectiveness for intended purpose | Demonstrated to be at least as safe and effective as predicate |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in terms of number of units tested, but comparative performance testing was conducted.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Fisher & Paykel Healthcare Limited. This is a retrospective comparison against the characteristics of their existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a non-clinical device performance comparison, not an expert-driven ground truth assessment.
4. Adjudication method for the test set
- Not applicable. This is a non-clinical device performance comparison.
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 is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used
- Not applicable in the context of AI/ML ground truth. The "ground truth" here is the established performance and safety characteristics of the predicate device (RT235 and RT236), which the new devices (RT265 and RT266) are compared against through physical and functional testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).