(129 days)
The AeroVent Plus™ CHC is a single patient use collapsible holding chamber that provides the means of delivering MDI packaged drugs into a ventilator breathing circuit. The intended environments for use include the home, hospitals and clinics.
The AeroVent Plus™ Collapsible Holding Chamber (CHC) is a single patient use device used for the administration of MDI packaged drugs to mechanically ventilated patients without the need to compromise the integrity of the breathing circuit by having to open the circuit to administer the medication. The AeroVent Plus™ CHC remains collapsed in the breathing circuit until such time that a treatment is required. The AeroVent Plus™ CHC is then expanded while remaining in the circuit and treatment is given. Upon completion of the treatment the AeroVent Plus™ CHC is then once again collapsed in the circuit.
It is designed only for use in the inspiratory limb of a breathing circuit, to accommodate conventional pMDI canisters as well as most pMDI canisters with integrated dose counters (GSK type) while maintaining the counter function.
The medical device, AeroVent Plus™ Collapsible Holding Chamber (CHC), is a single-patient-use device for administering MDI packaged drugs to mechanically ventilated patients without compromising the breathing circuit. It is designed for use in the inspiratory limb of a breathing circuit and accommodates conventional pMDI canisters and most pMDI canisters with integrated dose counters.
This summary describes the device's acceptance criteria and the study that indicates it meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Compared to Predicate Device AeroVent® CHC) | Reported Device Performance (AeroVent Plus™ CHC) |
|---|---|---|
| MMAD (Mass Median Aerodynamic Diameter) | Comparable performance | Comparable to AeroVent® CHC |
| Pressure Leak Testing | Comparable performance | Comparable to AeroVent® CHC |
| Environmental Testing | Comparable performance | Comparable to AeroVent® CHC |
| Mechanical Life Cycle | Comparable performance | Comparable to AeroVent® CHC |
| Use with Integrated Dose Counters | Maintain counter function for pMDI products with integrated dose counters | Allows for activation of the counter (unlike predicate devices) |
| Fittings | Comply with ISO5356-1 standard | Complies with ISO5356-1 standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the non-clinical tests (MMAD, Pressure Leak Testing, Environmental Testing, Mechanical Life Cycle). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts and Their Qualifications for Ground Truth
No experts were used to establish ground truth for a test set, as this device's performance was evaluated through non-clinical laboratory testing comparing it to a predicate device, not by diagnostic accuracy or interpretation by human experts.
4. Adjudication Method for the Test Set
No adjudication method was used for a test set involving human interpretation, as the evaluation relied on non-clinical engineering and performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The device is not an AI-assisted diagnostic tool, and its effectiveness was demonstrated through non-clinical comparison to a predicate device.
6. Standalone Performance Study
Yes, a standalone performance was done in the sense that the device itself was subjected to several non-clinical tests (MMAD, Pressure Leak Testing, Environmental Testing, Mechanical Life Cycle) and its performance was compared to a predicate device.
7. Type of Ground Truth Used
The ground truth or benchmark for the performance tests was established by comparison to a legally marketed predicate device (AeroVent® Collapsible Holding Chamber) and compliance with an industry standard (ISO5356-1). This is a form of device performance comparison against a known standard/predicate, rather than expert consensus, pathology, or outcomes data typically associated with diagnostic devices.
8. Sample Size for the Training Set
No training set was described or utilized, as this device relies on mechanical and material properties rather than machine learning algorithms.
9. How 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).