(297 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance (Hybernite RT) |
|---|---|
| Material Safety (Biocompatibility) | ISO 10993 compliant; tests for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation, Extractables and leachables. (No risks identified for any patient populations). |
| Device Performance (Breathing Circuit) | Meets design and performance functional requirements. Comparative performance testing with Intersurgical Predicate utilizing Fisher & Paykel MR 850 Heated Humidifier showed equivalence in specified performance characteristics. |
| - Resistance to flow | ISO 5367 compliant |
| - Compliance (mlpa), Tube Volume | ISO 5367 compliant |
| - Gas temperature (Max) | The raising of the gas temperature does not exceed 40°C. |
| Electrical Safety | IEC 60601-1 (Basic safety and essential performance, Electrical, Basic safety and essential performance, Mechanical) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Basic safety and essential performance, EMC) |
| Usability | Subjected to a usability study according to IEC 62366, which demonstrated the utility of the device and user interface for its intended use and environment. |
| Specific Standards Compliance | ISO 5367 (Breathing tubes), ISO 5356-1 (Conical connectors), ISO 8185. |
| Substantial Equivalence to Predicate Device | Demonstrates substantial equivalence and does not raise new safety and effectiveness issues. Shares same intended use, operating principle, basic heated wire breathing circuit design elements, performance characteristics, and applicable standards compliance with predicates. |
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.
§ 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).