(828 days)
The 900PT561 heated breathing tube is for delivery of humidified respiratory gases. For use with AIRVO™ and AIRVO™ 2 Series humidifiers in hospitals and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface.
The 900PT560 and 900PT560E heated breathing tube is for delivery of humidified respiratory gases. For use with myAIRVO™ and myAIRVO™ 2 Series humidifiers in homes and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface.
Compatible patient interfaces: nasal cannula, tracheostomy direct connection, mask adapter.
The AirSpiral heated breathing tube is an accessory to the AIRVO 2 Series Humidifiers and comes in various packaging configurations with or without a humidification chamber, for hospital, long term care, or home use. The tube wall is made from air filled plastic spirally wound in a concentric manner to form the lumen. The trapped air in the plastic utilizes the thermal insulation properties of air. The heater wire is also wound into the wall of the tube to provide direct heating of the tube wall instead of being placed in the gas path. These features help reduce condensation inside the tube.
The AirSpiral heated breathing tube represents an alternative to the existing predicated heated breathing tube accessory in the predicate AIRVO 2 Series Humidifier K131895. It is provided in the same packaging configurations, can be used on AIRVO and AIRVO 2 Series humidifiers over the complete flow range, and uses similar patient interfaces, as the predicate breathing tube and patient interfaces. The patient interfaces consist of Nasal Cannula, Tracheostomy Direct Connection, and Mask Interface Adapter. Of the nasal cannula, spare part Wigglepads for Junior nasal cannula are available to replace those fitted on the cannula if needed. They provide adhesion to hold the cannula in place on the patient. Humidification chambers consist of an autofeed chamber with feedset, and a manual fill chamber, to contain water for humidification.
The document describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the AirSpiral Heated Breathing Tube to its predicate device.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| I. Non-Clinical Performance | ||
| Condensation | (Implied: Show an improvement in condensate accumulation over the predicate line of tubes.) | Passed (showed an improvement in condensate accumulation over the predicate line of tubes) |
| Pressure Loss with Bending | (Not explicitly stated, but implied as meeting acceptable levels for device function.) | Passed |
| Leak Testing | (Not explicitly stated, but implied as no leaks with or without an interface.) | Passed |
| Connection Forces | (Not explicitly stated, but implied as appropriate connection forces for each connector.) | Passed |
| Tensile Strength | (Not explicitly stated, but implied as sufficient tensile strength for the tube.) | Passed |
| Useful Life | Tubes will last at least 2 weeks in hospital/long-term care, and 60 days in home/long-term care environments, and pass leak test, electrical test, and pull test. | Passed (Tubes met the useful life requirements for all environments, passing leak, electrical, and pull tests.) |
| Biocompatibility | Evaluation in accordance with FDA guidance document "Use of International Standard ISO 10993-1," for Cytotoxicity, Sensitization, Muscle Implantation, Genotoxicity, and Extractables/Leachables. Toxicological risk assessment based on chemical characterization following ISO 10993-17 with calculated margin of safety. | Passed (Biocompatibility evaluation conducted and passed for Cytotoxicity, Sensitization, Muscle Implantation, Genotoxicity, and Extractables/Leachables. Toxicological risk assessment with calculated margin of safety for each chemical characterized was performed and passed.) |
| Compatibility with Oxygen | Device to be compatible with oxygen under normal and single-fault conditions. | Passed |
| Environmental (ISTA 2A) | Device to function normally after storage, transportation, and drop testing. | Passed |
| II. System Performance (ISO 8185:2007, in conjunction with AIRVO 2 Series Humidifiers) | ||
| Max Accessible Surface Temp | Surface temperature 43 °C | Met (Heating was interrupted when delivered gas temperature exceeded 43 °C) |
| Max Thermal Overshoot Enthalpy | Overshoot specific enthalpy 33 mg.L-1 for invasive patient interfaces; > 10 mg.L-1 for non-invasive patient interfaces | Met (Humidity output > 33 mg.L-1 for invasive patient interfaces and > 10 mg.L-1 for non-invasive patient interfaces) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., how many tubes were tested for condensation, useful life, etc.). It generally states that "The AirSpiral Heated Breathing Tubes passed the acceptance criteria for all tests."
- Test Set Sample Size: Not explicitly stated for most tests, but testing was performed on "The AirSpiral Heated Breathing Tubes" which implies a representative sample.
- Data Provenance: The studies were non-clinical performance and biocompatibility tests conducted by the manufacturer, Fisher & Paykel Healthcare, based in Auckland, New Zealand. The data is thus internal, prospective test data generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert review of medical images or data from human subjects to establish ground truth. The "ground truth" here is objective physical and chemical measurements against defined engineering and regulatory standards.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical performance and biocompatibility testing. Ground truth was established through validated measurement methods and adherence to scientific and regulatory standards (e.g., ISO 8185, ISO 10993).
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
This is not applicable. The device is a heated breathing tube, not an AI-powered diagnostic or assistive tool for human readers. No MRMC studies were conducted or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a medical accessory (heated breathing tube), not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for the tests was based on:
- Pre-defined engineering specifications and performance targets (e.g., for pressure loss, tensile strength, condensation reduction).
- Compliance with recognized international standards (e.g., ISO 8185:2007 for system performance, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility).
- Regulatory requirements laid out in FDA guidance documents.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical component, not a machine learning or AI model. Therefore, no "training set" in the context of AI development was used.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no training set used for an AI model.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).