Search Results

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)

Note: The ranges represent the lowest and highest values across the tested drugs (Albuterol Sulfate, Ipratropium Bromide, Budesonide) and patient interfaces (adult mask, child mask, mouthpiece) for both adult and pediatric conditions. The "Comparison Result" is the submitter's statement from the document.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The tables show mean and standard deviation values for each parameter, implying multiple measurements were taken for each drug and interface combination. However, the exact number of replicates (sample size for each data point in the tables) is not explicitly stated in the provided text. It is typically standard practice in such testing to perform a minimum of triplicate measurements.
• Data Provenance: The data is generated from laboratory performance testing of the device and its predicate. This is a non-clinical study.
  • Country of Origin: The manufacturer, JOYTECH Healthcare Co., Ltd., is located in Hangzhou City, Zhejiang, China. The predicate manufacturer, Omron Healthcare, Incorporated, is typically based in Japan with a strong presence in the US. The testing itself would have been conducted in a certified lab, likely in China or an associated region.
  • Retrospective or Prospective: This is prospective laboratory testing conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This study does not involve expert interpretation of medical images or patient data to establish a ground truth. Instead, it involves physical and chemical measurements (particle size and drug delivery) performed on the nebulizer using standardized laboratory methods outlined in FDA guidance and relevant ISO standards (e.g., ISO 18562 series). The "ground truth" is derived from these objective measurements and comparison to the predicate's performance.

4. Adjudication Method for the Test Set

Not applicable. As this is laboratory performance testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results are quantitative measurements.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical device for drug delivery, not an AI diagnostic or assistive tool for human readers. Therefore, there is no human-in-the-loop performance to improve with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is hardware (a compressor nebulizer), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is objective physical and chemical measurement data obtained through standardized laboratory protocols (e.g., cascade impaction for particle sizing, chemical analysis for drug quantity) rather than expert consensus, pathology, or outcomes data. The acceptability is determined by evaluating if these measurements are comparable to the well-established performance of a predicate device already on the market and align with general principles for effective nebulizer function.

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. There is no "training set" or "ground truth" in the context of an AI model for this device.

Ask a specific question about this device