(225 days)
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.
The Care2 Medical Small Volume Nebulizer is a single patient use device. The device is filled with a liquid medication and connected to an air source via flexible tubing. Once the gas comes in contact with the liquid medication, the gas shatters the liquid into small particles. These particles then hit a baffle which further reduces the size of the particles. The smaller particles are administrated to the patient as the patient breathes. The larger particles settle inside the device returning the mist to a liquid to repeat the process until a majority of the medication is nebulized. The Care2 Medical Nebulizer is unique in that it has a side port which allows the user to add medication to the nebulizer without removing the top. The Small Volume Nebulizer is packaged non-sterile in a polyethylene bag.
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All components meet dimensional, visual, and functional requirements on part/assembly drawing. | "All components of the Care2 Medical Nebulizer met the dimensional, visual and functional requirements listed on the part/assembly drawing." |
| All materials meet ISO 10993 Part-1, "Biological Evaluation of Medical Devices" requirements. | "All materials used in the fabrication of the Care2 Medical Nebulizer met the requirements of ISO 10993 Part-1, 'Biological Evaluation of Medical Devices'." |
| Performance (specifically particle size distribution) is substantially equivalent to predicate devices. | "Particle size distribution testing showed that the performance of the Care2 Medical Nebulizer was substantially equivalent to that of the predicate devices." (Predicate devices: Hudson Hand Held (T "Up-Draft) Nebulizer K760489, Airlife Misty Max 10 Nebulizer K023602, and Circulaire Nebulizer K926055). This implies that the particle size distribution of the Care2 Medical Nebulizer is within an acceptable range compared to these established devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set used for the "dimensional, visual and functional requirements" or the "biological evaluation." For the particle size distribution testing, the document does not specify the exact sample size. However, the nature of such testing typically involves a statistically significant number of devices to ensure representative data.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) submission for a medical device in the US, it is highly likely the testing was conducted in a controlled environment as part of the device development and validation process, which would be considered prospective for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of "experts" in the context of establishing ground truth for the test set as would be typical for image-based diagnostics. The assessment of dimensional, visual, and functional requirements is typically done by quality control personnel following established specifications. Biological evaluation (ISO 10993) involves standardized laboratory testing, not human expert consensus for ground truth. Particle size distribution is measured using scientific instruments.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1, none) is mentioned or applicable given the nature of the tests (quality control checks, biological evaluation, and instrument-based particle size measurement). These are objective tests with predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The Care2 Medical Nebulizer is a drug delivery device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance evaluation for the Care2 Medical Nebulizer, particularly for particle size distribution, is a standalone performance evaluation of the device itself (the "algorithm" in this context being the device's design and function). There is no "human-in-the-loop" for its primary function of aerosolizing medication, as the device's efficacy is based on the physical properties of the aerosol it produces.
7. The Type of Ground Truth Used:
- Dimensional, Visual, and Functional Requirements: The ground truth is established by the specified requirements and tolerances outlined in the part/assembly drawings.
- Biological Evaluation: The ground truth is compliance with the requirements of ISO 10993 Part-1.
- Particle Size Distribution Testing: The ground truth is the performance (particle size distribution) of the legally marketed predicate devices. The new device's performance is compared against these established benchmarks for substantial equivalence.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here as the Care2 Medical Nebulizer is a physical medical device, not an AI/machine learning algorithm that requires a training data set. The device's design is engineered, manufactured, and tested against specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
§ 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).