(91 days)
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:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Requirement: Maintain or raise gas temperature to or above the dew point of air exiting the humidifier. | "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." and "Testing carried out on the Hybernite indicates that it meets design and performance functional requirements." |
| Functional Requirement: Reduce or eliminate water condensation and/or pooling in the breathing circuit. | "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." and "Testing carried out on the Hybernite indicates that it meets design and performance functional requirements." |
| Safety Standard Compliance: Electrical safety and essential performance (IEC 60601-1). | "It meets the requirements of international electrical standards for safety and performance, IEC 60601-1..." |
| Performance Standard Compliance: Breathing tubes for anesthetic apparatus and ventilators (ISO 5367). | "...and performance and safety requirements from particular standards for heated breathing tubes: ISO 5367..." |
| Universal Connector Compliance: Conical connectors (ISO 5356-1). | "...and the universal connectors are in compliance with ISO 5356-1..." |
| Biocompatibility/Material Suitability: Polymeric materials suitable for medical purposes. | "The device is made of polymeric materials which have been selected on their suitability for medical purpose." |
| Equivalence to Predicate Devices: As safe, effective, and performs as well as (or better than) predicate devices (K071958 and K041900) regarding intended use, mode of action, and applicable standards. The detailed comparison table in the submission implicitly serves as the criteria for substantial equivalence. | "The information discussed above demonstrates that the Hybernite Rainout Control System is as safe, as effective, and performs as well as or better than the predicate devices." |
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.
§ 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).