(281 days)
The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets.
The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.
The device described Airworks™ Nebulizer pe1200m is not an AI/ML device.
This device is a nebulizer which is a medical device that converts liquid medicine into a mist that can be easily inhaled into the lungs. The provided document is a 510(k) summary for its clearance. The summary focuses on comparing its physical characteristics and aerosol performance with a predicate device. There is no mention of AI/ML components or functionalities.
Therefore, the requested information regarding acceptance criteria and study for an AI/ML device cannot be extracted from this document.
§ 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).