(109 days)
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.
The proposed device is the identical VibraPEP™ cleared under K153441 but with a Valved T-adapter and mouthpiece that allow the user to connect a general purpose jet nebulizer.
The VibraPEP™ is an Oscillatory PEP (OPEP) device that looks like a curved shaped pipe with a plastic mouthpiece at one end. A long hose is attached inside. As the patient blows through the VibraPEP™, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect with pressure during the exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to achieve optimal therapy for each patient. The VibraPEP™ facilitates mucus clearing by generating and delivering an oscillation effect that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
This document is a 510(k) Summary for the VibraPEP™ Mucus Clearing Device, detailing its substantial equivalence to previously cleared devices. It primarily focuses on the device's physical and functional characteristics, and its performance in comparison to predicate devices, particularly regarding its use with a nebulizer.
However, the provided text does not contain information typically found in acceptance criteria or study designs for performance of an AI/ML device. This document describes a medical device (a mechanical positive expiratory pressure device), not an AI/ML algorithm. Therefore, many of the requested elements regarding AI/ML device performance (e.g., sample size for AI test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable or present in this document.
I will attempt to answer the questions based on the information available, noting when the information is not present or not applicable to this type of device.
1. A table of acceptance criteria and the reported device performance
The document frames "performance" in terms of physical characteristics (pressure, amplitude, flow, frequency) and how these are maintained when new accessories are added, rather than acceptance criteria for an AI model's output metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion is implicitly that the device's performance characteristics are "not significantly changed" or "no differences" compared to the predicate devices, ensuring functional equivalence.
| Feature | Acceptance Criterion (Implicit) | Reported Device Performance (VibraPEP™ with Valved T-adapter) |
|---|---|---|
| PEP Performance | Performance (Average Pressure, Average Pressure Amplitude, Average Flow Rate, Frequency) with Valved T-adapter should not be significantly altered compared to VibraPEP™ without T-adapter and predicate RC-Cornet with its T-adapter. This demonstrates "no differences between performance" and "no different questions of safety and effectiveness." | Across Settings 1, 3, and 5 (Flow Rate 10, 20, 40 lpm): |
- Ave. Pressure (cmH2O): 9-13 (10lpm), 18-21 (20lpm), 29-40 (40lpm). Compared favorably to VibraPEP™ without T-adapter (10-13, 18-21, 27-41) and Predicate RC-Cornet (10-15, 19-22, 30-41).
- Ave. Pressure Amplitude (cmH2O): 5-13 (10lpm), 19-24 (20lpm), 46-58 (40lpm). Compared favorably to VibraPEP™ without T-adapter (7-17, 22-28, 51-76) and Predicate RC-Cornet (5-18, 20-26, 50-60).
- Frequency (Hz): 8-15 (10lpm), 16-17 (20lpm), 18-21 (40lpm). Compared favorably to VibraPEP™ without T-adapter (8-15, 16-17, 17-21) and Predicate RC-Cornet (9-16, 17-21, 17-21).
- Ave. Flow Rate (lpm): 10 (10lpm), 20 (20lpm), 40 (40lpm). Consistent with expected values. Conclusion: "Results show that there no differences between performance." |
| Nebulizer Performance | Performance (MMAD, GSD, Total Dose, Respirable Dose, Particle distributions) of general purpose jet nebulizers should not be statistically significant altered when connected to VibraPEP™. | For Westmed - VixOne and Hudson RCI MicroMist (with Albuterol, Cromoly Sodium, Ipratropium Bromide): - MMAD (um): Varied slightly (e.g., VixOne Albuterol: 1.7 standalone vs. 1.37 with VibraPEP).
- GSD: Varied slightly (e.g., VixOne Albuterol: 2.24 standalone vs. 2.21 with VibraPEP).
- Total Dose (ug): Varied (e.g., VixOne Albuterol: 1256 standalone vs. 1050 with VibraPEP).
- Total Respirable Dose (0.5-5): Varied (e.g., VixOne Albuterol: 896 standalone vs. 790 with VibraPEP).
- Coarse Particle (>4.7): Varied.
- **Fine particle (
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).