(287 days)
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)
| Acceptance Criteria Category | Specific Metric | Predicate Device (OMRON NE-C801) Performance (Adult Mask, Albuterol Sulfate) | Subject Device (JOYTECH NB-1103) Performance (Adult Mask, Albuterol Sulfate) | Comparison Result/Implicit Acceptance |
|---|---|---|---|---|
| Aerosol Particle Size Distribution | MMAD (μm) | 4.173±0.126 | 3.466±0.173 | Subject device has smaller MMAD, potentially better penetration. Considered "Equivalent." |
| GSD | 1.845±0.046 | 1.988±0.033 | Slightly higher GSD for subject device, indicating a wider particle size distribution. Considered "Equivalent." | |
| Coarse Particle Fraction (%) (>4.7μm) | 45.607±2.486 | 35.924±2.212 | Subject device has lower coarse particle fraction. Considered "Equivalent." | |
| Fine Particle Fraction (%) ( or ). It does not involve human experts establishing a "ground truth" in the way a diagnostic imaging study would. The data generated is objective, quantitative measurements of aerosol properties by an instrument. Therefore, this question is not applicable to the type of non-clinical study described. |
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.
§ 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).