(332 days)
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.
The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.
The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.
The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.
The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
The provided text describes a 510(k) premarket notification for the Pulmogine® Vibrating Mesh Nebulizer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and a study proving those criteria are met for a novel AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML device is not available in the provided text.
The document primarily describes:
- Device: Pulmogine® Vibrating Mesh Nebulizer
- Purpose: Aerosolize liquid medications for inhalation.
- Target Population: Pediatric (5 years and older) and adult patients.
- Setting: Hospital/institutional, home care, schools, long-term care facilities.
- Classification: Class II Nebulizer.
- Predicate Device: Omron Micro Air Vibrating Mesh Nebulizer, Model NE-U22 (K062263).
The "performance test" section (page 5) mentions that the final products must demonstrate comparable aerosol characteristics to the predicate device at adult and pediatric flow rates. These characteristics include:
- Delivered dose (ug)
- Mass median aerodynamic diameter / MMAD (um)
- Geometric standard deviation / GSD
- Total respirable dose (0.5-5um)
- Coarse particle dose (> 4.7um)
- Fine particle dose (
§ 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).