Search Results

The Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube.

This device is single patient use only for adults.

The Compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

• NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
• NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
• NK-501: Nebulizer Cup, Air Tube, Mouthpiece
  This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

The provided FDA 510(k) clearance letter and summary pertain to a "Compressor Nebulizer" and a "Heated Breathing Tube," but the main body of the 510(k) summary and the comparative particle test tables focus on the "Compressor Nebulizer" (Model NB-1100, NB-1101, NB-1102, NB-1103) and its predicate "NE-C801 Nebulizer Compressor System." The "Heated Breathing Tube" mentioned in the clearance letter is inconsistent with the detailed submission summary. Therefore, the analysis will focus on the Compressor Nebulizer (JOYTECH NB-1103).

Based on the provided document, the acceptance criteria are implicitly derived from the comparative particle test results between the subject device (JOYTECH NB-1103) and the predicate device (OMRON NE-C801). The study aims to demonstrate substantial equivalence by showing that the differences in technological characteristics do not raise different questions of safety or effectiveness. The core of this demonstration lies in the comparative aerosol performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a "pass/fail" format. Instead, it presents a comparison table and concludes that the devices are "Equivalent" or "Similar" for various parameters. For the aerosol performance metrics, the implication is that the subject device's performance should be comparable to, or within an acceptable range of, the predicate device's performance across different drug types and patient interfaces.

Given the structure, the reported device performance is the reported data in the comparative particle test tables. The "acceptance criteria" are implicitly that the subject device's performance metrics (MMAD, GSD, Respirable Dose, Respirable fraction, Total delivered Dose, Total delivered Dose fraction, Coarse Particle Fraction, Fine Particle Fraction, Ultra-Fine Particle Fraction) are comparable to (i.e., not significantly worse than) the predicate device.

Key Performance Metrics for Aerosol Performance (Based on Comparative Particle Test)

4. Adjudication Method for the Test Set

Since the ground truth is established through objective laboratory measurements rather than human interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical laboratory comparison of aerosol performance between the subject device and a predicate device. It assesses the physical characteristics of the aerosol produced, not human reader performance with or without AI assistance. This question is not applicable to this type of device and study.

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

This question typically applies to AI/software as a medical device (SaMD). The device in question is a Compressor Nebulizer, a physical medical device. Therefore, a standalone algorithm-only performance assessment is not applicable. The performance tested is the physical device's ability to generate aerosols.

7. The Type of Ground Truth Used

The ground truth for the device's performance (specifically aerosol characteristics) is established by objective, quantitative laboratory measurements of particle size, distribution, and drug delivery efficiency, as obtained using standard analytical methods (e.g., based on FDA guidance and potentially pharmacopeial standards for aerosol drug delivery systems). This is presented as "Particle Size characterization testing" on Page 13.

8. The Sample Size for the Training Set

The document describes non-clinical testing for a physical device, comparing its performance to a predicate device. There is no mention of a training set as this is not a machine learning or AI-based device. This question is not applicable.

9. How the Ground Truth for the Training Set was Established

As there is no training set for this device, this question is not applicable.

Ask a specific question about this device

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

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.

Ask a specific question about this device