(85 days)
The PocketSpacer 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 PocketSpacer is a cylindrical tube, approximately 10 cm 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 off-center actuations. An open mesh with varying size circular orifices, but no valve, is in the round mouthpiece. The mesh with concentrically placed circular orifices removes the throat dose by permitting only respirable particles to be inhaled by the user.
Here's an analysis of the provided text regarding the PocketSpacer device, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the PocketSpacer. Instead, it relies on a comparison to a predicate device (MicroChamber) and general performance improvements over MDI alone. The acceptance is implicitly based on the device performing "comparably" to the predicate for key metrics and "finer, more highly respirable aerosols" than MDI alone.
| Acceptance Criteria (Implicit) | Reported Device Performance (PocketSpacer) |
|---|---|
| Comparable Total Dose | Performed comparably to MicroChamber |
| Comparable Respirable Dose | Performed comparably to MicroChamber |
| Comparable Mass Median Aerodynamic Diameter (MMAD) | Performed comparably to MicroChamber |
| Finer, More Highly Respirable Aerosols than MDI alone | Provided finer, more highly respirable aerosols compared to MDIs alone |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document states "four categories of drugs" were tested. It does not specify the number of individual tests, devices, or MDI actuations performed for each drug category.
- Data Provenance: Not explicitly stated. However, given that Ferraris Medical Inc. is a US company and the submission is to the US FDA, it's highly probable the testing was conducted within the United States. The study appears to be prospective as it's a performance test for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" here is objective physical measurements (total dose, respirable dose, MMAD) obtained through a standardized laboratory test (Cascade Impactor Test), not expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable for this type of performance study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases where subjective interpretation is involved (e.g., grading medical images). Here, the results are derived from objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The PocketSpacer is a physical medical device, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, a "standalone" performance test was done, although it's crucial to understand the context. The "Performance Data" section describes a laboratory test (Cascade Impactor Test) that directly measured the device's physical performance (total dose, respirable dose, MMAD) when used with MDIs. This is a standalone assessment of the device's physical capabilities, independent of human interaction beyond operating the test equipment.
7. The Type of Ground Truth Used
The "ground truth" was established by objective, quantitative laboratory measurements using the Cascade Impactor Test. These measurements directly assess the physical properties of the aerosol produced (total dose, respirable dose, mass median aerodynamic diameter).
8. The Sample Size for the Training Set
This information is not applicable as the PocketSpacer is a physical medical device, not an AI algorithm that requires a training set. The "training" for such devices involves engineering design, prototyping, and manufacturing process development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the equivalent would be the R&D and engineering processes, where design specifications and performance targets are set, and verified through various tests and simulations to ensure the device performs as intended.
§ 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).