(65 days)
ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.
This device is intended for prescription use.
The device consists of an MDI Adapter, a Chamber, a Mouthpiece, a Duckbill Valve, an Exhaust Valve and a Silicone Cap. There are no electrical or electronic components.
Here's a breakdown of the acceptance criteria and study information for the ProChamber™ Valved Holding Chamber, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Particle Size Distribution: Acceptable particle size range compared to predicate device. | "Testing documentation showed that particle size range and reproducibility compared to the predicate device, was acceptable." The device was also compared to an MDI alone without the spacer. |
| Reproducible Dose Delivery: (Implicit, derived from comparison to predicate) | The document states the subject and predicate devices share "Reproducible dose delivery." |
| Minimization of Aerosol Disposition in Oropharynx: (Implicit, derived from comparison to predicate) | The document states the subject and predicate devices share "Minimization of aerosol disposition in oropharynx." |
| Safety and Effectiveness: No new questions of safety or effectiveness compared to predicate. | "non-clinical testing included in this submission demonstrated that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device." This is the overarching acceptance criterion for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a numerical sample size for the "particle size distribution testing." It simply states "ProChamber ™ and the predicate device, the AeroChamber Plus™ , were tested for particle size distribution testing."
The data provenance is also not explicitly stated in terms of country of origin. The test was a non-clinical test performed according to the methodology outlined in the FDA "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/93." This suggests it was a laboratory-based study, not involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device underwent non-clinical testing (particle size distribution) rather than clinical studies requiring expert ground truth for interpretation of patient data.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical trial or testing that would require an adjudication method. The evaluation was based on objective physical measurements (particle size distribution).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable." The evaluation was based on non-clinical, laboratory testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device (valved holding chamber for MDIs), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance was evaluated inherently "standalone" in a laboratory setting in terms of its physical properties.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical testing was based on objective physical measurements of particle size distribution, compared against established guidelines (FDA "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/93") and comparison to the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" for its development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
§ 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).