(203 days)
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.
The provided text describes two main evaluations for the AeroChamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC):
- Change in Intended Use: Evaluating the device's performance with "Soft Mist Inhaler" (SMI) formulations, in addition to its existing use with Metered Dose Inhalers (MDIs).
- Addition of a New Configuration: Evaluating the "Adult Small Mask" configuration.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to existing methods (SMI alone for the new intended use) or predicate devices (Adult Large Mask for the new VHC configuration). The goal is to demonstrate comparable performance and no new safety/effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Aerosol Characteristics (SMI Use - Adult Flow) | Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) when using SMI with VHC compared to SMI alone. | SMI Formulation 1 (2 APIs): Fine Particle Fraction (FPF) generally increased with VHC (e.g., Ipratropium bromide increased from 66.6% to 70.3-76.0%; Salbutamol increased from 65.5% to 68.5-77.0%). MMAD generally decreased, indicating smaller particles (e.g., Ipratropium bromide from 2.8 µm to 2.1-2.5 µm). |
| SMI Formulation 2 (2 APIs): FPF generally increased with VHC (e.g., Tiotropium bromide from 60.5% to 67.7-79.0%). MMAD generally decreased (e.g., Tiotropium bromide from 3.2 µm to 2.1-2.8 µm). | ||
| SMI Formulation 3 (1 API): FPF generally increased with VHC (e.g., Tiotropium bromide from 62.4% to 64.5-71.7%). MMAD generally decreased (from 3.1 µm to 2.4-2.7 µm). | ||
| Aerosol Characteristics (SMI Use - Pediatric Flow) | Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD) when using SMI with VHC compared to SMI alone at pediatric flow rates. | SMI Formulation 1: FPF generally increased with VHC (e.g., Ipratropium bromide from 53.0% to 70.6-78.4%; Salbutamol from 51.9% to 72.8-77.9%). MMAD significantly decreased (e.g., Ipratropium bromide from 4.9 µm to 1.5-1.8 µm). |
| Aerosol Characteristics (New Adult Small Mask Configuration) | Comparable aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) to the predicate "Adult Large Mask" configuration when used with pMDIs. | pMDI Formulations: Performance metrics (Total Mass Recovered, Fine Particle Dose, Fine Particle Fraction, MMAD) are generally similar between the Adult Small Mask (Subject Device) and Adult Large Mask (Predicate Device). For example, Ipratropium bromide FPF was 93.0% (Subject) vs 90.5% (Predicate). |
| Biocompatibility | Meet ISO 10993 standards for biological endpoints relevant to an externally communicating device with prolonged contact (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, extractables/leachables). | All listed ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables/Leachables with Biological Risk Assessment) were performed by an independent source. (The text states they were performed, implying successful completion, not explicit results). |
| Mechanical Testing | Demonstrate mechanical integrity and performance as expected for the device (e.g., environmental, flow performance, life cycle, drop, resistivity). | Environmental Testing, Flow Performance, Life Cycle Testing, Drop Testing, and Resistivity Verification were performed on the subject device. (The text states they were performed, implying successful completion). |
| Safety and Effectiveness | No new questions of safety and/or effectiveness are raised by the changes. | "The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC (facemask and mouthpiece configurations) used in combination with Soft Mist Inhaler formulations is comparable to use of a SMI formulation alone. Use of the VHC device with an SMI does not raise any new questions of safety and/or effectiveness." |
| "The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask is substantially equivalent to the predicate (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Large Mask). Use of the subject device does not raise any new questions of safety and/or effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size (number of devices or measurements per condition) for the aerosol characterization tests. It provides mean and standard deviation values for the aerosol characteristics, which suggests multiple measurements were taken for each condition.
- Data Provenance: The studies are non-clinical, involving in vitro aerosol characterization testing and biocompatibility/mechanical testing. The data provenance is internal to the manufacturer (or contracted labs) conducting the tests in a controlled laboratory environment. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to controlled lab testing, not clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the studies are non-clinical. The "ground truth" for aerosol characteristics is established by direct physical measurement using standardized laboratory techniques (e.g., cascade impaction, chemical analysis) based on recognized guidance documents ("Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" FDA/CDRH - 1993). Similarly, biocompatibility and mechanical testing follow ISO standards and engineering principles. There are no human "experts" establishing ground truth in the sense of clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable as the studies are non-clinical. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For laboratory-based performance testing, the "ground truth" is determined by reference methods or validated instrumentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The submitted information focuses on the physical and performance characteristics of a valved holding chamber, not a diagnostic imaging AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a physical medical device (a valved holding chamber), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance data presented (aerosol characteristics) is "standalone" in the sense that it measures the device's physical output without human intervention during the measurement process, but not in the context of an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical studies is based on:
- Physical Measurement: For aerosol characteristics, the ground truth is the direct measurement of particle size distribution, mass recovery, and fine particle dose using validated laboratory equipment and methods (e.g., cascade impactors, chemical analysis) as per FDA/CDRH guidance.
- Standardized Protocols: For biocompatibility, adherence to and successful completion of tests defined by ISO 10993 standards (e.g., in vitro cytotoxicity, in vivo sensitization).
- Engineering Specifications/Industry Standards: For mechanical testing (e.g., environmental, flow performance, life cycle, drop, resistivity), performance against pre-defined engineering specifications or relevant industry standards.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #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).