(236 days)
The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.
The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.
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 for JOYTECH Healthcare Co., Ltd.'s Compressor Nebulizer (K243468) primarily details the substantial equivalence of the new device to a predicate device, focusing on non-clinical performance testing, specifically particle size characterization.
It's important to note that this document does not describe a study involving human subjects or artificial intelligence (AI). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications for a nebulizer, evaluated through laboratory testing against a predicate device and relevant standards. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, adjudication methods, and training sets for algorithms are not applicable to this specific device clearance.
Below is an interpretation of the provided information within the framework of your request, focusing on the relevant parts and explicitly stating where information is not available or not applicable.
Acceptance Criteria and Device Performance for JOYTECH Compressor Nebulizer (K243468)
The acceptance criteria for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (Omron Compressor Nebulizer Systems NE-C801, K110860) and by meeting relevant performance standards, particularly regarding aerosol particle characterization. The 'study' proving this is primarily the "Particle Size characterization testing" detailed in the submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by performing "comparative particle test comparison" against the predicate device. The goal is to show that the proposed device performs similarly or equivalently to the predicate across key aerosolization parameters. The performance data provided is the direct result of this testing.
Table: Comparative Particle Test Comparison (Summary of Select Parameters)
| Test Item | Endpoint (Acceptance Criteria Implicitly Compared to Predicate) | Subject Device (JOYTECH NB-1103) Performance (Range across drugs/interfaces) | Predicate Device (OMRON NEC801) Performance (Range across drugs/interfaces) | Comparison Result (as per Submitter) |
|---|---|---|---|---|
| MMAD ($\mu$m) | Particle size distribution suitable for inhalation therapy, comparable to predicate. | 3.413 - 5.757 | 3.7 - 6.248 | Equivalent / Similar |
| GSD | Particle size distribution uniformity, comparable to predicate. | 1.764 - 2.381 | 1.605 - 2.141 | Equivalent / Similar |
| Respirable Dose ($\mu$g) | Amount of drug delivered in respirable range, comparable to predicate. | 51.307 - 1628.633 | 50.723 - 1239.14 | Equivalent / Similar |
| Respirable Fraction (%) | Proportion of aerosolized drug in respirable range, comparable to predicate. | 39.103 - 67.958 | 31.781 - 63.741 | Equivalent / Similar |
| Total Delivered Dose ($\mu$g) | Total amount of drug delivered, comparable to predicate. | 112.976 - 2562.202 | 146.303 - 2131.073 | Equivalent / Similar |
| Total Delivered Dose Fraction (%) | Proportion of initial drug dose delivered, comparable to predicate. | 21.305 - 49.063 | 27.55 - 40.801 | Equivalent / Similar |
| Fine Particle Fraction (%) (4.7$\mu$m) | Percentage of particles greater than 4.7 $\mu$m, comparable to predicate. | 35.232 - 64.547 | 39.467 - 72.054 | Equivalent / Similar |
| **Ultra-Fine Particle Fraction (%) ( |
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).