(187 days)
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
The Pocket Chamber Valved Aerosol Holding Chamber is a cylindrical tube, approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Pocket Chamber) | Compared Against |
|---|---|---|
| Total Dose | Performed comparably | AeroChamber, MDI actuator without spacer |
| Respirable Dose | Performed comparably | AeroChamber, MDI actuator without spacer |
| Mass Median Aerodynamic Diameter (MMAD) | Performed comparably | AeroChamber, MDI actuator without spacer |
| Geometric Standard Deviation (GSD) | Performed comparably | AeroChamber, MDI actuator without spacer |
| Resistance to Flow | Performs in accordance with specifications | Not explicitly stated; implied internal specifications |
| Cleaning Instructions Validation | Performs in accordance with specifications | Not explicitly stated; implied internal specifications |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the Cascade Impactor Test.
The data provenance is retrospective, as it describes a study that has already been performed.
The country of origin for the data is not explicitly stated, but given the submitter and FDA contact information, it is likely the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable as the study described is a performance test on a device, not a diagnostic or image-based assessment requiring expert interpretation for ground truth. The "ground truth" here is the objective measurement obtained through the Cascade Impactor Test, measuring physical characteristics of the aerosol.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. There is no human interpretation or consensus required for the physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:
This is not applicable. The device is an aerosol holding chamber, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI or human reader improvement is not 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 physical medical device, not an algorithm. The "performance" described is the device's ability to facilitate aerosol delivery, which is an inherent mechanical function, not an algorithmic output.
7. The type of ground truth used:
The ground truth for the performance study was objective physical measurements obtained through the Cascade Impactor Test. These measurements directly quantify the characteristics of the aerosol produced by the device, such as total dose, respirable dose, mass median aerodynamic diameter, and geometric standard deviation. For resistance to flow and cleaning instructions, it's based on device specifications and validation testing.
8. The Sample Size for the Training Set:
This information is not applicable as there is no "training set" in the context of this device's performance study. Physical devices do not typically undergo "training" in the way an AI algorithm would.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as point 8.
§ 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).