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The Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments. They are for single patient use only.

The Hybernite RT is a breathing system heater according to 21 CFR§ 868.5270. A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway. The Device family "Hybernite RT" is the name for dual wire passive heated breathing circuits optimized for patient category and application. The Hybernite RT is optimized for 3 patient categories, adult, paediatric and neonatal. Within each patient category there is a dual limb and single limb version to accommodate the specific clinical application as tabulated below; the device is intended to act as a conduit for the breathing gasses delivered from the ventilator to the humidifier, from the humidifier to the patient and if applicable from the patient to the ventilator. The product family of Hybernite RT is defined as the combination of non- heated and heated breathing tubes intended to deliver the desire air temperature at the patient port when used in combination with a Humidifier. The Hybernite RT tubing has a range of tubing dimensions (Internal diameter from 10 mm to 22 mm and length from 0.3 meter to 2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element. All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification. The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated. The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to the Hybernite RT. All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors. The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.

The provided document is a 510(k) summary for the Hybernite RT, a heated breathing circuit. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical data and testing conducted.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance that would typically be found in an AI/diagnostic device submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices through compliance with established standards and comparable performance characteristics for a breathing system heater.

The performance characteristics evaluated are:

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/diagnostic algorithm using patient data. The testing described is primarily for engineering and safety performance of the physical device.

• Performance Testing: "Comparative performance testing has been done for the Hybernite RT and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated Humidifier." No specific sample size (e.g., number of circuits, number of test runs) is provided, nor is the provenance of this testing (e.g., conducted internally, by a third-party lab, country of origin).
• Biocompatibility Testing: "All materials utilized in the Hybernite RT circuits have been evaluated according to tests outlined in ISO 10993-1." This involves material samples, not a patient test set.
• Usability Study: "The device has been subject to a usability study according to IEC 62366." The number of participants or details of the study are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The device is a heated breathing circuit, and its performance and safety are evaluated against engineering standards and physiological parameters (e.g., temperature, flow resistance), not by expert interpretation of medical images or diagnostic data. Therefore, there is no "ground truth" in the sense of expert consensus on diagnostic findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, there is no test set requiring expert adjudication for ground truth establishment.

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 a submission for a physical medical device (heated breathing circuit), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no human-in-the-loop performance study or MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm for this device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the typical sense for an AI/diagnostic device. For this physical device, "ground truth" for performance is established by objective measurements against harmonized standards (e.g., ISO, IEC) and internal specifications. For instance, temperature measurements are compared against a maximum allowable temperature (40°C), and resistance to flow is measured and compared against ISO 5367 requirements. Biocompatibility is assessed through standardized tests on materials.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no training set or AI component.

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The Hybernite Rainout Control System is a heated breathing circuit intended to provide warmed and/or humidified breathing gases before entering the patient airway. The Hybernite device is intended for incorporation into CPAP (continuous positive airway pressure) devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. After the gas is warmed and humidified in the humidifier, it is delivered through the heated tubing to the patient. The purpose of the Hybernite Rainout Control System is to maintain or raise the gas temperature to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit, and problems associated with such. The Hybernite Rainout Control System is indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. The Hybernite Rainout Control System is indicated for non-invasive ventilation.

The Device family "Hybernite Rainout Control System" is the name for a heated tubing system consisting of a heated tube and power supply. The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The Hybernite heated breathing tube has standard cuffs on both the machine-end cuff and mask-end cuff. As such, the Hybernite heated breathing tube can be connected to heated humidifiers and flow generators that have standard male outlet connectors.

The Plastiflex Healthcare Hybernite Rainout Control System (K100104) is a heated breathing tube intended to provide warmed and/or humidified breathing gases for CPAP devices.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in a quantitative manner (e.g., specific thresholds for temperature maintenance or condensation reduction). Instead, it states that the device "meets design and performance functional requirements" and complies with relevant international standards.

Here's a summary of the implicit acceptance criteria based on the device's intended use and comparison with predicate devices, and the general statement of performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical or performance testing data with a defined sample size. The testing carried out seems to be primarily bench testing for functional requirements and compliance with standards. It does not mention clinical data or patient-specific data provenance (e.g., country of origin, retrospective/prospective). The document explicitly states: "Clinical data was not required for this submission."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Given that "Clinical data was not required for this submission" and the testing primarily involved compliance with engineering and performance standards (e.g., IEC, ISO), there is no mention of experts (like radiologists) establishing ground truth for a clinical test set. The "ground truth" for this device's performance is based on the adherence to established engineering and medical device standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is mentioned. The assessment is based on compliance testing against predefined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data was not required for this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a heated breathing tube, not an AI/algorithm-based diagnostic or therapeutic system. Its performance is inherent to its physical design, materials, and electrical heating mechanism.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

• Engineering and Performance Standards: Compliance with international standards such as IEC 60601-1, ISO 5367, and ISO 5356-1.
• Functional Requirements: Demonstrating the ability to warm air above the dew point and reduce condensation through bench testing.
• Material Suitability: Selection of polymeric materials suitable for medical applications.
• Substantial Equivalence: Comparison to legally marketed predicate devices, implying that their established safety and effectiveness serve as a benchmark.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/machine learning algorithm, this question is not relevant.

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